Indication *:
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
* for full information, please see instruction for use
The BeGraft Aortic Stent Graft System is not available in the US.
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:
Under the scan conditions defined above, the “BeGraft Aortic Stent Graft” is expected to produce a maximum temperature rise of less than
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.
For further information, please see the current version of the IFUs.