Peripheral stent BeSmooth

cobalt-chromium

The BeSmooth Peripheral Stent System is indicated for the treatment of de novo or restenotic artherosclerotic lesions in protected peripheral arteries. MRI statements 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. In response to repeated requests from our clients, we used our experiences in the development of stent systems and came up with a highly flexible peripheral stent system, based on our peripheral stent graft system.