Gore Viabahn VBX Earns Expanded Indication as a Bridging Stent in Europe

July 9, 2025—Gore & Associates announced CE Mark approval under the European Medical Device Regulation (EU MDR) for an expanded indication for the company’s Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) when used as a bridging stent with both branched and fenestrated aortic endografts in endovascular aneurysm repair (bEVAR and fEVAR, respectively) of aortic aneurysms involving the renal and mesenteric arteries.

Gore noted that the official launch of the VBX stent grafts with the new indication is planned for after summer during European and local congresses. Hospitals in Europe will begin implanting the newly indicated device in bEVAR and fEVAR procedures in the coming weeks.

As noted in the press release, Gore is conducting the EMBRACE and EXPAND registries to evaluate the VBX to expand indications as well as improve clinical practice and patient outcomes with the device. The multicenter, retrospective, and prospective EMBRACE registry evaluated the clinical performance and safety of the VBX device as a bridging stent. The study enrolled 259 patients treated with the VBX at 14 centers in Europe. Patients will be followed up to 5 years, stated Gore.

According to the company, findings from the EMBRACE registry included high rates of patency and freedom from endoleaks, target vessel instability, and reinterventions with the VBX stent graft in both bEVAR and fEVAR cohorts at 1 year. Professor Luca Bertoglio, MD, Associate Professor, Vascular Surgery, Spedali Civili Brescia in Brescia, Italy, serves as coordinating investigator of the EMBRACE registry.

“This is a landmark indication for a stent graft, equipping physicians with an on-label solution for more patients in complex pathologies,” commented Prof. Bertoglio in Gore’s press release. “We have studied performance in both fenestrated and branched cohorts, and the results demonstrate that we can safely and effectively treat these patients with the VBX device.”

The EXPAND registry’s principal investigator, Professor Mauro Gargiulo, MD, Chair of Metropolitan Unit of Vascular Surgery at IRCCS S. Orsola Hospital, University of Bologna in Bologna, Italy, added, “Physicians have waited some time for an approved bridging stent indication for fenestrated and branched repair. Having a CE-Marked indication is very important, as it is certainly of relevance to the endovascular community and the eligible patient population.

“I applaud Gore for recognizing the need for a CE Mark indication and for being committed to conducting such thorough and expertly run clinical studies like EXPAND and EMBRACE.”