FDA approves Gore bridging stent graft for complex aortic repairs

MassDevice reports that the FDA has approved Gore’s Viabahn VBX endoprosthesis for use in complex aortic aneurysm repairs. The publication identifies the product as a bridging stent graft.

Approval includes FEVAR and BEVAR

According to MassDevice, the FDA greenlit the Viabahn VBX endoprosthesis for use in fenestrated and branched endovascular aortic repairs.

Fenestrated endovascular aortic repair is known as FEVAR, while branched endovascular aortic repair is known as BEVAR. MassDevice reported that the device may be used in both approaches.

The reported action concerns complex aortic aneurysms and places the Gore endoprosthesis in the bridging role described by MassDevice for these endovascular repair procedures.

Reported product and procedure context

MassDevice named Gore’s Viabahn VBX endoprosthesis as the device involved in the FDA action. The publisher characterized it as a bridging stent graft for complex aortic aneurysm repair.

The approval applies across the two named endovascular approaches: FEVAR and BEVAR. The report does not provide further details on procedural use, patient selection, clinical outcomes, or other product specifications.

For medical device professionals following vascular and aortic therapy developments, the update is a regulatory event involving Gore’s Viabahn VBX endoprosthesis and its stated use in fenestrated and branched endovascular aortic repairs.

Key details reported by MassDevice

• The FDA approved Gore’s Viabahn VBX endoprosthesis.
• MassDevice described the device as a bridging stent graft.
• The approval covers fenestrated endovascular aortic repair, or FEVAR.
• The approval also covers branched endovascular aortic repair, or BEVAR.
• MassDevice linked the approval to complex aortic aneurysm repairs.

Source: MassDevice.