Gore Wins FDA Approval for VBX Stent Graft in FEVAR, BEVAR

FDA approval for VBX Stent Graft

Gore has won FDA approval for the VBX Stent Graft in fenestrated endovascular aortic repair and branched endovascular aortic repair, according to Medical Product Outsourcing.

Medical Product Outsourcing reported that the approval is an expanded indication for the device. The expanded indication covers use of the VBX Stent Graft as a bridging stent in fenestrated and branched aortic repair.

The reported approval applies to FEVAR and BEVAR, the acronyms used for fenestrated endovascular aortic repair and branched endovascular aortic repair.

Expanded indication in aortic repair

The FDA action identifies a bridging-stent use for the VBX Stent Graft within FEVAR and BEVAR procedures. Medical Product Outsourcing characterized the development as approval for an expanded indication.

For medical-device sales professionals following vascular-device regulatory developments, the update centers on the device, its approved role as a bridging stent, and the specified fenestrated and branched aortic repair settings.

Medical Product Outsourcing’s report provides the key scope of the approval: Gore’s VBX Stent Graft is approved for use as a bridging stent in FEVAR and BEVAR.

Key points reported by Medical Product Outsourcing

• Gore won FDA approval for the VBX Stent Graft.
• The approval covers an expanded indication.
• The indication covers use as a bridging stent.
• The specified settings are FEVAR and BEVAR.

What the report establishes

The reported regulatory event concerns the VBX Stent Graft and its use in fenestrated and branched aortic repair. Medical Product Outsourcing states that the expanded indication covers the device’s role as a bridging stent.

The approval therefore establishes a stated FDA-approved use for Gore’s device in the FEVAR and BEVAR settings described by Medical Product Outsourcing.