Gore Viabahn VBX Stent Graft Gains FDA Approval for Use in FEVAR and BEVAR

October 14, 2026—Gore & Associates announced FDA approval of an expanded indication for the company’s Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) for use in fenestrated and branched endovascular aortic repair (FEVAR and BEVAR).

The company advised that in FEVAR and BEVAR, the VBX stent graft serves as a bridge between the aortic endograft and the renal or mesenteric target arteries to help maintain vessel perfusion. The VBX stent graft was approved by the FDA in January 2017 for treatment of de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation.

Gore noted that the 3-year outcomes from the EMBRACE registry were presented at the European Society for Vascular Surgery’s annual meeting held October 6-9, 2026.

The multicenter EMBRACE registry evaluated real-world use of the VBX stent graft as a bridging stent in FEVAR and BEVAR among patients with complex aortic aneurysms. The 3-year outcomes demonstrated the device’s long-term safety and effectiveness in FEVAR and BEVAR, stated Gore.

The FEVAR analysis included 103 patients and 208 target vessels treated with the VBX stent graft. The 3-year outcomes included 97.5% vessel-level primary patency and 93.9% vessel-level freedom from target vessel instability (TVI).

The BEVAR analysis included 165 patients and 454 target vessels treated with the VBX stent graft. At 3 years, outcomes included 94.0% vessel-level primary patency and 88.4% vessel-level freedom from TVI.

“FEVAR and BEVAR have transformed the treatment of complex aortic aneurysms, allowing more patients to be treated with minimally invasive techniques,“ commented Gustavo Oderich, MD, in Gore’s press release. “As these procedures have evolved, the need for a standardized, evidence-based approach to bridging stent use has become increasingly important.”

Dr. Oderich, Professor and Chief of Vascular and Endovascular Surgery at Baylor College of Medicine in Houston, Texas, continued, “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.”

In July 2025, the Gore announced CE Mark approval under the European Medical Device Regulation for an expanded indication for the Viabahn VBX for BEVAR and FEVAR of aortic aneurysms involving the renal and mesenteric arteries.