FDA approves expanded Gore VIABAHN VBX use in FEVAR and BEVAR

W. L. Gore & Associates’ medical business announced U.S. Food and Drug Administration approval of an expanded indication for the GORE VIABAHN VBX Balloon Expandable Endoprosthesis. The announcement was reported by PR Newswire.

FDA action covers expanded use

According to PR Newswire, Gore said the FDA approved an expanded indication for the GORE VIABAHN VBX Balloon Expandable Endoprosthesis. Gore identified FEVAR and BEVAR as the settings for the expanded use.

The announcement identifies a regulatory action involving the VIABAHN VBX Balloon Expandable Endoprosthesis and its labeled use. PR Newswire reported the update as an FDA approval rather than a clearance.

What Gore announced

Gore described the action as approval for expanded use in FEVAR and BEVAR. The publisher named W. L. Gore & Associates’ medical business as the announcing organization and the U.S. Food and Drug Administration as the approving agency.

For medical-device sales professionals, the update provides a focused regulatory discussion point: an FDA-approved expanded indication for a named Gore endoprosthesis in the procedural settings cited by the company.

Announcement details

• Company: W. L. Gore & Associates’ medical business
• Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis
• Regulatory action: FDA approval of an expanded indication
• Settings named by Gore: FEVAR and BEVAR
• Publisher: PR Newswire

Industry context

The reported milestone centers on the scope of the device’s FDA-approved indication. Gore’s announcement specifically connects that expanded indication with FEVAR and BEVAR, while PR Newswire reports the company’s update.

Stakeholder conversations can remain anchored to the reported facts: the named device, the FDA approval, the expanded indication, and the FEVAR and BEVAR settings identified in Gore’s announcement.