FDA approves expanded use of Gore VIABAHN VBX stent graft for complex aortic aneurysm repair
The FDA has approved expanded use of Gore's VIABAHN VBX Balloon Expandable Endoprosthesis as a bridging stent graft for complex endovascular aortic aneurysm repair.
The expanded indication permits use of the device in fenestrated and branched endovascular aortic repair, making it the first US on-label bridging stent option described for both FEVAR and BEVAR procedures.
Three-year EMBRACE Registry data reported vessel-level primary patency rates of 97.5% for FEVAR and 94.0% for BEVAR, supporting the device's clinical role in complex aortic interventions.
Field | Content |
Article Type | Approvals |
Device Name | Gore VIABAHN VBX Balloon Expandable Endoprosthesis |
Company | W. L. Gore & Associates |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | Expanded-use approval |
Device Type | Balloon-expandable covered stent graft |
New Clinical Application | Bridging stent graft for fenestrated and branched endovascular aortic repair |
Procedures | FEVAR; BEVAR |
Therapeutic Area | Vascular surgery; complex aortic aneurysm repair |
Clinical Evidence | EMBRACE Registry |
Three-Year Primary Patency in FEVAR | 97.5% at the vessel level |
Three-Year Primary Patency in BEVAR | 94.0% at the vessel level |
Approval Significance | Described as the first US on-label bridging stent option for both FEVAR and BEVAR |
Geography | United States |
What Happened | The FDA approved expanded use of Gore's VIABAHN VBX endoprosthesis as a bridging stent graft in FEVAR and BEVAR procedures. |
Why It Matters | The decision provides an on-label device option for complex aortic repairs involving fenestrated or branched endovascular techniques. |
Supporting Context | The EMBRACE Registry reported high vessel-level primary patency at three years in both FEVAR and BEVAR procedures. |
Potential Impact | The expanded indication may support broader clinical adoption and procedural standardisation in complex endovascular aortic repair. |
Key Takeaway | Gore's VIABAHN VBX has received an expanded FDA indication supported by three-year registry outcomes. |
What to Watch | Hospital adoption, longer-term vessel patency, device-related complications and future real-world clinical evidence. |
Primary Source | W. L. Gore & Associates announcement |
Relevant Date | 14 October 2026 |
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