Gore’s Viabahn VBX Stent Graft With Lower Profile Receives CE Mark Approval

January 13, 2025—Gore & Associates announced the recent CE Mark approval of a lower-profile Gore Viabahn VBX balloon expandable endoprosthesis (VBX stent graft). The lower-profile device will be rolled out to the European market over the coming months, advised the company.

Gore announced FDA approval of the lower-profile Viabahn VBX stent graft for treating complex vascular disease in January 2024.

With approval under that European Union Medical Device Regulation, the VBX stent graft features a 79-mm configuration, and a wide range of stent diameter adjustability with numerous 6-F compatible configurations, noted the company.

According to Gore, its improvements to the stent graft delivery system have enabled a 1-F profile reduction on the majority of sizes. The company noted that no changes to the stent graft design were made to achieve the lower profile. By focusing on improvements to the delivery system only, the characteristics and performance of the stent graft itself remain unchanged while the device’s versatility is enhanced by the lower profile.

“We are thankful to Gore for being able to be one of the first implanters of the new lower-profile VBX stent graft in Europe,” commented Professor Michele Antonello, MD, in the company’s press release. “Combined with the device flexibility, its accuracy and trusted performance, the new lower profile will enable me to treat my complex cases with a 6- or 7-F device.” Prof. Antonello is Director of the School of Specialization in Vascular Surgery of the University of Padua in Padua, Italy.

Ash Patel, MD, added, “With the recently published 5-year data and being part of the current Gore VBX FORWARD clinical study that aims to investigate the superiority of the VBX stent graft compared with bare metal stents for the treatment of complex iliac occlusive disease, this lower-profile innovation provides yet another reason to feel confident in the proven outcomes of the VBX stent graft and the broad applicability of its use in my practice.” Dr. Patel is a vascular surgeon at Guy’s & St. Thomas’ Hospital NHS Foundation Trust in London, United Kingdom.

The 5-year data from the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study evaluating the long-term treatment durability of the VBX stent graft in the treatment of patients with de novo or restenotic aortoiliac lesions were published by Andrew Holden, MD, et al in the February print issue of Journal of Endovascular Therapy (2025;32:68–76).

In the European Union, the VBX stent graft is indicated for the treatment of de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation; de novo or restenotic lesions in the visceral arteries; isolated visceral, iliac, and subclavian artery aneurysms; or traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral and pulmonary arteries), advised the Gore press release.