FDA approves aortic stent graft from Gore for FEVAR and BEVAR
The U.S. Food and Drug Administration (FDA) has cleared a new indication for the Gore Viabahn VBX Balloon Expandable Endoprosthesis for fenestrated and branched endovascular aortic repair (FEVAR and BEVAR).
This is the first on-label device with a specific indication for bridging. Clinicians previously had to turn to the off-label use of other devices to perform these catheter-based procedures. The approval comes after new three-year outcomes from the EMBRACE Registry evaluated the real-world use of this device as a bridging stent in FEVAR and BEVAR procedures intended to repair complex aortic aneurysms.
“FEVAR and BEVAR have transformed the treatment of complex aortic aneurysms, allowing more patients to be treated with minimally invasive techniques," Gustavo Oderich MD, professor and chief of vascular and endovascular surgery at Baylor College of Medicine in Houston, said in a statement. "As these procedures have evolved, the need for a standardized, evidence-based approach to bridging stent use has become increasingly important."
He said having an FDA-approved bridging stent option specifically indicated for these procedures and supported by longer-term clinical evidence is an important advancement.
Gore was granted a European CE mark indication in 2025 for the on-label use of this device during FEVAR and BEVAR.
The three-year outcomes data presented at the 2026 European Society for Vascular Surgery meeting demonstrated safety and effectiveness in both FEVAR and BEVAR. The analysis included 103 patients and 208 target vessels treated with the VBX Stent Graft.
Overall, FEVAR results showed a 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. Three-year outcomes for BEVAR had a 94.0% vessel-level primary patency and 88.4% vessel-level freedom from TVI.
Since its U.S. launch in 2017, the company said more than 600,000 VBX Stent Grafts have been sold worldwide.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]