GORE Expands CE Mark Indication for VIABAHN Balloon Expandable Endoprosthesis as a Bridge Stent

GORE's New Milestone: Expanded Indication for VIABAHN® VBX Endoprosthesis

On July 9th, 2025, W. L. Gore & Associates made a significant announcement regarding the expanded approval of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. This device, now recognized with an expanded CE mark, serves a dual purpose. It can be utilized as a bridging stent in complex endovascular repairs involving branched and fenestrated aortic endografts, primarily focusing on aortic aneurysms that affect renal and mesenteric arteries.

Professor Luca Bertoglio, a prominent figure in vascular surgery and associate professor at Spedali Civili Brescia, has lauded this development, considering it a vital advancement in medical devices that enables physicians to provide suitable solutions for patients facing complex anatomical challenges. The study backing this approval included data from 259 patients, showcasing high patency rates and a notable absence of endoleaks, vessel instability, or the need for reinterventions after one year of treatment with the VBX Stent Graft (Gore's stent).

Bertoglio emphasized the extensive scope of the studies conducted across multiple European centers, which tested the VBX Stent Graft's performance and safety in fenestrated and branched cohorts. His sentiments were echoed by Professor Mauro Gargiulo, President of the Vascular Surgery Metropolitan Unit at IRCCS S. Orsola Hospital in Bologna. Gargiulo highlighted the particular importance of obtaining a CE-mark for bridging devices, which he believes is crucial for the endovascular community and eligible patient population.

In the coming weeks, hospitals are expected to start deploying the newly indicated VBX Stent Graft in procedures such as fenestrated endovascular aneurysm repair (fEVAR) and branched endovascular aneurysm repair (bEVAR). An official launch is anticipated post-summer when various European and local conferences are set to take place. The VBX Stent Graft is engineered to offer precise delivery while achieving positive outcomes across a range of complex applications. It boasts a unique technology derived from Gore's small-diameter endograft technology, with diameters ranging from 5 to 11 mm and lengths of 15, 19, 29, 39, 59, and 79 mm—making it the longest balloon-expandable endoprosthesis on the market.

Additionally, the device offers the most extensive diameter adjustment range available, allowing for a post-dilated maximum diameter of up to 16 mm with the 8L or 11 mm devices, catering to diverse therapeutic requirements. For further insights on the EMBRACE and EXPAND clinical studies, interested parties can find more information on clinicaltrials.gov.

The EMBRACE and EXPAND registries align with Gore's commitment to long-term assessments of device safety and usability, aiming to broaden indications, enhance clinical practices, and ultimately improve patient outcomes. This new phase in Gore's innovation journey is a testament to the company’s relentless pursuit of advanced endovascular treatment capabilities, built on years of close collaboration with medical professionals to tackle clinical and technical challenges associated with complex aortic repairs.

For more information about the VBX Stent Graft, visit goremedical.com/eu. Gore has established a solid reputation in the medical device industry, focusing on cardiovascular treatments and beyond, having implanted over 55 million devices globally in over 45 years, enriching patient outcomes through diligent research, quality initiatives, and education.

About Gore

W. L. Gore & Associates is renowned for its material science innovations aimed at transforming various industries. Since its inception in 1958, Gore has been committed to addressing intricate technical challenges in demanding environments, ranging from the cosmos to the human body, demonstrating a legacy of excellence in improving lives through collaborative solutions and innovations.