BeGraft - Model Coronary -Stent Graft System
This extraordinary product combines a highly flexible one-layer stent graft with a low-profile balloon catheter to offer an unrivalled small guiding catheter compatibility. The cobalt-chrome stent platform is covered with a micro-porous ePTFE membrane. The BeGraft Coronary Stent System is not for available in the US.
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.
The BeGraft Coronary Stent Graft System is not available in the US.
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.
For further information, please see the current version of the IFUs.