First Patient enrolled in the clinical study of Bentley’s BeGraft and Cook’s Zenith® Fenestrated+ Endovascular Graft

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

“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.