FDA Approval Expands Bridging Stent Use in Complex Aortic Aneurysm Repair

These complex procedures have highlighted the need for stronger evidence and standardized, on-label options. An expanded U.S. indication now provides the first on-label bridging stent graft for both procedures, supported by three-year outcomes.

W. L. Gore & Associates has received U.S. Food and Drug Administration (FDA) approval of an expanded indication for the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) for use as a bridging stent in fenestrated and branched endovascular aortic aneurysm repair (FEVAR and BEVAR). The action, announced October 14, 2026, makes the device the first on‑label bridging stent graft in the United States for both procedures. The announcement coincides with newly reported three‑year outcomes in complex aortic aneurysm repair.

The VBX Stent Graft is a balloon‑expandable stent graft designed to provide flexibility, strength, and deployment accuracy in complex endovascular procedures. Its design enables physicians to customize device diameter and flare to procedural needs. In FEVAR and BEVAR, it bridges the aortic endograft to renal or mesenteric target arteries to maintain perfusion.

In the U.S., the device is now indicated to maintain visceral artery perfusion as a bridging stent in fenestrated repair with 6–8 mm diameter fenestrations and in branched repair with 6–8 mm diameter branches that are at least 10 mm long; bridging use is limited to aortic endovascular graft systems with demonstrated safety and effectiveness. It also retains its indication for de novo or restenotic iliac artery lesions in reference vessel diameters of 5–13 mm and lesion lengths up to 110 mm, including the aortic bifurcation. Contraindications include hypersensitivity to heparin and allergies to device materials such as expanded polytetrafluoroethylene, fluorinated ethylene propylene, stainless steel, and heparin.

The core lab‑analyzed, multicenter EMBRACE Registry evaluated real‑world bridging stent use in complex aortic aneurysms. In the fenestrated cohort (103 patients; 208 target vessels), three‑year vessel‑level primary patency was 97.5% with 93.9% freedom from target vessel instability. In the branched cohort (165 patients; 454 target vessels), three‑year vessel‑level primary patency was 94.0% with 88.4% freedom from target vessel instability.

The three‑year findings build on previously presented one‑year outcomes and provide longer‑term evidence of performance in both FEVAR and BEVAR. A European CE Mark indication for on‑label use in FEVAR and BEVAR was granted in 2025. A recent survey of U.S. vascular surgeons performing complex aortic cases highlighted reintervention rates, long‑term durability, and branch‑vessel patency as priority evidence needs.

“FEVAR and BEVAR have transformed the treatment of complex aortic aneurysms, allowing more patients to be treated with minimally invasive techniques. As these procedures have evolved, the need for a standardized, evidence‑based approach to bridging stent use has become increasingly important,” said Gustavo Oderich M.D., Professor and Chief of Vascular and Endovascular Surgery at Baylor College of Medicine in Houston, TX. “Having an FDA-approved bridging stent option specifically indicated for these procedures and backed by longer-term clinical evidence is an important advancement for physicians treating these challenging cases and, ultimately, for the patients who may benefit from these procedures.”

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