Iliac artery stent graft BeGraft

abdominal aortacobalt-chromiumePTFE

The BeGraft Aortic Stent Graft System is indicated for: the implantation in the native and / or recurrent coarctation of the aorta (CoA) on adolescent or adult patients restoring and improving the patency of the iliac arteries MRI statements Non-clinical testing has demonstrated that the “BeGraft Aortic 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 3,400 G/cm (34 T/m) maximum force product of 62,000,000 G²/cm (62 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 Aortic Stent Graft” is expected to produce a maximum temperature rise of less than 3.1°C (2 W/kg, 1.5 Tesla) RF-related temperature increase with a background temperature increase of ≈ 1.3°C (2 W/kg, 1.5 Tesla) 2.9°C (2 W/kg, 3 Tesla) RF-related temperature increase with a background temperature increase of ≈ 0.8°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 18.5 mm from the “BeGraft Aortic Stent Graft” when imaged with a spin echo pulse sequence and a 3 Tesla MR system.