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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Bentley’s BeFlared FEVAR Bridging Stent Graft System - acknowledging its unique clinical value and confirming its distinction as the first dedicated solution of its kind for complex FEVAR procedures. This recognition marks an important moment in Bentley’s journey to bring next-generation solutions to physicians and patients in the US.

CAUTION – INVESTIGATIONAL DEVICE. Limited by United States law to investigational use.    

Bloomington, Ind. — Cook Medical has enrolled the final patient in the global clinical study of the ZENITH® FENESTRATED+ Endovascular Graft (ZFEN+). This milestone signifies the completion of patient recruitment in the pivotal study and demonstrates Cook’s commitment to innovating medical devices for the treatment of aortic diseases. 

The investigational ZFEN+ clinical study is being conducted under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA) and with authorization for a clinical investigation under Medicines and Healthcare products Regulatory Agency (MHRA). This clinical study will assess the safety and effectiveness of the ZFEN+ used in combination with the investigational Zenith® Universal Distal Body 2.0 Graft (Unibody2), the investigational Bentley BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and the commercially available Zenith® Spiral-Z® AAA Iliac Leg Graft (ZSLE). 

“Now that enrollment is complete, we are one step closer to understanding the outcomes of patients treated with ZFEN+ and, ultimately, to advancing care for patients with complex abdominal and thoracoabdominal aneurysms,” said Johnny LeBlanc, director, product management, Aortic at Cook Medical. “Reaching this milestone is a direct reflection of the dedication shown by our investigator partners, study coordinators, and—most importantly—the patients who supported the study with their time and trust. We look forward to analyzing the data and sharing the results with the clinical community.” 

The ZFEN+ is predicated on the commercially available Zenith Fenestrated (ZFEN) AAA Endovascular Graft but extends the proximal margin of aneurysmal disease that can be treated endovascularly to include patients with more complex aortic disease involving one or more of the major visceral arteries. The ZFEN+ is an endovascular graft which includes up to 5 precisely located fenestrations, or a combination not to exceed a total of 5 made up of fenestrations and 1 scallop (cut-outs from the proximal margin of the endograft material) to accommodate visceral vessels. Physicians can order fenestrations and scallops specifically to match the patient’s unique anatomy. Overall, the ZFEN+ allows for the endovascular treatment of patients with aortic aneurysms and maximizes the seal zone to exclude the aneurysm. The product was granted Breakthrough Designation from the FDA in 2021. 

“Reaching full enrollment in this important clinical study is a major milestone for Bentley and a significant step toward making our BeGraft Bridging stent available to patients in the United States. It underscores the strength of our collaboration with Cook Medical and reflects our shared commitment to advancing innovative vascular solutions that improve patient outcomes,” said Sebastian Büchert, Bentley CEO.  

“Amazing work from the clinical research team on the enrollment of the final ZFEN+ patient. The clock is now ticking for us to have a patient specific solution for complex aortic aneurysms that will optimize seal without compromise,” said Dr. Gustavo Oderich, the global principal investigator of the clinical study.  

Additional information about the clinical study will be available at www.clinicaltrials.gov. 

Bentley has reached a significant milestone with the official ground-breaking ceremony for the next phase of the Bentley Campus in Hechingen. Following the acquisition of the neighboring property from Best Freizeitmöbel at the end of 2023, this third phase of campus development is now underway. The aim is to expand Bentley’s presence while strengthening its roots in the region.

from left: County mayor of the Zollernalbkreis Günther-Martin Pauli, first deputy Dorothee Müllges, Monika Sunnanväder, Lars Sunnanväder, Sebastian Büchert, Annika Sunnanväder, Peter Gärtner (architect), Christian Schmelzle (architect)

MDSAP certified - Ready for product registration in Canada!

Bentley is one of Europe's fastest growing MedTech companies, ranking first in Germany and second in the European manufacturing sector.

Bentley has been recognized by the Financial Times and Statista as one of Europe's fastest-growing companies. In the latest ranking of “Europe's Long Term Growth Champions”, Bentley secured a top position among manufacturing companies:

1st place in Germany, 2nd place in Europe in the manufacturing sector.

This award is based on an impressive foundation: with 52.8% average annual revenue growth over a ten-year period (2013-2023), Bentley is one of the most consistently successful companies in its industry – even in a challenging economic environment marked by global uncertainty, geopolitical tensions, and supply chain bottlenecks.

“Sustained growth over an entire decade demonstrates what Bentley stands for: long-term thinking, technological progress, and strong teamwork. This award is a recognition for the entire team – and a clear signal to the market: Bentley is ready for the next steps in Europe and beyond.”

– Sebastian Büchert, CEO Bentley

MedTech “Made in Germany” – in use worldwide

As an innovation-driven, global medical technology company with production facilities in Hechingen (Baden-Württemberg), Bentley develops, manufactures, and distributes implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. Our products are now used in over 80 countries, contributing to the treatment of life-threatening diseases worldwide.

Our ranking not only marks an economic milestone but also underscores our role as a reliable partner for medical professionals, investors, and talented individuals—for anyone seeking long-term prospects and innovative strength.

About the ranking

The Financial Times publishes the “Europe's Long Term Growth Champions” ranking annually in collaboration with Statista. It recognizes companies that have achieved exceptionally strong revenue growth over a decade. The overall ranking also includes retail and platform companies such as Zalando and Spotify – Bentley plays a leading role among manufacturing companies.

After the official launch of the BeFlow just a day ago, Bentley successfully launched two additional products at LINC in Leipzig: The BeGraft Stent Graft System, the world’s first on-label bridging device, and the BeFlared FEVAR Stent Graft System, the first dedicated indicated bridging stent for FEVAR (Fenestrated EndoVascular Aneurysm Repair) procedures. With this dual market launch of bridging stents used in FEVAR procedures, Bentley is taking on a pioneering role.

"Launching three product news at the same time is the result of team effort and many years of development.  In view of the new, comprehensive EU Medical Device Regulation, this is not only a special moment for us, but certainly also a highlight for endovascular specialists who perform these complex FEVAR procedures," says Sebastian Büchert, CEO of Bentley. “We’re at the forefront of this market, offering solutions that fill a critical gap. The positive feedback and strong demand underscore the significant potential that we have prepared our infrastructure for” he concludes.

The BeFlared is the world’s first dedicated bridging stent for FEVAR procedures. The stent is crimped on a specially designed stepped balloon which will reduce the number of steps that are needed for optimal deployment. Additionally, a third radiopaque marker aids in optimal positioning of the stents in the fenestration. The BeFlared is available in diameters from 5 to 9 mm and in stent lengths of 22, 27 and 37 mm. The flared diameter is 2 to 3 mm larger compared to the native sizing of the stent.

Only two months ago, Bentley announced the successful certification of BeFlared. The commercial market launch of BeFlared at the 2025 edition of the LINC Congress in Leipzig will be framed by interesting scientific presentations, discussions and live cases. One session not to miss is the one with Prof. Stéphan Haulon, a leading French vascular surgeon from the Hôpital Marie Lannelongue of the University of Paris and Bentley's long-time scientific advisor. He will present his first experiences with the BeFlared and will highlight the various advantages in FEVAR procedures. On Thursday, January 30, Prof. Haulon will perform a live case in which he will be using the BeFlared stent. “This dedicated bridging stent allows precise positioning and accurate deployment thanks to a third extra marker on the balloon catheter. The specially designed “stepped” balloon will make sure that the stent can be inflated in one step (positioning and flaring). This is not only a game changer, but one of the most important milestones in the history of fenestrated aortic endografting” summarizes Prof. Stéphan Haulon his experience with the BeFlared stent.

Since the “first in man” of Bentley’s BeFlared performed by Prof. Stéphan Haulon in Paris end of 2024, endovascular specialists around the globe queued up to use this innovative device for the treatment of complex aortic aneurysms. Before the official market launch, more than 200 BeFlared stents were used in patients suffering from complex aortic aneurysms. 12 leading specialists who had the opportunity of using this new stent graft system reported excellent results regarding usability and initial clinical outcomes. Their research letter with feedback on their findings has been published in the European Journal of Vascular Surgery. They agreed that the BeFlared will make fenestrated endografting much simpler and swifter. “We are pleased that the first experiences with the device confirm a shorter overall time for procedural and fluoroscopy per target vessel,“ remarks Prof. Haulon.  

The BeFlared is now commercially available in line with country specific market regulations.

Media Contact
Nadja Atwaa  
Corporate Communications  
Bentley InnoMed GmbH 
Lotzenäcker 3 
72379 Hechingen, Germany
Mobile  +49 151 14124552 
E-Mail    n.atwaa@bentley.global 
Web       www.bentley.global

The Bentley BeFlared: the first dedicated bridging stent for complex FEVAR interventions, allowing precise deployment in one step.

Bentley, a leading manufacturer of balloon expandable covered stents, announces the market launch of its BeFlow iliac covered stent system at the LINC congress in Leipzig, (January 28-30th). It is dedicated to the treatment of iliac occlusive and stenotic diseases and enables physicians to treat patients suffering from arteriosclerosis with a covered stent ensuring safe treatment, long-term patency and durability.

“Our target is to provide a specialized solution for the growing number of patients suffering from diseased iliacs. Bentley has designed the BeFlow covered stent as a focused stent platform addressing stenotic and occluded iliac lesions. Combining all aspects of Bentley covered stent quality, the BeFlow has the potential to become a very competitive alternative in a price-sensitive market segment”, says Martijn Nugteren, Director Sales & Marketing at Bentley. The BeFlow comes in four diameters of 7 to 10 mm and two nominal lengths of 37 and 57 mm. A higher degree of product standardization has a positive impact on production as well as logistic cost, making the BeFlow an affordable solution for the treatment of stenosed iliacs. Martijn Nugteren adds: “Up to now, bare metal stents are still frequently used in heavily stenosed iliac arteries while a covered stent would have been the preferred option. Here, financial aspects influence the decision. With the BeFlow we hope to narrow the cost gap between bare metal stents and covered stents so that patients can be treated with a device that really makes a difference.”

“The BeFlow is a great solution for patients with complex aorto-iliac occlusive disease. When dealing with more simple lesions, Bentley offers an established uncovered balloon expandable stent, the BeSmooth, with the same product features such as a low profile, high visibility and flexibility that we know from the already proven design from the BeGraft. Regarding ease of use during the endovascular intervention, the new BeFlow fulfills all requirements. Particularly, in heavily stenosed or even occluded iliacs, a covered stent is the preferred solution, as it will ensure long-term patency and is in line with the ESVS guidelines for Iliac stenting, where it is stated that covered stents may be considered due to higher patency rates.”, summarized Dr. Koen Deloose, Head of Vascular Surgery AZ Sint-Blasius Hospital Dendermonde in Belgium, who had conducted the “first in man” procedure with a 78-year-old patient suffering from severe claudication. 

Together with Bentley’s BeBack crossing catheter and the balloon-expandable uncovered BeSmooth stent, the BeFlow marks an important extension of the company’s portfolio of peripheral solutions.

The BeFlow is CE certificated and will be commercially available as of February 2025. After the market launch, Bentley plans a Post-Market Clinical Follow-up (PMCF) study, led by Dr. Antonella Ruffino, Lugano, Switzerland, as principal investigator.

Visit the Bentley team at Leipzig Interventional Course (LINC) from January 28-30 at booth #103 to learn more about our products.

Media Contact
Nadja Atwaa
Corporate Communications
Bentley InnoMed GmbH
Lotzenäcker 3
72379 Hechingen, Germany
Mobile  +49 151 14124552
E-Mail    n.atwaa@bentley.global
Web       www.bentley.global

Dr. Koen Deloose and his vascular team.

Beaming faces among the representatives of four social organisations from the Zollernalb region when Bentley CEO Sebastian Büchert announced the results of the company’s annual fundraising campaign and presented the cheques on Friday. The employees in Hechingen had donated cash, holiday days and hundreds of hours of overtime. The corresponding amount of money was doubled by the company, totaling EUR 83,000.

EUR 28,000 went to the Tübingen Children's Cancer Support Association. A good EUR 18,000 each were handed over to the Lebenshilfe Zollernalb foundation, the Youth Life Line from Tübingen and Malteser Neckar-Alb, the latter having been were added to the group of recipients at the suggestion of employees. Representing the four donation recipients, Anton Hofmann, Chairman of the Children’s Cancer Support Association, put it in a nutshell: "It is always impressive to see how committed Bentley's employees are to social issues. This constant support helps us all a great deal in our daily work supporting people who have to cope with disabilities, serious diseases or life crises."

"At Bentley, we are passionately committed to making people feel better - with our products that help to alleviate the consequences of serious and sometimes even life-threatening vascular diseases and with our annual fundraising campaign. It's great to see how this help is being received, especially here in the region," said Sebastian Büchert, CEO of Bentley, at the donation event. This took place in the company canteen in the new building at the Hechingen site, which was inaugurated in summer 2024 to make room for the medical technology company's strong growth.

Shortly beforehand, the Bentley CEO had reviewed the highlights of the past financial year at an employee meeting broadcasted live to all sites. "Together, we achieved a lot again in 2024 and have been successful," he said, praising the team. "We have received approval for three product innovations that endovascular surgeons are already describing as groundbreaking. And we have made good progress in opening up new markets. This is also reflected in the profit-sharing bonus for all employees. Our donation shows that, despite our success, we always keep an eye on those who need our support," says Büchert.

About Bentley

Founded in 2009 as a start-up by Lars Sunnanväder and Miko Obradovic, the medical technology company Bentley InnoMed GmbH is based in the medical technology centre of Hechingen in Baden-Württemberg. The company develops, manufactures and distributes implants and catheters for the minimally invasive treatment of peripheral vascular and aortic diseases and has become the world's leading manufacturer and European market leader for balloon-expanding covered stents. It is part of the Bentley Endovascular Group AB, Sweden. Around 440 employees are committed to the company with its strong culture of innovation. This makes Bentley one of the most important employers in the Zollernalb district and beyond. The company is active in more than 80 countries worldwide. Thanks to its product innovations and the development of new markets, Bentley is on course for healthy, dynamic growth.

The local recipients of donations at Bentley in Hechingen (from left to right): Sebastian Büchert (Bentley InnoMed GmbH), Heike Klinger (Malteser Neckaralb), Thomas Linhart (Malteser Neckaralb), Anton Hofmann (Förderverein für krebskranke Kinder e. V. Tübingen), Markus Urban (Youth-Life-Line, Tübingen), Ines Schenk (Lebenshilfe Zollernalb), Laura Fechter (Lebenshilfe Zollernalb), Holger Klein (Lebenshilfe Zollernalb)

A very moving talk at Zollernalb: during the “Bentley Vascular Talk”, a 59-year-old patient described how Bentley stents not only saved his life but also completely changed his attitude towards life. More than 300 Bentley employees from Hechingen and Switzerland listened rapt with attention to the report of Rainer Baumann (name changed) about his suffering and treatment history as a long-term patient with fissures and bulges in the aorta. In a dialogue with his physician, Prof. Dr. Philipp Geisbüsch, Chief Physician of the Clinic for Vascular Surgery at the Klinikum Stuttgart, and Bentley CEO Sebastian Büchert, he vividly described how Bentley's stents have changed his life for the better.

"The fact that our CEO got wet eyes on the podium says it all about those special moments": this is how Philipp Herbst, Head of Quality at Hechingen-based medical technology company Bentley, describes his impressions of the Bentley Vascular Talk. However, it wasn't just CEO Sebastian Büchert who became very emotional during the innovative in-house talk format in front of 300 employees from Hechingen and Switzerland; one of the employees people he spoke to also had to swallow hard during his talk.

He was even more impressed by the story that the now 59-year-old told. As Baumann reported on the podium, it began 16 years ago when he sat up in the dental chair at the end of a visit to the dentist and suddenly felt "as if someone was stabbing me in the chest". Resting was no use. "I rang my physician: I can't breathe anymore." On the way to the physician’s practice, he felt mortal fear for the first time: "Every heartbeat hurt. I knew that everything was at stake." This was also the view of the physician, who immediately had the 43-year-old transported to the emergency room in Tübingen. There it turned out that the inner layer of the aorta wall had torn. Experts refer to this as an aortic dissection - a life-threatening finding because downstream organs such as the kidneys are no longer adequately supplied and blood pressure rises to immeasurable heights. "The tricky thing about diseases of the aorta is that there are hardly any warning signs beforehand," explained Prof Geisbüsch. "If you feel something, there is already a risk that the aorta will burst." And that is usually fatal.

Only an immediate operation could help Rainer Baumann. In 2008, this meant open surgery under a heart-lung machine. The patient's body was "switched off" for two and a half hours, the torso was cut open once in a semicircle and then shut again with 47 staples. Baumann's aortic aneurysm was repaired, but the operation and its consequences completely traumatised him. "For a year, I felt as if a truck had driven over me," the patient described. He suffered pain, felt numbness in his legs that never completely disappeared - and repression mechanisms set in: he didn't want to see a physician again for eight years, neglected the "aortic check-up", the regular follow-up care that is as important as for cancer patients.

But by 2020 at the latest, Baumann had to face up to the realities: One kidney was already damaged, and dangerous weak points were again recognised in the aorta. Physicians threatened new operations, but Baumann would rather die than be cut open again.

Advances in medical technology promised a way out of the dilemma: in several minimally invasive, endovascular procedures, Rainer Baumann's aorta was almost completely replaced from the heart valve to the groin with customised stents from other manufacturers and numerous bridging stents from Bentley. No one was more amazed at how gently these procedures were performed than the patient himself. With moist eyes, he told the podium how he was able to travel to Berlin just five days after an operation to celebrate a birthday. A completely different world, this type of operation.

At the age of 59, Rainer is not cured, he remains a high-risk patient who needs careful aftercare and has to swallow 14 tablets every morning to keep his blood pressure stable. But his quality of life has been restored thanks to modern surgical techniques - and his attitude to life has completely changed for the better. "It's fantastic," said Rainer Baumann. "I'm no longer afraid." And to the Bentley staff, who were listening spellbound: "What you make possible with your products is much greater than you could have imagined."

Prof Geisbüsch also confirmed this: "What you do makes our work with patients so much easier. Also thanks to stents like those from Bentley, an operation now only takes two or three hours instead of ten in the past." And because of Bentley's high delivery stability, physicians always have the stent of first choice to hand. The vascular surgeon's appeal: "Keep up the good work with these innovations!"

Sebastian Büchert promised: "We are working hard to continue to live up to this reputation". His thanks went to Bentley co-founder Lars Sunnanväder, who was also present, and who had made a major contribution to these innovations by founding the company.

The finale was a very emotional moment for dozens of Bentley employees who were called up by name. All those who - neatly documented - worked on the catheters and stents that saved Rainer Baumann's life were gathered on stage for a group picture with "their" patient. Marina Orsolic, coach for organisational and talent development at Bentley Switzerland, who had travelled by bus from Frauenfeld together with 60 colleagues, summed up what the afternoon had brought to the workforce: "We were shown that our work is extremely meaningful. It fulfils me to be able to work for a company like this."

About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technol­ogy stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 440 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. Based on its product innovations and the development of new markets, the company is on a path of strong growth momen­tum.

Left: Explaining the advantages of Bentley stents for patients and surgeons: Prof Dr Philipp Geisbüsch, Chief Physician at the Clinic for Vascular Surgery at Klinikum Stuttgart.

Right: Fascinated by the descriptions of the long-term aorta patient and his positive experiences with minimally invasive bridging stents from Bentley: CEO Sebastian Büchert at the ‘Bentley Vascular Talk’.

Shortly after receiving the CE certification for its BeFlared Stent Graft System, the world’s first dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR), Bentley announced the successful “first in man” implantation of this product. The procedure was performed by Prof. Stéphan Haulon, vascular surgeon at the Hôpital Marie Lannelongue in Paris. As this marks decisive progress in the company’s strategy to improve clinical outcomes for patients by providing innovative stents for complex endovascular procedures, all Bentley employees had the opportunity to watch the intervention via a live-stream. 

During the minimally invasive surgery, Prof. Haulon first implanted an aortic endo-prosthesis through a small opening in the patient’s femoral artery. Then three BeFlared stents were positioned at the fenestrations of the endo-graft, ensuring an immediate sealing and maintaining blood flow through the visceral arteries to vital organs. In addition, he implanted one regular BeGraft stent at the fourth fenestration. The operation of the 72 year old patient suffering from a severe aortic aneurysm ended after a total procedure time of 80 minutes only. “I am happy to report that the BeFlared met all our expectations regarding ease of use during the intervention, duration and matching the requirements of the patient’s anatomy”, Prof. Haulon summarized. “The recent certification of the BeFlared marks a milestone in the endovascular treatment of aortic aneurysms as it allows to shorten procedure times and therefore reduce x-ray exposure to patients and operation staff significantly. This “2 in 1” device creates a new standard for bridging stents in FEVAR procedures. The BeFlared is a game changer as it makes these interventions safer, faster and enables better outcomes for the patients. It was a pleasure and an honour for me and my team to be part of this development. I dearly thank all Bentley employees involved in the BeFlared project”, added the leading endovascular surgeon from Paris and one of Bentley’s medical advisors.

“The successful “first in man” implantation of the BeFlared confirms our strategy and dedication to develop innovative stents in close cooperation with the endovascular community. In the coming weeks, a group of leading international endovascular specialists will also perform FEVAR procedures with the BeFlared in their centres, sharing further clinical data and practical experience of the various implantations. This is an important phase in the market launch of this ground-breaking bridging stent”, Sebastian Büchert, CEO of Bentley, explained. Together with Carmen Panero Delgado, head of R&D at Bentley, and further team members he followed the BeFlared “first in man” in the operation theatre at Paris.

At Hechingen, Bentley’s CTO Christian Bader provided further commentary to more than 250 Bentley employees who had gathered in the canteen to watch the procedure that was also broadcasted live to the company’s Swiss site in Frauenfeld, and to its global sales offices. Bentley’s founders Lars Sunnanväder and Miko Obradovic (the latter having initiated the development of the BeFlared) also took the opportunity to witness the successful implantation. When Prof. Haulon ended the implantation of the BeFlared, all cheered enthusiastically. Representative of all employees involved in the BeFlared project, Maja Schuster, member of the Product Testing team, got to the heart of the matter: “We are so excited to see how well the BeFlared performed in practice. We all are really proud to have been part of this. We have been testing numerous stents to ensure optimum design and quality. It was demanding, but worth every effort”, she said.

Series production of the BeFlared has started and after the official market launch at the LINC congress in Leipzig, Germany, it will become commercially available as of February 3^rd, 2025, in line with country specific market regulations.

About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technol­ogy stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 440 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. Based on its product innovations and the development of new markets, the company is on a path of strong growth momen­tum.

Media Contact
Dr. Maria Lahaye-Geusen
Communications
Bentley InnoMed GmbH
Lotzenäcker 3
72379 Hechingen, Germany
Tel         +49 7471 9999 191
Mobile  +49 151 14124552
E-Mail    m.lahaye-geusen_ext@bentley.global
Web       www.bentley.global

Happy after a successful “first in man” implantation: Bentley CEO Sebastian Büchert, vascular surgeon Prof. Stéphan Haulon, with Carmen Panero Delgado, head of R&D at Bentley and project lead Atilla Duyar. 

With two certificates granted by TÜV, Bentley achieved another break-through in extending indications for its stents in complex aortic interventions. Thanks to one certificate, the Bentley BeGraft stent now is the world’s first on-label bridging device. The second certificate was received for the newly developed BeFlared, the first-to-market dedicated bridging stent for FEVAR (Fenestrated EndoVascular Aneurysm Repair). Thus, the leading manufacturer of balloon-expandable covered stents again fulfills its dedication to ease the work of physicians and improve clinical outcomes for patients.

FEVAR procedures are necessary when patients suffer from aneurysms extending up to the renal or visceral arteries. In a minimally invasive intervention under X-Ray, custom-designed aortic endo-grafts are implanted to exclude the aneurysm. This procedure requires additional bridging stents to ensure perfusion of vital organs. “For more than 15 years, interventional radiologists and endovascular surgeons around the globe have performed FEVAR procedures with off-label stents. I am very happy that now the BeGraft is certified for use as a bridging stent. The BeGraft has successfully proven to be a means of choice when treating patients with challenging aortic aneurysms”, said Eric Verhoeven, Professor of Vascular Surgery at the Paracelsus Medical University Nuremberg (Germany). Starting in 2021, he had conducted a multi-centric clinical trial using BeGraft in FEVAR procedures with more than 100 patients at 10 participating study centres. The positive results of this study paved the way for the certification initiated by Bentley.

“This certificate for the extended indication of our BeGraft stent graft system certainly is a milestone and improves our competitive edge in serving hospitals, physicians and patients with reliable endovascular solutions. Yet in face of the ever-rising need for FEVAR procedures in aortic repair, we also heavily invested in the development of the next generation bridging stent dedicated to FEVAR procedures: the BeFlared. It right now received the CE-certificate for the use in FEVAR procedures”, Bentley’s CEO Sebastian Büchert remarked on the double win.

The swift certification of the BeFlared is the result of more than four years hard development work of the Bentley team. It was initiated by Bentley’s co-founder Miko Obradovic who came up with the principal idea of a product simplifying bridging stent placement after being present at FEVAR procedures. The project team then developed the BeFlared in cooperation with Bentley’s long-standing scientific advisor Prof. Stéphan Haulon, a leading French endovascular surgeon from the Hôpital Marie Lannelongue at Paris University, together with a team of other international endovascular specialists.

As a dedicated bridging stent, the BeFlared connects the fenestrations of aortic prostheses to the patient’s renal and visceral arteries.  It consists of a uniquely shaped balloon on which the stent is mounted. The tapered shape of the balloon seals the BeFlared stent within the fenestration. A third x-ray marker at the point of the fenestration allows precise positioning of the stent. These two features permit accurate deployment in one step, which is decisive to prevent future complications such as endo-leaks.

In the coming weeks, selected clinical centres will be implanting the new Bentley covered stents for FEVAR procedures. The official market launch is planned at the LINC congress taking place in January, 28th-30th, 2025 in Leipzig, Germany.

About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technol­ogy stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 440 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. Based on its product innovations and the development of new markets, the company is on a path of strong growth momen­tum.

Media Contact
Dr. Maria Lahaye-Geusen
Communications
Bentley InnoMed GmbH
Lotzenäcker 3
72379 Hechingen, Germany
Tel         +49 7471 9999 191
Mobile   +49 151 14124552
E-Mail    m.lahaye-geusen_ext@bentley.global
Web       www.bentley.global

The Bentley BeFlared: the first dedicated bridging stent for complex FEVAR interventions, allowing precise deployment in one step.

Over 450 guests - employees and representatives from business, politics and medicine - celebrated the inauguration of Bentley's new company building in Hechingen last Friday. More than 100 attractive workplaces, a spacious new canteen and logistics areas have been created on around 4,250 square metres and five floors. With this move, the leading manufacturer of balloon-expandable covered stents has reached another milestone in the expansion of its main site in the medical technology stronghold of Hechingen.

“Since its foundation almost exactly 15 years ago to the day, Bentley has been growing extremely dynamically. We are delighted to be able to move into our new ‘Admin II’ building just in time for this anniversary - with plenty of space for new offices as well as a new staff canteen and our new central warehouse. This will create space for the expansion of our high-tech production on our existing premises here in Hechingen,” said Lars Sunnanväder, founder and major share­holder of Bentley. “On behalf of my co-founder, Miko Obradovic, and our shareholders, I would like to thank the Bentley team and all the local companies involved in the construction for their great planning and construction work. Together, they have made it possible for us to finally move into the new building despite the devastating fire in May 2023,” said a delighted Lars Sunnanväder.

The reorganisation of space in the existing and new buildings allows for increased production capacity, also thanks to an additional clean room and laser room. Expanded logistics areas help Bentley to fully utilise one of its strengths in service for hospitals and physicians: the delay-free delivery of all Bentley products. This enables endovascular physicians in over 80 countries to rely on the availability of the right Bentley stent at all times for operations that improve or - depend­ing on the severity of the disease - even save patients' lives. At the same time, it helps hospitals to save costs by keeping stocks low.

The new building, in which owner Lars Sunnanväder invested EUR 13 million, was erected by FBW Fertigbau Wochner. “Innovative ideas, quick decisions and close collaboration on major challenges, such as the installation of the 54 tons prefabricated bridge to Admin II: this is what we have come to appreciate about Bentley and we look forward to further major projects,” reported FBW Managing Director Jürgen Baumeister.

‘Admin II’ is equipped in a sustainable and environmentally friendly way. An air-heat pump and a photovoltaic system help to avoid the consumption of fossil fuels. The photovoltaic roof mod­ules have an output of 96 kWP and generate 130,000 kWh of electricity per year. The fully air-conditioned work places and social areas are designed according to the latest ergonomic stand­ards and in the characteristic Bentley design, which clearly sets the young brand apart from other medical technology manufacturers.

However, a key element of Bentley's DNA is not only pioneering innovations in products and design, but above all a consistent focus on employees. This is also reflected in the concept of the new canteen. Freshly prepared meals are served here every day - with a very special extra. “At Bentley, we attach great importance to team spirit - a challenge with a workforce that is growing almost daily. Shared meals encourage personal interaction across the company. All employees pay the heavily subsidised standard price of just EUR 2.50 for one dish a day for everything - from vegan stew to steak. This makes the daily visit to the canteen even more attractive and encourages communication. This is also part of the Bentley style, like working hard together and jointly celebrating our successes,” says Bentley CEO Sebastian Büchert. The multi-purpose area of the canteen, which is equipped with state-of-the-art presentation technology, can be con­verted for events ranging from product launches and staff meetings to the now legendary Bentley parties.

At the same time as moving into Admin II, the Bentley facility team is already working on the next construction project: on the neighbouring site of Best Freizeitmöbel GmbH, which was acquired at the end of 2023, the Bentley Campus will be built in several construction phases over 45,000 square metres from 2025.

The guest speakers at the opening ceremony were also impressed. Christian O. Erbe, head of the medical technology company of the same name and President of the Baden-Württemberg Chamber of Industry and Commerce, paid tribute to Bentley's rapid development. “Innovative, creative and with a very special corporate culture, Bentley has developed into one of the most attractive employers in our region in just 15 years and is a prime example of the potential that lies right here.”

There was also praise from the medical side: “As a young, ambitious company, Bentley has developed high quality covered stents very quickly. They are extremely flexible and can also be used for very complex operations. Bentley stents remain permeable for a long time and allow sustainable care for patients suffering from aneurysms (arterial protrusions), problems with cor­onary vessels or a disturbed peripheral blood supply, for example in the legs, which in the worst case could lead to amputations. With Bentley stents, we can save patients‘ lives and improve their quality of life,” said Prof. Dr. Eric Verhoeven, Chief Physician at the Clinic for Vascular Sur­gery in Nuremberg. This was confirmed by his French colleague Prof. Dr. Stéphan Haulon from the Hôpital Marie Lannelongue, which is part of the Paris University Hospital network. Together with the team of his research laboratory, in the past six years Prof. Haulon has been supporting the development of a new Bentley stent, which is expected to be launched in 2025. “Bentley is once again on the verge of delivering a game changer for the treatment of endovascular diseases. This will enable us to significantly reduce the duration of the surgical intervention and thus the radiation exposure on patients and OR staff,” says the French specialist.

At the inauguration ceremony, many guests took the opportunity to personally congratulate the Bentley management team on being honored as a finalist in the prestigious EY World Entrepre­neur of the Year Awards. CEO Sebastian Büchert and company founder Lars Sunnanväder were the only representatives of their country to make it through to the final round in Monte Carlo, where they faced the judgement of the jury along with companies from 47 other countries and were honored on 6 June in the big closing event with the finalist award.

About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technol­ogy stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 440 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. Based on its product innovations and the development of new markets, the company is on a path of strong growth momen­tum.

Contact
Dr. Maria Lahaye-Geusen, Communications
m.lahaye-geusen_ext@bentley.global, +49 7471 9999 191, +49 151 14124552

Space for further growth: great view of the Bentley buildings: Production and Admin I (left) and the newly opened Admin II (right); in the background the Best company site, pur­chased for the new Bentley campus.

Last week, the first patient was enrolled in an investigator-initiated study on the treatment of aorto-iliac occlusive disease (AIOD) with the CERAB technique (covered endovascular reconstruction of the aortic bifurcation) using a combination of the Bentley BeGraft aortic Stent Graft System and the BeGraft peripheral Stent Graft System. Dr. Ioannis Passaloglou, chief physician of vascular surgery of St. Gertrauden Hospital, Berlin, successfully performed this minimally invasive procedure. The study is conducted by the Foundation for Cardiovascular Research and Education, approved by the German and Dutch competent authorities, and supported by Bentley.

AIOD diminishes blood flow to the legs and is one of the causes of limb amputation. The CERAB technique in combination with the BeGraft aortic and two BeGraft peripheral stents provide a treatment option especially for high-risk patients for whom open surgery is unsuitable.

“Due to our close contact with leading endovascular experts, we see a rising use of covered stents in the CERAB procedure to remedy AIOD. As so far none of the available covered stents are indicated for this new treatment option, Bentley wants to take on the responsibility to prepare the certification for an on-label application. The enrolment of the first patient in this clinical study is a decisive step to get the CERAB-indication for our BeGraft aortic and BeGraft peripheral stents,” said Sebastian Büchert, CEO of Bentley.

“We are happy to contribute to the clinical investigation on the endovascular treatment of AIOD. The CERAB technique has shown great results so far, and in combination with the Bentley stents, the treatment has major advantages compared to the “kissing stent” technique or the open approach,” said Dr. Ioannis Passaloglou, coordinating investigator of the multi-center clinical study. “Although the procedure is still off-label, the complication rate is lower and the patients’ recovery faster. Together with further clinical data, it may become the new gold standard for treating AIOD and to increase the patency rates in the long-term,” Dr. Passaloglou added.

In general, approximately 16 sites in Germany and the Netherlands will participate in the study. 109 patients will be included with a follow-up period of 24 months.

“This prospective clinical trial will support the on-label certification of the Bentley BeGraft aortic and BeGraft peripheral for the treatment of AIOD. We assume that it will further prove the long-lasting positive therapeutic effects of the CERAB technique leading to a reduced perioperative mortality and morbidity versus open surgical procedures for patients severely suffering from AIOD,” said Dr. Martin Schirling, Clinical Affairs Manager at Bentley.

ClinicalTrials.gov Identifier: NCT05805111

About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technology stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 400 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. Based on its product innovations and the development of new markets, the company is on a path of strong growth momentum.

Contact
Dr. Maria Lahaye-Geusen, Communications
m.lahaye-geusen_ext@bentley.global, +49 7471 9999 191, +49 151 14124552

Today, Cook Medical and Bentley announced a United States distribution agreement for the BeBack crossing catheter. Over the coming months, Cook Medical will be assuming commercial responsibilities for this Bentley product.

“We are excited to welcome Bentley’s BeBack crossing catheter to our peripheral intervention portfolio,” said Alec Cerchiari, director of product management for Cook’s PAD and Venous specialty. "The BeBack crossing catheter is a unique tool for crossing heavily calcified lesions in antegrade or retrograde fashion. It complements Cook’s robust portfolio of above- and below-the-knee products, including our Micropuncture® Pedal Introducer Access Sets, Flexor® Guiding Sheaths and CXI® Support Catheter. "

The BeBack is a crossing catheter designed for steering through chronic total occlusions (CTO) that provides targeted reentry options. The catheter includes features such as:

• A steerable and adjustable nitinol needle
• A radiopaque marker located near the tip of the catheter, which indicates the direction in which the needle curves
• 80 and 120 cm lengths and 2.9F and 4F sizes

“The BeBack crossing catheter is an effective approach for successful recanalisation and should be available in every lab across the U.S. Thanks to this collaboration with Cook, we will now have a better commercial footprint in the U.S. with even more opportunities to treat patients with debilitating arterial and venous disease,” said Martijn Nugteren, Director of Sales & Marketing at Bentley.

Distribution partnerships, such as this one with Bentley, allow Cook to accelerate its product pipeline and bring innovative products to customers and their patients. Cook and Bentley have a long history of collaboration, and this partnership represents another example of working together to advance patient care.

About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technology stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 400 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. In 2022, the company generated sales revenue of EUR 69 million. Based on its product innovations and the development of new markets, the company is on a path of strong growth momentum.

About Cook Medical
Since 1963, Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we invent, manufacture and deliver a unique portfolio of medical devices to the healthcare systems of the world. Serving patients is a privilege, and we demand the highest standards of quality, ethics and service. We have remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities.

Contact
Dr. Maria Lahaye-Geusen, Communications
m.lahaye-geusen_ext@bentley.global, +49 7471 9999 191, +49 151 14124552

The Minister for Economic Affairs, Labor and Tourism visited the Hechingen-based medical technology company Bentley with a delegation of several members of state parliament and Hechingen’s Mayor Philipp Hahn. There were plenty of topics to talk about.

Last Friday, Bentley CEO Sebastian Büchert and CTO Christian Bader welcomed Dr. Hoffmeister-Kraut, Baden-Württemberg’s Minister for Economic Affairs, Labor and Tourism, to a dialogue at the European market leader for covered stents in Hechingen’s Lotzenäcker district. In addition to Manuel Hailfinger (CDU), member of the state parliament and member of the Committee on Economic Affairs, Labor and Tourism as well as the Committee on the Environment, Climate and Energy, Cindy Holmberg, member of state parliament for the Hechingen-Münsingen constituency from Bündnis 90/Die Grünen, took part in the exchange across party lines. Mayor Philipp Hahn also took the opportunity to participate in the exchange between politics, business and science in his municipality located in the heart of the Medical Valley.

At the center of the open discussions were the current issues and challenges facing medical technology production at the Hechingen site, with a focus on the changing political and regulatory framework related to planned EU legislative measures. The potential impact on the production of necessary precursors and the risks to the European supply chain were intensly debated. This included an emphasis on the importance of limiting geostrategic dependencies on countries such as China to maintain long-term competitiveness. All agreed that bureaucracy and reporting requirements have already caused excessive costs and represent a significant constraint that needs to be reduced in a joint effort in the near future. This is why an exchange between policymakers, associations, science and the business sector is so important.

Christian Bader, Bentley’s chief technology officer, pointed out that predictability is critical for investments of all kinds in an industry where time frames of seven to ten years from the initial idea to product approval are the norm.

Dr. Hoffmeister-Kraut emphasized: “Having a direct exchange with companies in the region is particularly important to me given today’s very challenging environment for many areas of the manufacturing industry. Nothing is more valuable than a face-to-face conversation and getting a first-hand impression on the ground. A predictable regulatory framework and reliable supply chains are essential, especially for dynamically growing medical technology companies like Bentley who are planning for the long term. Especially the medical device industry suffers from regulatory requirements and further increase of bureaucracy. I will not cease to promote better framework conditions in Brussels and Berlin.”

About Bentley  
Founded in 2009 by Lars Sunnanväder and Miko Obradovic and based in the medical technology stronghold of Hechingen in Baden-Württemberg, Bentley InnoMed GmbH develops, produces and distributes implants and catheters for the endovascular treatment of peripheral vascular diseases and diseases in the area of the aorta. The company has since developed into one of the world’s leading manufacturers and European market leader for covered stents. Today, more than 400 employees work for Bentley Endovascular Group AB in a strong culture of innovation. Bentley is one of the most important employers in the county of Zollernalb and beyond. The company generated revenues of EUR 69 million in the 2022 financial year and is on a dynamic growth trajectory with its product innovations and the development of new markets.

Contact for further information
Stephan Haas, Corporate Communications, +49 7471 98499 5691, s.haas@bentley.global

In front of the Bentley headquarters: (from left to right) Martin Dürrstein (CEO of Dürr Dental SE); Dr. Tania Fuchs (Deputy Head of Division Healthcare Industry, Chemistry and Materials), Bentley CEO Sebastian Büchert; Minister of Economic Affairs Dr. Hoffmeister-Kraut; Mayor of Hechingen Philipp Hahn; Lukas Derad (R&D), Cindy Holmberg (Member of Parliament from Bündnis 90/DieGrünen), Kevin Wiktor (R&D) and Bentley CTO Christian Bader. Photo: Bentley

CAUTION - INVESTIGATIONAL DEVICE. Limited by United States law to investigational use. 

Bentley announced earlier this week the enrollment of the first US patient in Bentley’s BeGraft and Cook’s Zenith® Fenestrated+ Endovascular Graft (ZFEN+) clinical study. The procedure was performed by the Principal Investigator of the study, Dr. Gustavo Oderich (UT Health Houston, Houston).

“This has been a very important milestone for all of us having the first patient enrolled in this study. Thanks to COOKs ZFEN+ device in combination with Bentley’s BeGraft covered stents we can offer a tailored solution for patients suffering from complex aortic aneurysm,” said Dr. Oderich.

The U.S. Food and Drug Administration (FDA) has granted in the summer of 2023 approval for Cook Medical and Bentley to initiate a joined Investigational Device Exemption (IDE) study. This clinical study will assess the safety and effectiveness of the ZFEN+ used in combination with the investigational Zenith® Universal Distal Body 2.0 Graft (Unibody2), the investigational Bentley BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and the commercially available Zenith® Spiral-Z® AAA Iliac Leg Graft (ZSLE). 

“At Bentley we are pleased that the study potentially could bring this technique a step closer to the American patient suffering from aortic aneurysms” said Sebastian Büchert, CEO, Bentley. “Our covered stents are used all over the world in similar procedures and it would be great if we can have this treatment option available in the US as well, once the study is finished and the results are published”.

The ZFEN+ clinical study is a prospective, multi-center, single-arm study that will include sites in the United States and Europe. Bentley and Cook intend to enrol 102 patients in the pivotal study. The primary safety endpoint is a composite measure of device technical success and procedural safety within 30 days. Likewise, the primary effectiveness endpoint is a composite measure of freedom from aneurysm-related mortality and freedom from clinically significant re-intervention through 12 months post procedure. A composite measure is a group of variables collected during the clinical study and analyzed.

About Bentley

Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technology stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 400 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. In 2022, the company generated sales revenue of EUR 69 million. Based on its product innovations and the development of new markets, the company is on a path of strong growth momentum.

Contact: Matthias Bleesen, Communication & Event Coordinator
m.bleesen@bentley.global, +49 7471 984 995 631

The Hechingen-based company Bentley and its employees have made a record Christmas donation to three socially committed institutions in the region.

“Every year anew” is the year-end refrain at the Hechingen-based medical technology company Bentley as it looks back gratefully on the events and tremendous success of the past fiscal year and combines it with a Christmas donation. As in previous years, the employees, the management, and the company’s owners were all keen to pass on a portion of their profits to those less fortunate.

For the second time since 2022, the donation was distributed among three recipients in accordance with a resolution adopted at the employee general meeting. Fifty percent of the donation was granted to the Foundation for Children with Cancer Tübingen (Förderverein für krebskranke Kinder Tübingen e. V.,)  whose beneficial work the Bentley workforce has already supported on several occasions. Two other socially committed associations from the region – Tübingen’s Youth-Life-Line organization, which helps young people in crises, and the Zollernalb Life Aid Foundation (Stiftung Lebenshilfe Zollernalb), which supports people with disabilities – each received 25 percent.

As in previous years, Bentley’s employees were invited to donate cash or vacation days and overtime, which the company converted into cash. The amount raised was doubled again by Bentley.

Bentley CEO Sebastian Büchert presented the impressive results at an employee meeting on Thursday, December 14, and at the donation ceremony on Friday, December 15. Of the company’s 325 employees, 207 donated a total of 591 vacation hours (equivalent to 75 vacation days), 905 hours of overtime, and EUR 16,090 in cash. The entire donation came to a total of EUR 93,254.80, setting a new record for all Bentley fundraising activities. The previous year’s total, donated to the same three institutions, was EUR 76,499.12.

Anton Hofmann, Chairman of the Foundation for Children with Cancer Tübingen, accepted the donation of EUR 46,627.40 with great gratitude. Holger Klein, member of the Management Board of the Zollernalb Life Aid Foundation and Markus Urban from Youth-Life-Line were also grateful as they each received EUR 23,313.70 from Sebastian Büchert.

With the handover of the donation, Sebastian Büchert explained: “I was very touched by the social commitment and great compassion shown by our employees. Once again, they have shown that they have a big heart for children, young people and their families who find themselves in very difficult situations.” The employees and the management place great importance on being able to support regional projects. The personal contact with these organizations ensures that the donations are in the right hands.

“This is amazing,” said a delighted Markus Urban from Youth-Life-Line. “We have never received such a large donation before.” During its 20-year history, this Tübingen-based organization has already helped over 9,000 young people in suicidal crises.

Holger Klein was equally grateful. This cash gift from Bentley will help provide quality of life and enjoyment to around 600 people with disabilities who are cared for by the Zollernalb Life Aid Foundation.

Anton Hofmann, Chairman of the Foundation for Children with Cancer Tübingen, spoke of the moving personal stories of families with terminally ill children who have found new courage in their everyday lives thanks to the association's support. Bentley has regularly supported the association for many years. All three of the donation recipients asked that Sebastian Büchert pass on their warmest thanks to the Bentley workforce.

Contact for further information
Stephan Haas
Corporate Communications
Tel +49 7471 98499 5691
Mobile +49 151 14124552
Email S.Haas@bentley.global

At the donation handover (from left): Anton Hofmann (Foundation for Children with Cancer), Markus Urban (Youth-Life-Line), Sebastian Büchert, CEO of Bentley, Holger Klein (Zollernalb Life Aid Foundation). Image: Bentley

The rapidly expanding medical technology company Bentley purchased the entire site of the upholstered leisure furniture manufacturer Best Freizeitmöbel GmbH in Hechingen. The site is directly adjacent to Bentley’s existing company premises. Bentley CEO Sebastian Büchert and the Strobel family, owners of Best Freizeitmöbel GmbH, signed the corresponding agreement today.

With this purchase, the European market leader for stents is tripling its site, located in the industrial area between Lotzenäcker and State Highway 410, from 15,000 square meters to almost 45,000 square meters. The previous owner, Best, will gradually hand over the use of the site to Bentley until the middle of 2025. The parties to the agreement have agreed not to disclose the purchase price. Bentley had already acquired a piece of property from Best in 2021, upon which it built the 5-story Bentley parking garage.

Bentley CEO Sebastian Büchert is delighted to have this expansion opportunity located right next door. This is due to Bentley’s plan to vastly increase its stent production. The site expansion will also meet the company’s urgent requirement for new capacity. All other areas in the company – from logistics to research and development – are also in need of space, which will now be a thing of the past. The foundation has thereby been set for the growth strategy in the years ahead.

“We know this situation all too well. Bentley’s dynamic business growth has always outstripped the available space. Our search for interim solutions has opened up new options for the future that we would never have dared to imagine before. So surprisingly, something good has come out of the roof fire misfortune experienced in May of this year. The fact that we have now been offered the option to purchase the Best site right next door in its entirety is a unique opportunity for us. We can finally leave our space concerns behind us. We intend to build a truly attractive and spacious Bentley Campus, where there will be room to catch some air between the buildings, and people can take a stroll when the weather is nice. We will start again planning from the ground up and create a very attractive corporate campus where we can all feel comfortable and enjoy working. I’m very excited about our plans,” says Büchert, who was recently named Entrepreneur of the Year by Manager Magazin and the auditing company EY.

The date for inaugurating the eagerly awaited new building in the Lotzenäcker industrial park has also now been set: June 7, 2024. More than a hundred workstations in this five-story building will bring some needed relief to the company, which is currently bursting its seams. A very visible roof fire that occurred in May 2023 means that Bentley will not be able to move into the new building until June 2024 instead of the original move-in date of September 2023. To bridge this gap, Bentley has been renting alternative space from neighboring companies in the short term. In addition to this space, 30 containers were also needed to accommodate the rapid growth in the number of employees.

The old production buildings and warehouses on the Best site will therefore make way for the new Bentley Campus in the years to come. This will change the future face of the Lotzenäcker business park in Hechingen as well as attract new employees. CEO Büchert plans to employ significantly more people by then to accommodate the company’s dynamic growth. The architectural design of the future campus promises to be quite impressive.

About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technology stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. Acquired in 2023, Qmedics AG is a Swiss specialist in balloon catheters and key supplier to Bentley. More than 420 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. In 2022, the company generated sales revenue of EUR 69 million. Based on its product innovations and the development of new markets, the company is on a path of strong growth momentum.

Contact for further information
Stephan Haas
Corporate Communications
Tel +49 7471 98499 5691
Mobile +49 151 14124552
Email S.Haas@bentley.global

Bentley paves the way for the new Bentley Campus by tripling the size of its Hechingen Lotzenäcker location (in blue, the existing Bentley premises, marked in red the properties purchased from BEST)

CEO Sebastian Büchert and founder Lars Sunnanväder of the medical technology company Bentley are winners of the “EY Entrepreneur of the Year 2023” award. Bentley InnoMed will represent Germany in the global competition for “EY World Entrepreneur of the Year Award 2024”.

The leading-edge medical technology from Hechingen has received outstanding recognition for its entrepreneurial drive and innovation on a grand stage in Berlin. Bentley company founder Lars Sunnanväder and CEO Sebastian Büchert have claimed the internationally renowned “EY Entrepreneur of the Year 2023” business award. The two entrepreneurs from Hechingen not only won first prize in the “Innovation” category, but also remarkably came out on top of all 20 finalists and will represent Germany in next year’s global competition for “EY World Entrepreneur of the Year 2024”.

For Bentley, this is the most prestigious award in our company’s 14-year history,” said an overjoyed Bentley CEO Sebastian Büchert, in his comments on the award ceremony. “I am delighted for Bentley as well as for our employees. It’s wonderful to see our work for patients recognized on such a grand stage. We are especially pleased that we will be the only company representing Germany at the global competition in Monaco on June 6, 2024.” At this global event, Bentley will compete against award-winning, owner-managed mid-sized companies from 60 countries.

The Entrepreneur Award for Germany was presented Thursday evening at the event venue Motorwerk Berlin. Sebastian Büchert and Lars Sunnanväder were part of a show hosted by TV journalist Judith Rakers. The competition, which was launched 27 years ago, is organized by the well-known auditing and consulting firm EY in cooperation with the investment company LGT and business publication Manager Magazin.

The speaker bestowing the award to Bentley was Martin Dürrstein, Managing Director of Dürr Dental AG based in Bietigheim-Bissingen, who won the Entrepreneur Award 2021 in the “Family Business” category. He praised Bentley, founded in Hechingen in 2009, as an outstanding manufacturer of leading-edge medical technology “made in Germany”. Dürrstein underscored how patients around the world benefit from Bentley’s medical products. The company Group, which now has around 420 employees, focuses on minimally invasive treatments for vascular diseases and disorders throughout the body and for all artery diameters. Bentley is one of the most innovative companies in the industry when it comes to development and production, including the only manufacturer to offer a balloon-expandable stent in a diameter range of 2.5 to 30 millimeters. The speaker went on to highlight that, since the market launch of Bentley’s first implant in 2012, the company has demonstrated the same characteristics that make its own products successful: stability where it is indispensable, combined with the greatest flexibility possible – making it essential to the successful work of cardiologists and surgeons in more than 80 countries.

Bentley’s win across all categories is, at the very least, attributable to the company’s unique approach to the employee involvement during its planned initial public offering. Through its BeShareholder program, Bentley gives employees an opportunity to become shareholders in the company. The jury also recognized Bentley’s outstanding investment in the research and development of life-saving products.

The Entrepreneur of the Year award is the icing on the cake of a great entrepreneurial career for Hechingen-based medical technology pioneer Lars Sunnanväder. “I found it was a great honor for us to be one of the few finalists for this prestigious SME award,” explained the 83-year-old. “It is an enormous tribute to the performance of our strong and passionate team that we have now won and can represent Germany on a global level. The fact that our relatively young company has already gained a reputation as an important employer nationwide is outstanding.” And this perception is likely to grow again in the near future: Bentley is featured in a major article in the December issue of Germany’s Manager magazine, titled “Hightech in Handarbeit” (“High-tech by hand”). The article also focuses on the “Bentley style”: The team led by CEO Sebastian Büchert practices a “work hard, play hard” attitude.

For Sebastian Büchert and Lars Sunnanväder, the gala at the Motorwerk in Berlin was also an example of “playing hard”. They were greatly honored to be able to be present when entrepreneur Prof. Dr. Reinhold Würth from Künzelsau received the honorary award for exceptional entrepreneurial and social commitment. Dr. Nicole Hoffmeister-Kraut, Baden-Württemberg's Minister of Economic Affairs, gave the laudatory speech.

About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technology stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. Acquired in 2023, Qmedics AG is a Swiss specialist in balloon catheters and key supplier to Bentley. More than 420 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. In 2022, the company generated sales revenue of EUR 69 million. Based on its product innovations and the development of new markets, the company is on a path of strong growth momentum.

Contact for further information: 
Stephan Haas
Corporate Communications
Tel +49 7471 98499 5691
Mobile +49 151 14124552
Email S.Haas@bentley.global

On the grand stage at the Motorwerk in Berlin: the EY Entrepreneurs of the Year 2023, Lars Sunnanväder (3rd from left) and Sebastian Büchert (4th from left) with last year's overall prize winner Dr. Kuhn from va-Q-tec (3rd from right) and presenter Judith Rakers (2nd from right), as well as the chairman of the jury Dr. Wittenstein and representatives of EY. Image: Bentley

• Lars Sunnanväder, founder and Advisory Board member of Bentley InnoMed GmbH (Bentley), and Sebastian Büchert, CEO, are in the finals for the globally renowned business award “EY Entrepreneur of the Year 2023”, bestowed by auditing and consulting firm EY
   
• Top jury nominates the Sunnanväder-Büchert team as one of Germany’s best in the category “Innovation”

The Bentley team is among the best in Germany in Category “Innovation”. (From left to right) Sebastian Büchert, Bentley CEO and Lars Sunnanväder founder and Advisory Board member

CAUTION: Investigational device. Limited by United States law to investigational use.

Hechingen, Germany - The U.S. Food and Drug Administration (FDA) has granted approval for Cook Medical and Bentley to initiate a joined Investigational Device Exemption (IDE) study on the Zenith Fenestrated+ Endovascular Graft (ZFEN+) in combination with the Bentley BeGraft Balloon-Expandable FEVAR Bridging Stent Graft (BeGraft).

This clinical study will assess the safety and effectiveness of the ZFEN+ in combination with Bentley’s BeGraft for the endovascular treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. The ZFEN+ is predicated on the commercially available Zenith Fenestrated AAA Endovascular Graft but extends the proximal margin of aneurysmal disease that can be treated by an endovascular approach to include patients with more complex aortic disease. For patients with complex aortic disease, the only currently established treatment option is open surgical repair.

“Outside the United States, Bentley has supplied over 300.000 BeGraft peripherals to patients in over 80 countries around the world. We are pleased that this study approval of the FDA brings us one step closer to making our leading technology also available to American patients suffering from vascular diseases,” said Sebastian Büchert, CEO, Bentley.

The ZFEN+ clinical study is a prospective, multi-center, single-arm study that will include sites in the United States and Europe. At this time, the FDA has approved enrollment of the first 30 patients. Ultimately, Bentley and Cook intend to enroll 102 patients in the pivotal study. The primary safety endpoint is a composite measure of device technical success and procedural safety within 30 days. Likewise, the primary effectiveness endpoint is a composite measure of freedom from aneurysm-related mortality and freedom from clinically significant re-intervention through 12 months post procedure. A composite measure is a group of variables collected during the clinical study and analyzed.

“The ZFEN+ Endovascular Graft will meet a significant need for our patients. There are not many options to treat complex aortic aneurysms other than open repair or off-label use of devices. Even long after off-the-shelf devices become available, the ZFEN+ will offer a tailored approach specific to the patient anatomy. The ZFEN+ clinical study will provide a benchmark for safety and effectiveness of a less invasive option to treat complex abdominal aortic aneurysms,” said Dr. Gustavo Oderich, who is the Global Principal Investigator of the study.

Additional information about the clinical study is available at www.clinicaltrials.gov.

Contact: Matthias Bleesen, Communication & Event Coordinator, m.bleesen@bentley.global, +49 7471 984 995 631

LEIPZIG – 7^th June 2023, Bentley, a leading manufacturer of balloon expandable covered stents, announced at the annual LINC meeting in Leipzig, Germany, that it has reached an important milestone having sold the 300,000^th BeGraft. This milestone was celebrated appropriately at the Bentley booth at the Leipzig Interventional Course (LINC), which is taking place from 6 to 9 June 2023.

After launching the first BeGraft in 2012, the product found its way quickly to the clinics used in the most advanced and challenging endovascular procedures. The BeGraft is available in over 80 countries and became the market leader in most of them. With this steep growth Bentley is experiencing, the company proudly announced the sale of its 300,000^th BeGraft stent, which is a tremendous achievement.

Martijn Nugteren, Director Sales & Marketing at Bentley, is delighted with this six-figure number and mentioned in a statement “it is amazing what we have achieved with the BeGraft in such a short time, we were able to treat so many patients globally, giving them the best stent for the treatment of their vascular disease.” He also highlighted that “thanks to the acquisition of Qmedics in mid-April, Bentley is ready for the future growth of the BeGraft covered stent portfolio, which is much needed with the expected new indication and state of the art pipeline that we have.”

The 300,000^th BeGraft was sold to the company NovaHealth in Thailand, who is a proud partner of Bentley since 2015.

BePart of Bentley's exciting journey and upcoming milestones by following Bentley on LinkedIn. For product availability or further information, check www.bentley.global or send an email to info@bentley.global.

Contact: Matthias Bleesen, Communication & Event Coordinator, m.bleesen@bentley.global, +49 7471 984 995 631

Another milestone achieved – Bentley sold its 300,000th BeGraft

Hechingen, Germany, May 2023 – Bentley, a global leader in the endovascular treatment for aortic and peripheral vascular disease, announces their first product launch in the United States with the BeBack crossing catheter designed for the treatment of heavily calcified lesions.

After the acquisition of the GoBack catheter back in September 2022, Bentley worked behind the scenes on the rebranding of the device from GoBack to BeBack, making sure the device can benefit from the Bentley corporate branding. Bringing the BeBack to the market marks an important milestone for the Germany-based company since this is the first product, which is launched for the US market.

The BeBack catheter is designed for steering through Chronic Total Occlusions (CTO) that often is the most challenging part when treating heavily calcified lesions. The catheter is available in an 80 and 120 cm catheter in both a 2.9F and 4F size. The device makes use of a steerable and in length adjustable Nitinol needle, which is used for crossing and targeted re-entry purposes. A radiopaque marker indicates the direction in which the curved needle, located near the tip of the catheter, protrudes. Multiple treatment options from antegrade, retrograde and crossover are possible with the BeBack crossing catheter for intraluminal and sub intimal approaches of stenotic or occluded lesions.

Dr. Beasley - vascular and interventional radiologist at Palm Vascular Centers Miami Beach, had the honor to use the first BeBack on US soil. “Now that the BeBack is available I use it more frequently compared to other re-entry devices that are available on the market. The unique features of the BeBack make the most complex lesions easy to cross, and therefore the device helps to reduce the procedure time,” Dr. Beasley said. “Reducing the procedure time is of huge benefit for both the clinical center, the physician and of course for the patients, who will benefits the most. This and the unique features makes the BeBack such a game changer for CTO procedures,” Dr. Beasley continued.

The BeBack crossing catheter is now commercially available nationwide. The device will be showcased and presented at several upcoming conferences both nationally and internationally.

The BeBack is CE marked and FDA cleared for commercial purposes.

For product availability and further information, check: www.bentley.global or send an email to: info@bentley.global.

Contact: Matthias Bleesen, Communication & Event Coordinator, M.Bleesen@bentley.globa

Bentley launched its first product in the United States

Recruitment is now complete with more than 100 patients as planned per protocol in the branched endovascular aortic aneurysm repair (BEVAR) study that uses Bentley's BeGraft peripheral PLUS balloon expandable covered stent (Bentley InnoMed, Hechingen, Germany) as a bridging stent in complex aortic aneurysms repairs.

Sebastian Büchert (CEO, Bentley) mentioned, “At Bentley we became aware that a significant share of the BeGraft peripheral PLUS is being used as a bridging stent for the treatment of thoracoabdominal aneurysms in BEVAR procedures. Since none of the available covered stents are holding this indication, Bentley aims to step up and bring this off-label application on-label.”

The study, which is led by Dr. Martin Austermann, Surgeon of Vascular Surgery at the St. Franziskus Hospital in Münster, Germany, is evaluating the safety and performance of the BeGraft peripheral PLUS as a bridging stent in BEVAR procedures. When successful, this would bring the on-label use in this indication a step closer.

Dr. Austermann explained: "In BEVAR interventions, bridging stents are not supported by the native vessel wall, so the risk of failure is high. Although we have not yet analysed study data, the BeGraft peripheral PLUS with its special design met the requirements of high radial force combined with flexibility quite well. At first glance the data is promising, and with the potential indication for on-label usage as a bridging stent in BEVAR procedures, it will change the approach from the physicians' perspective."

The study endpoints include technical success of the procedure and patency of the bridging stent after one year. Safety will be evaluated for the one-year time point and will include the absence of procedure related complications and endoleaks associated with the bridging stents. Results are expected in the second half of 2024.

The study is a collaboration between the Foundation for Cardiovascular Research and Education (FCRE, Belgium) and Bentley. It has been approved by the German competent authority BfArM. Participating German centres are the St. Franziskus Hospital Münster, University Hospitals Aachen, University Clinic Hamburg-Eppendorf, LMU Munich, University Clinic Regensburg, Stuttgart Hospital, University Hospital Leipzig, University Hospital Heidelberg, University Hospital Schleswig-Holstein-Kiel and the Nuremberg Hospital.
 

ClinicalTrials.gov Identifier: NCT03982940

Contact: Matthias Bleesen, Communication & Event Coordinator, m.bleesen@bentley.global, +49 7471 984 995 631

Hechingen, January 2023 – Bentley, a global leader in the endovascular treatment for aortic and peripheral vascular disease, announces the launch of the BeBack crossing catheter designed for the treatment of heavily calcified lesions.

With the acquisition of the GoBack catheter in September 2022, Bentley marks a milestone in its young existence. Launched by Upstream Peripheral Technologies (Caesarea, Israel) in 2019, the device was available in 23 countries. Since the acquisition, the company managed to “re-brand” GoBack to BeBack, making sure that the device can benefit from the corporate branding and product synergies. It is Bentley’s intention to extend the global availability by its partner network to those countries that the company is already active in with its current product portfolio.

“Steering through Chronic Total Occlusions (CTO) is often the most challenging part when treating heavily calcified lesions,” said Martijn Nugteren – Director Sales & Marketing. “With the BeBack crossing catheter the physician has a great tool in hand to access and cross lesions to save limbs and reduce the number of amputations, thanks to the unique benefits of the device”.

The BeBack crossing catheter is available in an 80 and 120 cm catheter in both a 2.9 F and 4 F size. The device makes use of a steerable and in length adjustable Nitinol needle, which can be used for crossing and targeted re-entry purposes. A radiopaque marker indicates the direction in which the curved needle protrudes from the tip of the catheter. Multiple treatment options like antegrade, retrograde and crossover are possible with the BeBack crossing catheter for intraluminal and subintimal approaches of stenotic or occluded lesions.

The BeBack is CE marked and FDA cleared for commercial purposes.

Contact: Matthias Bleesen, Communication & Event Coordinator, m.bleesen@bentley.global, +49 7471 984 995 631

From left to right: Rainer Bregulla (Director R & D), Sebastian Büchert (CEO), Thomas Morawek (Arnold Schwarzenegger Impersonator), Hartmut Grathwohl (Director Operations), Andrew Brabner (Director Finance & IT),  Christian Bader (Director Quality & Market Access)

Spectacular operation at Hechingen-based medical technology company: 23.5-metre-long prestressed concrete bridge anchored

With a sensational operation, the Hechingen-based medical technology company Bentley set a milestone for its new building project in the Lotzenäcker industrial estate on Monday morning. In a tandem lift, two truck-mounted cranes (one weighing 500 tonnes, the other 250 tonnes) hoisted the prestressed concrete bridge that connects the existing Admin I building with the Admin II extension building into position.

The heavy-duty manoeuvre started at dawn, as another truck-mounted crane was already needed to erect the 500-tonne crane that had arrived from Offenburg in Baden. Shortly after 9 a.m., the 54-tonne and 23.57-metre-long footbridge was already suspended from four massive steel cables on which it was pulled up to a height of ten metres. Next up strength and precision work were combined: the floating walkway had to be fitted with centimetre precision into two meticulously prepared hatches in order to dock with the stairways of the two buildings. Just under an hour later, Thomas Silberberger, Project Manager at the construction company FBW Fertigbau Wochner from Dormettingen, announced that the project was completed: “Everything went exactly as planned.”

Among the many eyewitnesses of the spectacular manoeuvre was Bentley CEO Sebastian Büchert, who was not only pleased with the progress of construction but also emphasised how important the bridge construction was for the entire company. “For me”, says Büchert, “the bridge is also a symbol for the beginning of reuniting our employees after the pressures brought on by the pandemic”. In the near future the bridge will connect administrative offices and production areas, lead to the shared new canteen in the extension building and let people know that on the inside and outside: “We are Bentley”.

The 21.5-metre-high new Admin II building is scheduled for completion in summer 2023. So far, construction has mostly gone without delay. The short-term goal is to get the composite thermal insulation system onto the façade in time for winter. “We’re eagerly waiting to be able to move into the new building next year”, says the Managing Director of the dynamically expanding company. When the employees move in the building will already be 70 percent occupied. And since it’s important to be prepared for future growth, they’ve already started planning the next extension at the medium-sized world market leader in the field of innovative vascular implants – to perfect the bridge to the future.

Contact: Matthias Bleesen, Communication & Event Coordinator, m.bleesen@bentley.global, +49 7471 984 995 631

Drone shot of the nearly 24m long and 54 ton bridge being placed between the Bentley buildings Admin I and Admin II.

Bentley, a global leader in minimally invasive medical devices for vascular treatments based in the Medical Valley of Hechingen, has acquired the rights of the GoBack catheter from Upstream Peripheral Technologies (Caesarea, Israel).

This acquisition expands the company’s product portfolio, which is dedicated to improve the clinical outcomes of endovascular treatments, and because of this improving the patients’ quality of life.

“The acquisition of the GoBack catheter marks the start of inorganic growth for Bentley,” said Sebastian Büchert, Bentley's CEO. “We launched our first of six existing product families to the market in 2012 and have experienced significant growth since then. Now, only 10 years later we are able to acquire this very innovative product. This strategic move further completes our product offering to hospitals and physicians to the benefit of our joint patients.”

The GoBack catheter will simplify to “cross” and/or “re-entry” lesions in the arteries, which are for example occluded by heavily calcified plaque or stenosis. Its unique feature is a curved nickel-titan-alloy (nitinol) needle that can be manipulated by the physician using the device handle. Thanks to its small profile, the device can even be used in the smaller arteries in the lower leg.

“Bentley acquiring the GoBack makes me feel proud. I am sure that with Bentley’s global footprint more physicians will have access to the catheter,” said Dan Rottenberg, CEO of Upstream Peripheral Technologies. “Our vision is to save limbs and reduce the number of amputations. With Bentley’s strong network more patients will have access to such treatment.”

The GoBack catheter is CE marked and FDA cleared. The fact that the catheter also has FDA clearance will give Bentley the opportunity to explore the US market much quicker as initially planned. Launched in 2019, the device is now available in 23 countries. It is Bentley’s intention to extend the global availability to all of the 80 markets in which the company is already active.

Martijn Nugteren, Director Sales & Marketing, Bentley, says, “We will be really busy in the months ahead. Not only because we want to make the product commercially available in additional markets, but also due to the fact that we are going to rebrand the GoBack to BeBack. This is to make sure that our new product will be recognised as another leading product underneath Bentley’s brand umbrella.”

Currently produced in Israel and initially shipped from there, a production transfer to the Bentley production facility in Hechingen, Germany, will be completed by 2025.

For further information, check: www.bentley.global

About Bentley

Bentley was founded in 2009 by medical entrepreneurs Lars Sunnanväder and Miko Obradovic. The company has seen substantial growth since the launch of its first product in 2012, and today operates a global distribution network in more than 80 countries. The seven top-line products in Bentley’s portfolio are:

• BeGraft coronary (2012)
• BeGraft peripheral: 1st generation (2013); 2nd generation (2015)
• BeSmooth peripheral (2014)
• BeGraft aortic (2016)
• BeGraft PLUS (2017)
• BeYond (2020)
• GoBack/BeBack (2022)

About Upstream Peripheral Technologies

Upstream Peripheral Technologies is a privately held company, produces the GoBack Catheter to treat chronic total occlusions in angioplasty procedures. The company's mission is to ensure that no patient is left untreated, and has helped physicians save thousands of patients from unnecessary leg amputations.

Contact: Matthias Bleesen, Communication & Event Coordinator, m.bleesen@bentley.global, +49 7471 984 995 631

From left to right: Rainer Bregulla (Director R & D), Sebastian Büchert (CEO), Thomas Morawek (Arnold Schwarzenegger Impersonator), Hartmut Grathwohl (Director Operations), Andrew Brabner (Director Finance & IT),  Christian Bader (Director Quality & Market Access)

Recruitment is now complete with 100 patients planned per protocol in the fenestrated endovascular aortic aneurysm repair (FEVAR) study that uses Bentley's (Bentley InnoMed, Hechingen, Germany) BeGraft peripheral balloon expandable covered stent as a bridging stent in complex aortic aneurysms, bringing on-label use in this indication a step closer.

Led by Eric Verhoeven, Professor of Vascular Surgery at the General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany, the open label study is evaluating the safety and performance of the BeGraft stent as a bridging stent in FEVAR for complex aortic aneurysms.

To date, none of the commercially available covered stents are indicated as a dedicated bridging stent in FEVAR procedures.

“FEVAR is currently a well-established, minimally-invasive option for patients with abdominal aortic aneurysms and who are not eligible for an open aortic repair," said Sebastian Büchert (CEO, Bentley). He added, “the use of bridging stents has always been done off-label and we see it as our responsibility to get the BeGraft indicated for those procedures."

"We already know the patency is very good with the BeGraft as bridging stent, and we know how to handle this device," said Professor Verhoeven, who has used bridging stents for over 13 years at his Nuremberg clinic. He states, “although we have not yet analysed the data, I’m not expecting any surprises other than the confirmation that the Bentley BeGraft covered stents do well in this indication.”

The study's two performance endpoints comprise technical success of the procedure and bridging stent patency after one year. Safety will be evaluated for the one-year time point comprised of the absence of procedure related complications and bridging stent-related endoleaks. One-year results are expected during the second half of 2023.

Regarding the potential on-label approval of the BeGraft peripheral in this context, Professor Verhoeven said: "If you can use something on-label, many surgeons, particularly in relation to hospital policy, and in relation to the legal ramifications, would not, out of choice, use an off-label product."

The study is a collaboration between the Foundation for Cardiovascular Research and Education (FCRE, Belgium) and Bentley and is approved by the German competent authority BfArM. German participating centres are the University Hospitals Aachen, University Clinic of Gießen & Marburg, University Clinic Hamburg-Eppendorf, LMU Munich, University Clinic Regensburg, University Heart Center Freiburg-Bad Krozingen, St. Franziskus Hospital Münster, Stuttgart Hospital and Nuremberg Hospital.

ClinicalTrials.gov Identifier: NCT03987035

FCRE is also conducting a prospective, single arm, multi-centre clinical study in collaboration with Bentley to obtain an indication for the use of the BeGraft peripheral PLUS Stent Graft System as a bridging stent in branched endovascular aortic repair (BEVAR) for the treatment of complex thoraco-abdominal aortic aneurysms. This trial began in September 2020 and also aims to carry out 100 BEVAR procedures with an average of 2.5 bridging stents per procedure.

ClinicalTrials.gov Identifier: NCT03982940

Contact: Matthias Bleesen, Communication & Event Coordinator, m.bleesen@bentley.global, +49 7471 984 995 631

Although not without its challenges, medical technology company Bentley has had an extremely successful 2021. As in previous years, Bentley’s management and staff are equally keen to donate part of what they have earned together to a good cause.

CEO Sebastian Büchert kicked off this year’s fundraising campaign at the start of December in a hybrid information session for all Bentley employees. Büchert looked back on a second year in a row that had to be managed under more difficult conditions than usually, and expressed his thanks and respect to all employees for the way they had all worked together to keep Bentley on the path to success. A 25 percent increase in sales and the corresponding increase in profitability have allowed the company to pay out the highest employee bonus to date: a €4,250 bonus per person will be transferred along with the December salary.

“We all worked together to pull through,” Büchert said. “But we should not forget that having job security is anything but a given, especially during the pandemic. There are a lot of people much worse off than we are.” And it’s with this spirit that he called on all employees to participate in the fundraising campaign. This followed the same pattern as last year: overtime, days of holiday and monetary donations could be made on a voluntary basis. Each donated overtime hour was translated into €20 each, and for each full day of holiday €160 was donated. The sum of the donations, including the cash donations, was then doubled again by Bentley. 147 of the current 217 Bentley employees participated in this year’s campaign, donating a total of 823.5 hours of overtime, 567.8 hours of leave (which is equivalent to approximately 71 leave days) and €6,084 in cash, which ended up in a total of €67,821.20.

The recipient of the donations is once again the Förderverein für krebskranke Kinder Tübingen e.V., whose chairman Anton Hofmann was a guest at the pre-Christmas Bentley staff meeting this Wednesday (15 December) to receive the donation cheque. When handing over the cheque, Bentley CEO Sebastian Büchert said: “I am touched by the commitment and compassion of our employees. Once again, they have proven that they have a big heart for children and their families who are in a very difficult situation.”

Anton Hofmann expressed his sincere thanks and was overwhelmed by “how much Bentley and its employees have already done for us and our important work for children suffering from cancer”. The entire company displays “a great attitude” and has been supporting the Förderverein für krebskranke Kinder e.V. in an extraordinary way for years.

As Hofmann explained, the donations will be used for three permanent projects of the sponsoring association: the survivor consultation, in which children and adolescents recovering from cancer receive competent specialist medical help with late health effects even as adults; the project “Sports with Cancer”, which helps children during the illness and in the recovery phase to gain a new body awareness and new-found self-confidence; and the “Back to a New Life with Mental Strength” programme, which prepares children for embracing life after cancer.

The Bentley employees are convinced that their donations will be used in the right place. 

Contact: Kerstin Stotz, Communication & Event Coordinator, +49 7471 984 995 59, k.stotz@bentley.global

Mr. Büchert (right) presents the donation cheque to Mr. Hofmann (left)

On-label use of the Bentley (Bentley InnoMed, Hechingen, Germany) BeGraft peripheral balloon expandable covered stent in complex aortic aneurysms is a step closer with more than 50 patients now enrolled into the fenestrated endovascular aortic repair (FEVAR) study, which is designed to provide clinical evidence for on-label use in this indication.

The study aims to investigate the safety and performance of the BeGraft peripheral Stent Graft System as the dedicated bridging stent in FEVAR procedures for complex aortic aneurysms.

If data are forthcoming, Bentley aims to be the first company to apply for on-label approval of the BeGraft stent as a bridging stent in FEVAR, and shift from off-label to on-label use in complex aortic aneurysms.

Coordinating investigator and study lead, Professor Eric Verhoeven, Professor of Vascular Surgery at the General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany, remarked:

 “Recruitment has been excellent so far. Study investigators and patients have grasped the opportunity to help build an evidence base to support use of this intervention. To date, over 50 patients have been recruited from nine centres across Germany. If we continue at this pace, we are confident that we will complete patient enrolment in the first quarter of the coming year.” said Professor Verhoeven.

“The Bentley BeGraft stent fills an unmet medical need in the treatment of complex aortic aneurysms,” said Professor Verhoeven. “FEVAR is currently a well-established, minimally-invasive option for people with abdominal aortic aneurysms who are not eligible for a traditional endovascular aortic aneurysm repair (EVAR), but the usage of the bridging stents have always been done off-label in these procedures.” 

Christian Bader, Director of Quality & Market Access at Bentley is pleased about the speed of progress with patient recruitment for the study, and says: “We look forward to being able to offer an on-label solution for this important area of application after approval.”

Eventually, a complete cohort of 100 patients will be included to generate data on approximately 250-300 BeGrafts in fenestrations. Recruitment should be completed in the first quarter of 2022 with 24 months of follow-up.

Participating centres in the study include Nuremberg, Munster, Munich, Hamburg, Regensburg, Aachen, Stuttgart, Freiburg, and Giessen, all in Germany. To date, the majority of patients have been treated in Nuremberg by Professor Verhoeven, and by Professor Nikolaos Tsilimparis at Klinikum der Universität München (LMU).

The main outcomes will be technical success (successful introduction and deployment), bridging stent patency at 12 months, as well as the absence of procedure-related complications and bridging stent-related endoleaks at 12 months. Overall clinical outcomes including 30-day mortality, and health-related quality of life will also be assessed alongside adverse events.

The Foundation for Cardiovascular Research and Education (FCRE) is conducting the study, which is approved by the German competent authority BfArM, in collaboration with Bentley.

ClinicalTrials.gov Identifier: NCT03987035

FCRE is also conducting a prospective, single arm, multi-centre clinical study in collaboration with Bentley to obtain an indication for the use of the BeGraft peripheral PLUS Stent Graft System as a bridging stent in branched endovascular aortic repair (BEVAR) for the treatment of complex thoraco-abdominal aortic aneurysms. This trial began in September 2020 and also aims to carry out 100 BEVAR procedures with an average of 2.5 bridging stents per procedure.

ClinicalTrials.gov Identifier: NCT03982940

Never before in its 12-years history, a head of government was a guest at Bentley! On 23rd of September the Minister President from Baden-Württemberg*, Winfried Kretschmann, was warmly welcomed by CEO Sebastian Büchert and company founder Lars Sunnanväder at the Bentley headquarters in Hechingen.

However, since such a top politician does not have much time in the final phase of the election campaign, the programme of the visit had to be tightly pulled through in a little more than an hour. Sebastian Büchert presented the Bentley success story to Mr Kretschmann, who was accompanied by Chris Kühn, member of the Bundestag (the national parliament of the Federal Republic of Germany), and Cindy Holmberg, member of the Landtag (federal state parliament). Among other topics, the presentation also covered the "Großer Preis des Mittelstandes" award, which Bentley recently won (see press release of September 20th, 2021) as well as the new building plans at the site, which are to be implemented from October. The presentation of the award-winning corporate movie "For Peter", which shows that Bentley has the right stent for every patient, also highly impressed the visitors.

The politicians were also able to have a look how the Bentley products are manufactured during a 20-minute tour of the production facilities. "We are impressed," said Minister President Kretschmann afterwards. In the exchange that followed, the mayor of Hechingen Philipp Hahn said the city was "proud of medical technology companies like Bentley", which provide the city with a trade tax surplus worth millions. "We will invest this money in childcare and in new residential areas."

Of course, the meeting also dealt with topics that are of particular concern to Bentley and the medical technology industry in the region, for example the recruitment of skilled workers. Bentley CEO Sebastian Büchert presented a concept drafted by Bentley for a new apprenticeship as “medical technician" to Mr. Kretschmann and asked for political support in its implementation. The Minister President referred to the responsibility of the federal government, but assured support together with Chris Kühn by taking the initiative to Berlin to further discuss the proposal.

*third-largest state (Bundesland) in Southwest Germany in which Bentley is located

Contact: Kerstin Stotz, Communication & Event Coordinator, k.stotz@bentley.global

Lars Sunnanväder, Winfried Kretschmann, Sebastian Büchert, Cindy Holmberg, Chris Kühn & Philipp Hahn (from left to right)

The developer and manufacturer of innovative vascular implants wins the ‘Großer Preis des Mittelstandes’ (“Grand Prize for Medium-Sized Enterprises”) award

The German national daily newspaper “Die WELT” has described the ‘Großer Preis des Mittelstandes’ award, which is yearly assigned by the Leipzig-based Oskar Patzelt Foundation since 1994, as the “most coveted business award in Germany”. Bentley has now received the prestigious award after its second go. Last year the specialist for vascular implants had already been among the eight finalists, but now CEO Sebastian Büchert was able to receive the coveted award winner statuette on behalf of Bentley. Bentley came out on top among 931 participating medium-sized companies from all across Baden-Württemberg*.

“We are over the moon and proud to receive this award,” says Sebastian Büchert, who was accompanied by Product Development Manager Carmen Panero and his deputy Christian Bader, Director of Quality and Market Access. “This is an award for all Bentley employees who are responsible for the great success of our company.”

The challenging thing about the ‘Großer Preis des Mittelstandes’ is that a holistic approach is taken, rather than the participating companies having to prove themselves in one special field. There are five criteria evaluated by the judging panel: the overall development of the company, the creation and securing of jobs, innovation and modernisation, commitment to the region as well as customer focus, service and marketing.

Bentley was able to impress the judges in all these areas. In his award speech, Dr Helfried Schmidt, Chairman of the Oskar Patzelt Foundation which assigns the awards, praised the rapid growth and fast pace of innovation of the company. Bentley is committed to “making a difference in the care and health of patients with vascular diseases with first-class medical products”. After having launched its first implant for minimally invasive vascular surgery in 2012, Bentley now markets six product families of innovative implants developed and manufactured in-house. In his speech, Schmidt said that Bentley now “enjoys the esteem of vascular surgeons in more than 80 countries”.

Bentley’s rapid global growth can also be seen in the fact that the company will exceed the €50 million turnover mark for the first time in 2021 and now employs 210 persons, 185 of them at the Bentley headquarters in Hechingen. The judges considered it a huge success for Bentley that this growth has been financed from its own resources and that all start-up loans have already been repaid. The quality feature “Made in Germany” of all Bentley products was also emphasised. The entire expertise, from research to quality assurance, production to sales, administration and training, is concentrated at the company site in Hechingen, which will soon be expanded with the addition of a new administration building.

The local roots, however, go hand in hand with global networking. Among others Bentley is working together with Stanford University, Stuttgart University and internationally renowned vascular surgeons to develop implants.

In addition to the successes on the market, for which Bentley has also developed the world’s first ordering app for medical implants, the judging panel praised the corporate culture in particular. It is characterised by diversity and gender equality. The Bentley team is made up of more than 30 nationalities of all ages. The judges saw a gender balance across all levels of the company. Huge importance is attached to social skills, so that new colleagues feel comfortable in Bentley’s start-up mentality with its familiar and open atmosphere.

And then there’s the social responsibility lived out in the region. Since 2018, the company has been cooperating with the Förderverein für krebskranke Kinder Tübingen e. V. (Association for Children with Cancer), whose chairman Anton Hofmann was one of five people and organisations to nominate Bentley for the 2021 ‘Großer Preis des Mittelstandes’. The company was also nominated by one of the biggest local banks the Sparkasse Zollernalb, by the Mayor of Hechingen Philipp Hahn, by Dr Heiko Zimmermann, Managing Director of Medical Valley Hechingen e. V. (competence network of medical technology companies, its suppliers and service providers), and by Prof. Eric Verhoeven, Senior Physician of Vascular Surgery at Nuremberg Hospital.

Meanwhile, Bentley CEO Sebastian Büchert and his team are already looking to the future – not only to the new building in Hechingen, which should enable the company to double its turnover and workforce within the coming five years, but also to the National Gala for the ‘Großer Preis des Mittelstands’, which will take place in Dresden, Germany on 30th October, where the nationwide “special prizes” will be awarded among the winners.

* third-largest state (Bundesland) in Southwest Germany in which Bentley is located

Contact: Kerstin Stotz, Communication & Event Coordinator, k.stotz@bentley.global

Accepting the award on behalf of Bentley: CEO Sebastian Büchert (right), Christian Bader, Director of Quality and Market Access (left), and Carmen Panero, Product Development Manager (middle).

The manufacturer of minimally-invasive vascular prostheses is planning to expand its Hechingen site

By the end of 2026, Bentley plans to create 200 new jobs worldwide, most of them in Hechingen, Germany. This will double the company’s current workforce. The construction plans look impressive and are well thought out – Bentley is aiming high. After all, creating jobs for so many people requires space. Company founder and building owner Lars Sunnanväder is planning to put up a five-story building for his young, successful company. Bentley has only been around for 12 years, yet its products are already available in 80 countries worldwide – in some of them Bentley already became the market leader.

The company develops, manufactures and markets implants for the treatment of vascular diseases. These are, for example, stents covered with an ePTFE/Teflon tube that permanently widen constricted blood vessels or reliably cover weak points in the vessel wall. However, approvals that are essential for all medical devices are still missing for two of the most important markets: the USA and China. But these approvals are already in the pipeline, which is why Bentley needs to hire so many new employees. Managing Director Sebastian Büchert: “Although we’ve already created additional office space in our production hall, we’re just about to run out of room again. We’ve therefore rented additional office space in the building of a neighbouring company and set up office containers as well to accommodate all employees. But even these measures can only temporarily cover our continuously increasing space requirements.”

The basic principle for the new building, which will be built on the company’s previous parking lot, is ‘high is better than wide’. The plan is to build high, as further utilisation of green areas for flat new buildings would not be in keeping with the spirit of the times. The ground floor will house the finished goods warehouse, from where the products will be shipped all over the world. The upper levels will have a spacious canteen and three floors of offices for administration, regulatory affairs, marketing and sales. A suspended glass walkway will connect the old and new building. In addition, a photovoltaic system will be installed on the roof of the new building.

To ensure that the completion will be finished as planned in the second quarter of 2023, Bentley was approaching the city’s political bodies. There Managing Director Sebastian Büchert explained why Bentley is so keen to expand at the existing site. “For a medical technology company, a change of address is not a minor inconvenience of just ordering new stationery or business cards. In some countries we would have to go through parts of the approval process again, and Bentley would be unable to sell products in those countries for a year or two. Needless to say, this is a situation we want to avoid.”

Since private transport cannot be fully avoided in rural areas, the parking spaces eliminated by the new construction must be replaced. To this end, the medical technology manufacturer has acquired a neighbouring plot of land and, after demolishing the hall on it, will build a five-storey car park. This plan has already been put to the community. Charging stations for electric cars are also planned for the new car park. Completion of the 370 parking spaces is scheduled for the second quarter of 2022. Bentley is thus well equipped for further positive development – even beyond 2026.

Contact: Kerstin Stotz, Communication & Event Coordinator, +49 7471 984 995 59, k.stotz@bentley.global

HECHINGEN, GERMANY - The first patient to undergo fenestrated endovascular aortic repair (FEVAR) with the Bentley (Bentley InnoMed, Hechingen, Germany) BeGraft peripheral balloon expandable covered stent in the BeGraft FEVAR Study is being treated today.

The patient was referred for FEVAR with a 6 cm juxta-renal abdominal aortic aneurysm, explained the coordinating investigator and study lead, Professor Eric Verhoeven, professor of vascular surgery at the General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany. “This patient has an absolute indication due to the diameter and we cannot use standard EVAR to seal below the renal arteries because there is no sealing zone available.

A further two patients are planned in the next week, added Professor Verhoeven, pleased to announce the launch of the open-label BeGraft FEVAR study.

The study aims to investigate the safety and performance of the BeGraft peripheral Stent Graft System as a bridging stent in FEVAR for complex aortic aneurysms. The study, which is approved by the German competent authority BfArM, is being run in collaboration with Bentley and the Foundation for Cardiovascular Research and Education (FCRE).

Participating centres in the study include Nuremberg, Munster, Munich, Regensburg, Aachen, Stuttgart, and Giessen, all in Germany.

A total of 100 patients will be included to generate data on approximately 250-300 BeGrafts in fenestrations. Recruitment is deemed to take 12 months, with 24 months follow-up.

Main outcomes will be technical success (successful introduction and deployment), bridging stent patency at 12 months, as well as the absence of procedure-related complications and bridging stent-related endoleaks at 12 months. Overall clinical outcomes including 30-day mortality, and health-related quality of life will also be assessed alongside adverse events.

There are numerous covered stents on the market, including the BeGraft, all used off-label as bridging stents in FEVAR. However, there is a lack of consensus around what to use and there is no gold standard or solid evidence to support their use.

“Bentley is the first company to try to obtain an on-label approval for the BeGraft stent in FEVAR, and shift from off-label to on-label use,” remarked Professor Verhoeven.

In the meantime, FEVAR is a well-established, minimally-invasive option for people with abdominal aortic aneurysms who are not eligible for a traditional endovascular aneurysm repair (EVAR).These patients, who represent around 10% of all patients, usually have an aneurysm that is too close to the renal arteries, and until recently, they would require open surgery or no treatment at all. 

Open surgery is more invasive, and mortality is higher. In 2016, Professor Verhoeven published results of a study that showed mortality in patients who undergo FEVAR at his centre was 0.7%[1]. There is also a reduced duration of recovery in hospital with FEVAR compared to open surgery.

“For me, it’s clear that the BeGraft has an advantage as it goes into a 6F guiding sheath rather than a 7F sheath. The slightly lower profile is important, as a 6F guiding sheath tracks difficult anatomy better than a 7F. Also, the BeGraft comes in many lengths, and in short intervals, like a 27/28mm length, which is often ideal for more difficult renal arteries,” added Professor Verhoeven.

Bentley is also conducting a prospective, single arm, multi-centre clinical study to obtain an indication for the use of the BeGraft Peripheral Plus as a bridging stent in branched endovascular aortic repair (BEVAR) for the treatment of complex thoraco-abdominal aortic aneurysms. This trial began in September 2020 and aims to carry out 100 BEVAR procedures with an average of 2,5 bridging stents per procedure.

Initial results of the BeGraft in FEVAR trial should be available around mid-2023.

ClinicalTrials.gov Identifier: NCT03987035

[1] Verhoeven EL, Katsargyris A, Oikonomou K, et al. Fenestrated endovascular aortic aneurysm repair as a first line treatment option to treat short necked, juxtarenal and suprarenal aneurysms. Eur J Vasc Endovasc Surg 2016;51(6): 536-42.

Contact: Kerstin Stotz, Communication & Event Coordinator, k.stotz@bentley.global, +49747198499559

Professor Eric Verhoeven and his team at General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany after the first BeGraft implantation for the FEVAR clinical trial study

Having launched the BeYond Venous Self-Expanding Stent System to a selection of renowned venous centres in Europe in late 2020, Bentley announced the successful enrollment of the first patient in their Post-Market Clinical Follow-Up (PMCF) study this week.

Dr. Michael Lichtenberg, Karolinen-Hospital Arnsberg, Germany, is the coordinating investigator of this prospective, single arm, multi-centre PMCF study. Also involved are seven other leading venous centres across Europe: Houman Jalaie (RWTH Aachen, Germany), Rick de Graaf (Friedrichshafen Hospital, Germany), Christian Erbel (Heidelberg University Hospital, Germany), Oliver Schlager (Vienna University Hospital, Austria), Prakash Saha (Guy´s and St Thomas´, London, UK) and Gerry O´Sullivan (Galway, Ireland).

110 patients will be enrolled with a 24M follow-up to assess long-term safety and efficacy of the BeYond Venous in acute and chronic venous settings.

“With the BeYond Venous another promising device is available now in the growing field of venous interventions. The study aims to prove not only good patency results in the long-term, but also to gain evidence that this dedicated venous stent withstands all challenging venous pathologies,”, he mentions. “There is no ideal venous stent yet, but every new device is a complementary addition to what is already available and gives us as users even more options to treat every patient´s anatomy individually,” Lichtenberg added.

The BeYond Venous Self-Expanding Stent System is the first Nitinol stent in Bentley´s product portfolio, indicated for acute and chronic symptomatic obstructions of the femoral or iliac vein. It comes with a wide range of diameters from 10 mm to 18 mm and lengths up to 150 mm. With its optimized balance between radial force and flexibility, the BeYond Venous Self-Expanding Stent System allows accurate positioning and exact landing zones in venous interventions.

“We are looking forward to another great cooperation with regards to clinical evidence. It is Bentley´s aim to ground the clinical success of every product on a solid base of proven data,” states Dr. Martin Schirling, head of Clinical Affairs department at Bentley. “Nowadays, it´s essential to make a product reliable by showing favorable long-term results. This is where we put our focus on.”

Contact: Kerstin Stotz, Communication & Event Coordinator, k.stotz@bentley.global, +49747198499559

Zu Beginn des Jahres war wohl noch Niemandem bewusst, welche privaten und beruflichen Herausforderungen in diesem ungewöhnlichen Jahr bevorstehen würden. Auch für das Medizintechnikunternehmen Bentley und seine Angestellten waren und sind die Auswirkungen der COVID-19 Pandemie deutlich zu spüren. “Nur weil unsere Mitarbeiter alle getroffenen Schutzmaßnahmen stets unterstützt haben, konnten wir den Infektionsschutz wahren und gleichzeitig alle Betriebsabläufe aufrechterhalten.  Dass wir ihnen für ihre Unterstützung und ihr Durchhaltevermögen danken wollen, war eine einheitliche Entscheidung des Managements und unserer Gesellschafter.” so Sebastian Büchert, Geschäftsführer von Bentley.

Und so konnten sich die Mitarbeiter von Bentley Mitte November über ein überraschendes Vorweihnachtsgeschenk in Form eines steuerfreien Corona-Bonus in Höhe von 1.500€ freuen. Die erfreuliche Nachricht wurde in einer der regelmäßig stattfindenden hybriden Informationsveranstaltungen überbracht. In derselben Veranstaltung war außerdem Anton Hofmann, der Vorsitzende des Fördervereins für krebskranke Kinder Tübingen e.V. als Gast eingeladen. Denn bereits seit 2018 sammeln die Mitarbeiter von Bentley durch den Verkauf von Glühwein und Waffeln auf dem Hechinger Weihnachtsmarkt ehrenamtlich Spenden für den Förderverein.   In seinem Vortrag gab Herr Hofmann nicht nur einen Einblick in die Verwendung der Spendengelder, sondern machte auch auf die geringeren Spendeneinnahmen durch die Pandemie aufmerksam.

Da leider auch der Waffel- und Glühweinverkauf von Bentley dieses Jahr nicht stattfinden konnte, ist es umso bedeutungsvoller, was das Hechinger Unternehmen und seine Mitarbeiter wenige Wochen später gemeinsam bewirkt haben: Auf freiwilliger Basis konnten Überstunden, Urlaubstage und Geldbeträge gespendet werden. Wie in den vorigen Jahren wurden alle gespendeten Stunden von Bentley zu jeweils 20,00€ verrechnet und die Endsumme der Zuwendungen, inklusive der Geldspenden, dann von Bentley nochmals verdoppelt. Das Mitgefühl und Engagement der mittlerweile 200 Mitarbeiter war so groß, dass sich mehr als zwei Drittel der Belegschaft, darunter auch internationale Kollegen aus Frankreich, den Niederlanden, Großbritannien und Kolumbien, an der Spendenaktion beteiligten. Insgesamt kamen dabei mehr als 63 Urlaubstage, fast 600 Überstunden und 4.185,00€ in Form von Geldspenden zusammen. Alle Erwartungen wurden deutlich übertroffen, denn am Ende kam der äußerst erfreuliche Spendenbetrag von 52.238,00€ zusammen, womit der Spendenbetrag der Belegschaft aus dem Vorjahr mehr als verdoppelt werden konnte.

“Die Großzügigkeit unserer Mitarbeiter berührt mich sehr.  Denn auch wenn die Medizintechnikbranche wirtschaftlich weniger stark von der Pandemie getroffen wurde als andere, so musste doch jeder unserer Mitarbeiter Einschnitte im Privat- und Berufsleben hinnehmen. Umso schöner ist es, dass sie dennoch nicht vergessen, dass andere Menschen noch weitaus größere Sorgen haben.” so Büchert.

Die Mitarbeiter waren selbst überwältigt, dass sie einen Spendenbetrag in dieser Höhe zusammentragen konnten und freuen sich darüber, dass der Förderverein für krebskranke Kinder Tübingen e.V. mit dem gesammelten Geld viel Wertvolles für die erkrankten Kinder und deren Familien leisten kann.

Contact: Kerstin Stotz, Communication & Event Coordinator, +49 7471 984 995 59, k.stotz@bentley.global

Herr Anton Hofmann vom Förderverein für krebskranke Kinder Tübingen e.V., Frau Kirsten Laupp Personalleitung bei Bentley, Herr Sebastian Büchert Geschäftsführer von Bentley (v.l.n.r.)

Das Magazin FOCUS Business und das Arbeitgeberbewertungsportal kununu verleihen jährlich die Auszeichnung als FOCUS Top Arbeitgeber Mittelstand. Das Hechinger Medizintechnikunternehmen Bentley konnte sich diese Auszeichnung sichern.

Hinter kununu verbirgt sich die größte und bekannteste Arbeitgeber-Bewertungsplattform im deutschsprachigen Raum. Angestellte, Auszubildende und Bewerber haben die Möglichkeit Unternehmen in verschiedensten Bereichen zu bewerten und dabei ihre Eindrücke für Außenstehende transparent zu kommunizieren. Die Bewertungsskala reicht dabei von 0 bis 5 Sternen und wird ergänzt von einer prozentualen Weiterempfehlungsrate.

Gemeinsam mit dem Magazin FOCUS Business verleiht kununu jährlich die Auszeichnung als FOCUS Top Arbeitgeber Mittelstand. Analysiert werden dabei mehr als 950.000 Unternehmen und mehr als vier Millionen Bewertungen. Um sich für den Preis zu qualifizieren, darf der Bewertungsdurchschnitt des Unternehmens nicht unter 3,5 von 5 möglichen Sternen liegen und die Weiterempfehlungsrate muss mind. 70% betragen. Berücksichtigt werden dabei ausschließlich Unternehmen, die ihren Unternehmensstandort in Deutschland haben. Folgende Kriterien werden für die Bewertung herangezogen: Die Unternehmensgröße, die Punktzahl und die Anzahl der Bewertungen sowie die Rate der Weiterempfehlungen.

Mit einem Ranking von 4,5 von 5 möglichen Sternen und einer Weiterempfehlungsrate von sagenhaften 100%, konnte sich Bentley die Auszeichnung zum FOCUS Top Arbeitgeber Mittelstand sichern und seinen Ruf als beliebter Arbeitgeber in der Region weiter ausbauen. Auch wenn Bentley innerhalb des deutschlandweiten Rankings im Bereich Medizintechnik auf Platz vier landet, kann sich das Hechinger Unternehmen durchaus als Gewinner bezeichnen. Denn hinsichtlich der Unternehmensgröße Kategorie M (51-200 Mitarbeiter) sichert sich Bentley den ersten Platz und lässt die Konkurrenz hinter sich. 

Für das erst 2009 gegründete Unternehmen, welches zwischenzeitlich den Kinderschuhen entwachsen ist und sich zu einem etablierten Mittelstandsunternehmen entwickelt hat, ist das eine wichtige Auszeichnung. Denn mit Sitz in Hechingen befindet sich der Stenthersteller Tür an Tür mit vielen anderen erfolgreichen Medizintechnikunternehmen. “Auf Grund der ländlichen Lage und der Konkurrenz direkt vor der Haustür, ist es nicht immer einfach, geeignetes Personal zu gewinnen.  Wir sind davon überzeugt, dass diese Auszeichnung sowie die ungefilterten Einblicke für potentielle Bewerber sehr wertvoll sind, um sich ein erstes Bild vom Unternehmen zu machen. Oft kommen die kununu-Bewertungen schon im Vorstellungsgespräch zur Sprache. Ich stelle dabei fest, dass die Bewerber bereits im Vorfeld ein Gespür für unsere Unternehmenskultur entwickelt haben und eine Vorstellung davon haben, wie wir uns von anderen Unternehmen abheben”, so Kirsten Laupp, Personalleitung bei Bentley.  

Bentleys Unternehmenskultur zeichnet sich durch ein abteilungsübergreifendes Wir-Gefühl und Miteinander aus. Und trotz des starken Wachstums auf inzwischen knapp 200 Mitarbeiter ist es dem Stenthersteller gelungen, seine wertschätzende Unternehmenskultur beizubehalten. Wertschätzendes Verhalten bedeutet hier unter anderem, dass die Einschätzungen und Meinungen von Mitarbeitern erwünscht sind und aktiv eingefordert werden. Dass Arbeitgeber und Arbeitnehmer dies tatsächlich leben und sich gegenseitig respektieren, zeigt die kununu Weiterempfehlungsrate von 100%.

Die Auszeichnung als Top Arbeitgeber belegt, dass Bentley hier auf dem richtigen Weg ist und sie ist nicht die einzige Auszeichnung, die Bentley vom FOCUS Business Magazin in diesem Jahr erhält. Erst im Oktober konnte das Unternehmen die Auszeichnung als FOCUS Wachstumschampion 2021 entgegennehmen. Mit einem durchschnittlichen, jährlichen Wachstum von 44% (2016-2019), konnte das Unternehmen sein starkes, jährliches Wachstum der vorangegangen drei Jahre von 45% (2015-2018) nahezu unverändert fortsetzen. Bentley konnte sich damit, wie bereits im vergangenen Jahr, zu den am stärksten wachsenden Unternehmen Deutschlands zählen. Für das bevorstehende Wachstum sollen auch weiterhin Mitarbeiter gefunden werden, die nicht nur fachliches Know-How mitbringen, sondern auch menschlich gut zu Bentley passen. “Bentley hat auch in Zukunft noch viel vor. Dabei gehört es zu unseren Zielen weiterhin stark zu wachsen und den Standort in Hechingen kontinuierlich auszubauen. Ohne den engagierten Einsatz unserer Mitarbeiter und dem Zugewinn von qualifiziertem Personal ist das nicht möglich. Entsprechend legen wir großen Wert darauf, unseren Mitarbeitern ein attraktiver Arbeitsgeber zu sein." ergänzt Sebastian Büchert, Geschäftsführer von Bentley.

Contact: Kerstin Stotz, Communication & Event Coordinator, +49 7471 984 995 59, k.stotz@bentley.global

In its relatively young existence, Bentley has gained a good reputation within the endovascular society. With the introduction of the BeGraft family, Bentley made its entrance in the covered stenting market and offered new and unique features compared to the already existing products on the market.

Within the BeGraft portfolio, it is the BeGraft peripheral, which stands out and has the most impressive records of accomplishment. Not only because of its sizing range from 5 to 10 mm, but also in terms of the length of the stent. It was the BeGraft peripheral that first provided the vascular society with the much-needed missing stent length of approximately 28 mm. This, along with its flexibility and low profile, made the stent a "first to pick" for many physicians to improve the clinical outcome of their endovascular procedure.

As a result of its outstanding product characteristics, Bentley announces that early November they will achieve another milestone for the BeGraft peripheral stent: 100.000 sold products! “This is a great achievement for us,” says Sebastian Büchert, CEO at Bentley. ”We launched the product in October 2013 and in the beginning it started slowly like with any other product, but now the stent is known globally and accepted by the endovascular society thanks to its outstanding clinical track record. And that is not all, there is so much more to come for the BeGraft peripheral stent and the rest of the Bentley product portfolio,” he continues. 

Contact: Kerstin Stotz, Communication & Event Coordinator, +49 7471 984 995 59, k.stotz@bentley.global

The Baden-Württemberg-based company was a high flyer at Germany’s top business awards, the ‘Großer Preis des Mittelstandes’

With its ‘Made in Germany’ medical technology, the Hechingen-based company Bentley is held in high esteem by physicians around the world. So high, that the company, which was founded in 2009, was named a finalist in the prestigious ‘Großer Preis des Mittelstandes’, one of Germany’s top business awards. Bentley boasts a successful history of developing and manufacturing products, vascular implants for treating vascular constriction and aneurysms, which are available in over eighty countries.

The stent producer currently employs over 190 employees, and one of its strengths is the fact that it pools all its expertise at its Hechingen headquarters. In keeping with its motto of ‘Engineered and Manufactured in Germany’, all products are exclusively developed and produced in Germany – a quality feature that will continue to be strictly adhered also in the future. Bentley also places great emphasis on feedback from the doctors using its products, and considers this in its product developments. Nearly a third of its total workforce operates in the areas of product development, quality assurance and market access. ‘This is an exceptional figure, and one that is nearly twice as high as what you would find at other medical-technology companies. It lays the foundations for our fast product development and the speed at which we launch new products on the market’, says CEO Sebastian Büchert.

‘We are pleased to see Bentley named a finalist in the “Großer Preis des Mittelstandes”’, Büchert adds. ‘Because this award serves as recognition for every single Bentley employee, who all play a key role in the company’s success. For this reason, the wellbeing of our staff is also our top priority. If things are going well at an individual level, they will also go well at a broader company level.’ Bentley identified this early on, maintaining a flat hierarchy despite its rapid growth.

The HR department is constantly coming up with new ideas in keeping with the motto of BeBentley to encourage a positive working environment. Moreover, staff health is of great importance at Bentley: In addition to the option of leasing a bike, they also offer massages, free fruit, water, coffee and, as of recently, a partnership with a local gym. In-house information events are held regularly to promote exchange and cohesion among staff. They are continuing to run even during these times of the COVID-19 pandemic, with staff being kept informed of precautionary measures regularly and early on as part of online meetings.

‘It is a huge honour to be recognised at the “Großer Preis des Mittelstandes”, for which we have this year been nominated as a finalist for the first time. This drives us to keep going as we are, if not improving further’, says Christian Bader, Director Quality and Market Access. More than 4,970 companies across Germany have been nominated for the popular ‘Großer Preis des Mittelstandes’ award, with over 1,110 just from the federal state of Baden-Württemberg alone. What makes this award ceremony unique is the fact that only companies that have been nominated by other companies can participate.

The judges who nominate the companies make their decision based on the criteria of ‘overall business development’, ‘creating and securing jobs and apprenticeships’, ‘innovation and modernisation measures’, ‘involvement in the region’, and ‘service, customer focus and marketing’. Only eight companies from Baden-Württemberg were chosen as finalists by the panel of judges from the Oskar Patzelt Foundation this year. Fortunately, Bentley was one of them and was able to shine in all of these areas, and accept the honours at the awards ceremony in Würzburg.

Press enquiries: Kerstin Stotz, Communication & Event Coordinator, k.stotz@bentley.global, telephone +49 7471 98499559

Christian Bader, Director Quality and Market Access, and Carmen Panero, Product Development Manager
from Bentley at the award ceremony in Würzburg.

Last week, the first patient was recruited into a trial investigating the BeGraft Peripheral Plus Stent Graft System (Bentley InnoMed, Hechingen, Germany) as a dedicated bridging stent in BEVAR (branched endovascular aortic repair) for the treatment of complex aortic aneurysms. It is the first study of its kind worldwide.

Professor Martin Austermann, vascular surgeon at St. Franziskus Hospital, and Assistant Professor of Vascular Surgery, University of Münster, Germany, is the coordinating investigator of the prospective, single arm, multi-centre clinical study.

“Until now, we have not had a dedicated indicated bridging stent to connect branched endografts with renal and visceral arteries,” said Professor Austermann. “ There are many devices that could be used for this, but all in an off-label setting.”

“It’s great news that we could start a trial in collaboration with the Foundation for Cardiovascular Research and Education and Bentley for this indication, it has been an unmet need for such a long time,” he added. “We are very pleased to run this study, which is approved by the German national competent authority BfArM, together with some other colleagues working in high volume centres in Germany. For us, as endovascular specialists, it is key to work as much as possible with medical devices that are indicated for certain procedures.”

Eligible patients are those seeking elective repair of thoracoabdominal aortic aneurysm (TAAA) with BEVAR. The trial aims to carry out 100 BEVAR procedures with an average of 2,5 bridging stents per procedure.

The primary efficacy endpoint is comprised of a measure of technical success defined as the successfully introduction and deployment of the BeGraft Plus implanted as a bridging stent in BEVAR, with bridging stent patency at 12 months (absence of binary restenosis (≥50% stenosis)) or sole target vessel occlusion based on CT Angio at 12 months. The primary safety endpoint at 12 months relates to the absence of procedure-related complications and bridging stent related endoleaks.

“In one or two years the trial will provide us with valuable information on occlusions or stent fracture, for example. We will be able to let the patient know what to expect, and it will make the procedure more predictable,” Professor Austermann pointed out.

The BeGraft Plus uniquely combines an extraordinary radial force with a remarkable flexibility. It consists of two layers of micro-porous expanded polytetrafluoroethylene (ePTFE) tubing based on two cobalt chromium stents and has a ‘sandwich’ design. The outer ePTFE layer provides fixation of the outer stent and guarantees sealing properties. It also protects the inner ePTFE layer and prevents endoleaks. The inner PTFE layer provides a sealing of the aneurysm and the inner stent supplies fixation of the inner and outer ePTFE layer. Compared to the other available bridging stent grafts it has an up to 3.5 times higher radial force and is kink-resistant, making it an ideal bridging stent in BEVAR. 

“We believe that high-end medical technology is key to better patient care and health in vascular disease. This is Bentley´s vision and we always aim to prove the benefit of our products with clinical evidence,” said Dr. Martin Schirling, Clinical Affairs Manager, Bentley.

“Once again Bentley is pioneering the provision of safe and effective products to improve patient outcomes and to offer clinically proven solutions to our customers.”

Contact: Kerstin Stotz, Communication & Event Coordinator, k.stotz@bentley.global, +49747198499559

Bentley announces the receipt of the CE Mark for its BeYond venous Self-Expanding Stent System, launching it first for commercial sale and clinical use in Europe. The launch will be limited to an exclusive circle of leading venous experts to gain first-hand experience with this novel device. A full availability is expected for beginning of 2021.

The BeYond is an open-cell Nitinol stent, indicated for acute and chronic symptomatic obstructions of the femoral or iliac vein. It comes with a wide range of diameters from 10 to 18 mm and lengths up to 150 mm. With its optimized balance between radial force and flexibility, the BeYond allows accurate positioning and exact landing zones in venous interventions.

As a result of thrombosis, venous obstruction is a wide-spread disease. Together with heart attack and stroke, it is the leading cause of death in Western Europe. In Germany alone, more than 100.000 people die annually from the consequences of venous thrombosis. The endovascular therapy for venous disease has developed rapidly in the past few years, especially with the development of dedicated venous stent systems that meet the special requirements of the venous system.

“Although there are already products on the market that seem to be developed especially for veins, Bentley got the clinical feedback that these stents are not ideal yet – either they are too stiff or too flexible, both of which can reduce patient outcomes.” states Martijn Nugteren, Director Sales & Marketing at Bentley. “To overcome current shortcomings, we put the best of both worlds into the design of the BeYond venous.”

Venous stenting is proven to have a positive impact on the quality of life, especially of young and active people. The BeYond venous is designed to respect the natural venous anatomy to ensure the optimal balance between radial force, flexibility and deployment behaviour.

Contact: Kerstin Stotz, Communication & Event Coordinator, K.Stotz@bentley.global, +49 7471 984 995 59

First-in-Man of the BeYond Venous Stent performed in the European Venous Centre Aachen-Maastricht by Dr. Houman Jalaie, Mohammad Barbati, Dr. Long (China) & Philippe Charbonneau (Montréal/ Canada).

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Bloomington, Ind./Hechingen – Cook Medical and Bentley InnoMed GmbH today announced that they are collaborating in clinical trials involving Cook’s fenestrated and branch stent grafts and Bentley’s covered stents!

Right: Mark Breedlove, Vice President Vascular Division, Cook Medical

Left: Sebastian Büchert, CEO, Bentley

Bentley is marketing directly to its customers in France, moving from an agency arrangement to one with a dedicated team of seven sales representatives and a country sales manager, from January 1st, 2020.

Philippe Rozet, Country Sales Manager for France has 13 years of history working with balloon expandable covered stents in France. As well as Bentley’s range of peripheral covered stents, he will also oversee sales for the two other products in the portfolio: the BeGraft coronary stent and the BeSmooth peripheral stent (bare metal). Mr. Rozet is based in Paris and together with his team, he will nurture relationships with vascular surgeons, interventional radiologists, cardiologists, pharmacists and financial management within hospitals.

In France more than 600 physicians are active with endovascular procedures. “Our agents did a great job giving Bentley’s product portfolio a good footprint within the French market but their sales team still had to split their time and focus between the Bentley products and the other medical products they are distributing. I strongly believe that with a dedicated team we can increase our service and have more focus on the exclusive product portfolio that Bentley offers,” said Mr. Martijn Nugteren, Director of Sales and Marketing at Bentley.

“The French market has one of the highest penetrations of covered stent use in the world,” remarked Martijn Nugteren. “This is one reason why we decided to go direct to this market. With a dedicated sales force there will be a greater focus with 100% of representatives’ time spent on Bentley products,” he added.

Physicians are pushing the boundaries of clinical practice with Bentley stents, so the team in the field needs to have a significant amount of expert knowledge making sure that the best possible service can be provided, he added.

Mr. Rozet also commented on the new arrangement: “Bentley products are growing quickly in France and by going direct to our customers we intend to be more present in the market and optimise the level of supply and services”.

France is being added to a growing list of countries with dedicated sales teams as Bentley grows in size. These countries comprise Germany, the United Kingdom and the Netherlands. “It is always foremost in our minds to maximise the contact interface with physicians” said Mr. Nugteren.

Pleased to welcome Mr. Rozet to Bentley, Mr. Nugteren said: “I know Philippe from the previous company where we worked together on covered stents, Philippe has a huge network, is a very strong team builder with a positive drive, and is dedicated to ensuring that his team works optimally and build success for Bentley and the brand in France,” he added.

“I see this as a new and exciting challenge to build the Bentley brand by a direct approach” Mr. Rozet commented.  “With the team that we recruited I am more than positive that we will succeed and that we can show the society in France what we at Bentley have to offer.”

Contact:  Kerstin Stotz, Communication & Event Coordinator, K.Stotz@bentley.global, +49 7471 984 995 59

Last winter the Christmas market in Hechingen took place on the 3rd weekend of the Pre-Christmas season. Among all the colourfully decorated Christmas stands one was outstanding - the blue Bentley stand.

With joy, the Bentley employees voluntarily sold mulled wine, children's punch and waffles – and this was all for a good cause. Bentley did not only donate the proceeds, but the employees also made their contribution by donating their working hours. As in the previous year, the entire donation amount went to the Verein für krebskranke Kinder Tübingen e.V., which supports children with cancer as well as the families.

Thanks to a good suggestion from a Bentley employee, the fundraising campaign was extended to all other employees of the company. Everyone was able to donate part of his or her accumulated overtime hours or even vacation days on a voluntary basis. This summed up in more than hundred hours.

Inspired by the generosity of their own employees, the management decided to double the value of the donated hours. As a result, the donation was more than tripled compared to last year’s donation. At the end the amount rose to an impressive 21,888.68 €. On 20th of December, the donation cheque was handed over personally by the managing director Sebastian Büchert and Maria Linda Colucci, Assistant of Directors.

Knowing that the money will be used for a good cause, Bentley will certainly take part in the Christmas market again next year.

HECHINGEN – The success story continues. Following on from Bentley celebrating its tenth anniversary this summer, the company is now marking the next highlight in its short history – the Hechingen-based medical technology company has been named FOCUS Growth Champion 2020. Together with Statista, one of the world’s biggest online statistics platforms, the magazine FOCUS searched for the top 500 companies to have achieved a high percentage of sales growth between 2015 and 2018. Only companies with their headquarters in Germany were considered in the ranking.

The stent producer Bentley took first place in the area of electrical and medical technology. ‘We are delighted to be awarded as FOCUS Growth Champion 2020. Being such a young company, we are very proud to have received this award,’ says Sebastian Büchert, CEO of Bentley.

Bentley has developed rapidly since being founded by Lars Sunnanväder and Miko Obradovic in 2009. A key growth driver has been the fact that doctors and hospitals are becoming more and more technically skilled in the area of minimally invasive surgery, with the ever older patients then having a greater chance of recovery and survival with endovascular treatment than with conventional open surgery.

Bentley develops and produces its products exclusively in Germany – a quality hallmark that is to be retained in the future. To this day, the stent producer has successfully launched five products that are distributed in more than 70 countries around the world.

Bentley owes its strong growth not only to its innovative products and demographic developments, but also and above all to its committed and talented employees. ‘We already have a workforce of more than 160 and have evolved into an attractive employer in the region. The employee headcount has increased almost fourfold over the past three years. The large number of new employee hires has allowed us to handle the high demand for our products and further increase our sales growth,’ emphasises Büchert. A key cornerstone of this success has been last year’s inauguration of the new production facility together with an administrative building. The new site reflects the company’s growth and success and serves as home to all the corporate functions, from R&D, quality assurance and production to administration, customer service and training.

Strong growth offers a company a lot of opportunities, but also presents it with unforeseen challenges. ‘It is important to us that we remain transparent on all levels and promote interaction in spite of our growing structures, as this is and will continue to be Bentley’s greatest success factor.’ The medical technology company is fully aware that happy employees are the key to its success. Bentley therefore offers its staff various benefits such as annual profit participation, inter-company team events, regular excursions and health promotion measures such as a gym, free fruit and subsidised massages.

The company, which sees further growth opportunities in the years to come, intends to remain focused on the well-being of its employees in the future in order to further establish itself as an attractive employer within the region.

Contact: Kerstin Stotz, Communication & Event Coordinator, K.Stotz@bentley.global, +49 (0)7471 984 99559

HECHINGEN - Bentley, a global leader in the development of innovative treatments for vascular diseases, celebrated its tenth anniversary on June, 29th 2019.

It is a story of remarkable global expansion driven by a dedicated workforce and an innovative product base that has seen core endovascular staples, like the widely-used BeGraft peripheral stent, sit alongside niche products, notably the investigational BeGrow for treating newborns with pulmonary artery stenosis.

Started in 2009 by Lars Sunnanväder and Miko Obradovic, the company now has over 150 employees, and an enviable track record of product development and manufacture with five devices for endovascular intervention commercially available in over 70 countries.

Sunnanväder and Obradovic stepped away from operational roles last year, and now, together with other members, form the advisory board for Bentley InnoMed GmbH. Since this time, Sebastian Büchert, has been the Chief Executive Officer (CEO) of Bentley.

“Employees are the lifeblood of this company, and the growth we have witnessed is down to their commitment,” Büchert said. “In the past couple of months, the company has hired three to seven new people every month reflecting the exceptional growth of the company in recent years.”

In fact, 33% of the total workforce works in product development, quality assurance and market access. “This is extraordinarily high and nearly double what is seen in other medical device companies. This is the reason for our rapid product development and speed at which we bring products to market,” emphasised the CEO.

Asked what he believed had contributed to Bentley’s rapid and robust growth, Büchert highlighted, “Bentley managed to attract highly qualified and talented staff to quickly develop, reliably manufacture, and successfully market a broad and innovative line of covered stents for various vascular afflictions.”

“I’ve been in the medical device industry for 25 years, but I have never experienced the level of team spirit seen here at Bentley, he remarked, adding that, “It’s never about blame, it’s about finding solutions and improving things.”

BeGraft coronary was the first product, launched in 2012, and this was followed by BeGraft peripheral in November 2013.  It was at this point that revenues really started to build and the company took off. “Even today, BeGraft peripheral remains our core product,” explained Büchert.

Since then, Bentley has launched three further products, totaling five on the market: BeSmooth peripheral (2014); BeGraft aortic (2016); and BeGraft PLUS (2017).

Bentley is the only company worldwide that offers a covered balloon expandable stent in a size range from 2.5 mm to 30 mm in diameter. “We are very successful in the development of covered stents for peripheral vessels and this is where we see the core focus of our company in the future and where we wish to expand on a global scale,” said Büchert.

Increasingly, clinics are becoming technically competent in performing endovascular surgery, explained the CEO, and with an ageing population living with multiple co-morbidities, such patients are better suited to endovascular surgery as opposed to open surgery in terms of recovery and survival. “This, together with the outstanding clinical evidence for covered stents, are the main drivers for the market growth,” noted Büchert.

In April 2018, Bentley opened new state-of-the-art headquarters marking a major milestone in Bentley’s young history and reflect its rapid growth and success. The new base houses all of Bentley’s operations, from research and development (R&D), quality assurance and manufacturing, to administration, customer service and training.

The company also has a reputation for launching products in fast sequence and in the future, it wishes to continue to stay agile and efficient in its development process. “We will continue to launch new products and this will continue to drive growth of the company,” said Büchert.

Contact:  Kerstin Stotz, Communication & Event Coordinator, K.Stotz@bentley.global, +49 7471 984 995 59

New management for Bentley as current leaders adopt a role in the non-executive board

Both Lars Sunnanväder, existing Chief Executive Officer (CEO) of Bentley, and Miko Obradovic, existing Technical Director and Site Manager, will adopt new advisory roles in a senior management reshuffle
Sebastian Büchert takes over as Bentley CEO; Rainer Bregulla becomes Director Research & Development; and Hartmut Grathwohl adopts the role of Director of Operations.

November 12, 2018 - Lars Sunnanväder, existing Chief Executive Officer (CEO) of Bentley, and Miko Obradovic, existing Technical Director and Site Manager, announced today that adopting new advisory positions in the company. The changes come as Bentley moves into a new phase in recognition of a rapid and robust period of recent growth.

The changes are effective from today, and together with Annika Sunnannväder and Eurico Pacheco, Sunnanväder and Obradovic will form the executive advisory board for Bentley InnoMed GmbH, and will partially re-appoint the management and divisional management.

In an announcement to Bentley’s distribution partners and employees, Sunnanväder and Obradovic write that, “We have decided to move to a steering and advisory role and to place the operational responsibility for the company into trusted hands.”

Effective from today, Sebastian Büchert, the former Director of Sales & Marketing takes over the responsibility for the operational management of Bentley as CEO. Rainer Bregulla, will immediately adopt the position of Director Research & Development; and Hartmut Grathwohl, Bentley’s long-standing production manager, adopts the role of Director of Operations.

Sunnanväder and Obradovic were the founding members of Bentley nine years ago. They launched the company’s core product family known as BeGraft, the first product of which, the BeGraft coronary, was launched in 2012. BeGraft has been central to Bentley’s success over this time, with revenue and the number of employees having grown five-fold in the last four years alone.

Sebastian Büchert joined Bentley in November 2014, after starting his working life in Jostra AG in 1994. Jostra AG was the first of 12 companies that Sunnanväder founded. During his nine years there, he held various management positions in sales and marketing. After this Sebastian spent several different senior management roles in other companies before moving to Bentley.

Asked what he believed had contributed to Bentley’s rapid growth, Büchert said, “Bentley managed to attract highly qualified and talented staff to quickly develop, reliably manufacture and successfully market a broad and innovative line of covered and non covered stents for various vascular afflictions.”

Going forward, he highlighted that he wanted to further substantiate Bentley’s success and solid foundations, and secure the continuation of the company’s history of robust growth. “I want us to stay focused on the development of innovative products for endovascular challenges that doctors trust to improve both the clinical outcome and quality of life for the patient. Bentley shall also continue to be a company that employees enjoy working for.”

Bentley has undergone a lot of changes this year, with both a new head quarters and a state-of-the-art production facility, coupled with the significant growth in company turnover. As the new Director of Operations, Grathwohl commented on recent developments and how he planned to ensure a solid future for the company. “It has been an extraordinary year for Bentley with different operational challenges. We’ve managed to get through these with the team spirit of Bentley employees, and going forward we will continue to motivate the employees so they enjoy working for this great company,” he said. “The outlook is very good for operations, with the recent addition of people with extensive experience and talent in medical devices.”

As the company’s very first employee, Bregulla is stunned at how far Bentley has come in such a short time. “I never, in my wildest dreams, thought the company could achieve such success. It is partly scary, but also nice to see how fast Bentley it is growing, especially this past year.”

As new director of R&D, Bregulla says he will continue to work hard to ensure that they continue to bring highly innovative medical products to market in the near future, despite the increased regulatory requirements. “With this new role, I have the opportunity to use my experience in product development to best support Bentley in its global success.”

Contact: Martijn Nugteren, Director Sales & Marketing, M.Nugteren@bentley.global, +31 6 188 428 91

From left: Rainer Bregulla (Director R&D), Andrew Brabner (Director of Finance & IT), Christian Bader (Director Quality & Market Access), Hartmut Grathwohl (Director Operations), Sebastian Büchert (CEO) and Martijn Nugteren (Director Sales & Marketing)

Bentley is very happy to welcome the next member of the BeGraft family. The BeGraft Peripheral Plus is a covered, balloon expandable stent indicated for renal and iliac arteries. It uniquely combines an extraordinary radial force with a remarkable flexibility. Bentley is optimistic that the BeGraft Peripheral  Plus will perfectly complement its peripheral product portfolio and will  offer an additional option for doctors when choosing the best possible solution for their patients. For detailed information please access the product section.

Bentley Innomed has decided to market its products as Bentley in the future. The Bentley name better reflects the company’s maturing Corporate Identity and reinforces its strong-growing market position in the field of endovascular medical technology.

Keen to further improve the BeGraft Peripheral for its customers, Bentley implements the following design modifications for the full range.

Neither of these modifications have a negative affect on the valued features of the BeGraft Peripheral, such as its low profile (6F up to 8mm), flexibility, trackability and length control. Also, they entail no whatsoever impact on the safety and efficacy of the BeGraft Peripheral for its intended use.

The BeSmooth Peripheral Stent System is a balloon expandable cobalt-chrome-stent (CoCr) with superior features, similar to the already marketed BeGraft Peripheral. The BeSmooth excels with a high radial force while maintaining high flexibility and low profile. All available sizes (diameters 5.0 - 10.0mm) are 6F introducer sheath compatible. For detailed information access the product space. The BeSmooth line should make an important contribution to Bentley’s position in the global stent market. 

Bentley has received the CE-mark for additional stent sizes (diameters 4.5 and 5.0mm) of the BeGraft Coronary Stent Graft System. The extended product matrix enables care providers around the globe a more customizable patient treatment. 

Bentley expands its product portfolio with the BeGraft Peripheral Stent Graft System, a covered stent indicated for the intraluminal chronic placement in iliac and renal arteries. The single-layer cobalt chromium stent graft platform combines a low crimp profile with an extraordinary flexible design. Based on its unique nature, Bentley is optimistic that the BeGraft Peripheral has the potential to become the gold standard of covered stents. For detailed information access the product space. 

With the CE-mark for the BeGraft Coronary line, Bentley reaches new highs in product development. The intricate craftsmanship and innovative design make this new generation of covered stents particularly flexible, whilst guaranteeing an unprecedented low profile delivery (5F). For detailed information access the product space. 

Bentley InnoMed is proud to announce its DIN EN ISO 13485 certification. The company is now in the right to develop, manufacture and market medical products and accessories.