Coronary arteries stent graft BeGraft

cobalt-chromiumePTFE

The BeGraft Coronary Stent Graft System is indicated for the treatment of acute coronary artery perforation and rupture, coronary artery aneurysm and coronary bypass-vein graft aneurysm. MRI statements Non-clinical testing has demonstrated that the “BeGraft Coronary Stent Graft” is MR Conditional. A patient with this device can be safely scanned immediately after implantation in an MR system meeting the following conditions: static magnetic field of 1.5 Tesla and 3 Tesla, with maximum spatial field gradient of 6,500 G/cm (65 T/m) maximum force product of 117,000,000 G²/cm (117 T²/m) theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR) of 2 W/kg (normal operating mode) Under the scan conditions defined above, the “BeGraft Coronary Stent Graft” is expected to produce a maximum temperature rise of less than 2.0°C (2 W/kg, 1.5 Tesla) RF-related temperature increase with a background temperature increase of ≈ 1.6°C (2 W/kg, 1.5 Tesla) 1.4°C (2 W/kg, 3 Tesla) RF-related temperature increase with a background temperature increase of ≈ 1.0°C (2 W/kg, 3 Tesla) after 15 minutes of continuous scanning. The effect of heating in the MRI environment for overlapping stent grafts or stent grafts with fractured struts is not known. In non-clinical testing, the image artifact caused by the device extends approximately 8.93 mm from the “BeGraft Coronary Stent Graft” when imaged with a spin echo pulse sequence and a 3 Tesla MR system.