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. (October 14, 2026) — 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