Non-clinical testing has demonstrated that the “BeSmooth Peripheral Stent”, in single and in overlapped configuration up to app. 100 mm in length, is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

• static magnetic field of 1.5 Tesla or 3.0 Tesla, with
• maximum spatial field gradient of 3,900 G/cm (39 T/m)
• maximum force product of 71,000,000 G²/cm (71 T²/m)
• theoretically estimated maximum whole body averaged specific absorption rate (WBA-SAR) of < 2 W/kg for 15 minutes of continuous scanning
• normal operating mode of the MR system

This device shows a displacement force of 12 % and torque of 5 % and should not migrate in this MRI environment.

1.5 / 3.0 Tesla RF-induced heating in non-clinical testing in single and overlapped configuration up to 100 mm in length produced a maximum in-vitro temperature rise after 15 minutes of less than 7.7°C / 5.3°C when scaled to a WBA-SAR of 2 W/kg.

These calculations do not take into consideration the cooling effects of the blood flow.

MR-artifacts caused by the device (in-vitro) extend app. 31.0 mm from the stent when imaged with a spin echo pulse sequence and a 3 Tesla MR system.

For further information, please see the current version of the IFUs.