FDA APPROVES GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS FOR EXPANDED USE IN FEVAR AND BEVAR

Approval brings U.S. vascular surgeons the first on-label bridging stent graft for both fenestrated and branched endovascular aortic repair, as three-year clinical outcomes demonstrate safety and effectiveness.

FLAGSTAFF, Ariz., Oct. 14, 2026 /PRNewswire/ -- W. L. Gore & Associates' medical business (Gore) today announced U.S. Food and Drug Administration approval of an expanded indication for the GORE^® VIABAHN^® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) for use in fenestrated and branched endovascular aortic repair (FEVAR and BEVAR).

"This FDA approval is an important milestone for physicians treating patients with complex aortic aneurysms," said Jason Belzer, Gore Americas Business Leader. "We are proud to bring U.S. physicians an indicated bridging stent option for both FEVAR and BEVAR and to continue innovating to advance treatment options for patients with complex aortic disease."

The approval comes on the heels of newly released three-year outcomes from the EMBRACE Registry, unveiled at the European Society for Vascular Surgery's 40th annual meeting. The core lab-analyzed and multicenter designed registry evaluated real-world use of the device as a bridging stent in FEVAR and BEVAR among patients with complex aortic aneurysms.

"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 MD, 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."

Three-year outcomes demonstrate safety and effectiveness in FEVAR and BEVAR

The FEVAR analysis included 103 patients and 208 target vessels treated with the VBX Stent Graft. Three-year outcomes included:

• 97.5% vessel-level primary patency
• 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. Three-year outcomes included:

• 94.0% vessel-level primary patency
• 88.4% vessel-level freedom from TVI

The three-year findings build on previously presented one-year EMBRACE Registry outcomes and provide longer-term, core lab-adjudicated evidence of VBX Stent Graft performance in both FEVAR and BEVAR.

"Alongside the expanded U.S. indication for the VBX Stent Graft, these three-year EMBRACE Registry outcomes add important longer-term evidence in complex aortic care," said Matt Eggers, Gore Global Peripheral Business Leader. "We will continue sharing real-world results as follow-up progresses, giving physicians a clearer picture of the longer-term performance of the VBX Stent Graft in FEVAR and BEVAR."

U.S. vascular surgeons point to opportunities in complex aortic care

In a recent survey of U.S. vascular surgeons who perform complex aortic cases, reintervention rates, long-term durability and branch-vessel patency over time were the most frequently cited areas where clinical evidence for FEVAR and BEVAR could be improved.^[1]

The VBX Stent Graft is a balloon-expandable stent graft designed to provide flexibility, strength and deployment accuracy in complex endovascular procedures. Its design allows physicians to customize the device diameter and flare to meet procedural needs. In FEVAR and BEVAR, the VBX Stent Graft serves as a bridge between the aortic endograft and renal or mesenteric target arteries to help maintain vessel perfusion.

The U.S. approval builds on Gore's CE Mark indication granted in Europe in 2025, where the VBX Stent Graft is available for on-label use in FEVAR and BEVAR. Since its U.S. launch in 2017, more than 600,000 VBX Stent Grafts have been sold worldwide.

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 million medical devices implanted over the course of 50 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. goremedical.com

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With approximately 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5.3 billion. gore.com

Survey methodology: The Gore-commissioned survey was conducted from Aug. 28 to Sept. 5, 2026, among 46 U.S. vascular surgeons who perform complex aortic aneurysm procedures.

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. R_XOnly 

INDICATIONS FOR USE IN THE US: The GORE^® VIABAHN^® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm - 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.

The GORE^® VIABAHN^® VBX Balloon Expandable Endoprosthesis is indicated to maintain visceral artery perfusion as a bridging stent in:

• fenestrated endovascular aortic aneurysm repair with 6-8 mm diameter fenestrations
• branched endovascular aortic aneurysm repair with 6-8 mm diameter branches (e.g. portals, cuffs, or directional branches) that are at least 10 mm in length.

Bridging stent use is limited to aortic endovascular graft systems wherein safety and effectiveness has been demonstrated.

CONTRAINDICATIONS: Do not use the GORE^® VIABAHN^® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Patients with known sensitivities or allergies to the GORE^® VIABAHN^® VBX Balloon Expandable Endoprosthesis materials including expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), stainless steel, and heparin.

SOURCE W. L. Gore & Associates, Inc. MPD Division