BeGraft - Model Plus -Peripheral Stent Graft System

The BeGraft Peripheral PLUS Stent Graft System is indicated for intraluminal chronic placement in iliac and renal arteries for:

• Restoring and improving the patency
• Treating aneurysms, acute perforations, acute ruptures and fistulas

The BeGraft Peripheral PLUS Stent Graft System is not available in the US.

Non-clinical testing has demonstrated that the “BeGraft Peripheral Plus 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 5,700 G/cm (57 T/m)
• maximum force product of 102,000,000 G²/cm (102 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 Peripheral Plus Stent Graft” is expected to produce a maximum temperature rise of less than

• 2.9°C (2 W/kg, 1.5 Tesla) RF-related temperature increase with a background temperature increase of ≈ 1.5°C (2 W/kg, 1.5 Tesla)
• 2.1°C (2 W/kg, 3 Tesla) RF-related temperature increase with a background temperature increase of ≈ 0.9°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 14.6 mm from the “BeGraft Peripheral Plus Stent Graft” when imaged with a gradient echo pulse sequence and a 3 Tesla MR system.

For further information, please see the current version of the IFUs.