Gore’s Viabahn VBX Stent Graft With Lower Profile Gains FDA Approval

January 31, 2024—Gore & Associates, Inc. announced that the FDA approved a lower profile Viabahn VBX balloon expandable endoprosthesis for treating complex vascular disease.

Gore launched the Viabahn VBX in 2017. In the United States, the device is indicated for the treatment of de novo or restenotic lesions in iliac arteries with reference vessel diameters ranging from 5 to 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.

The lower profile device will be introduced to the United States market in the coming months. It is also being studied in the TAMBE trial of type 4 thoracoabdominal aortic aneurysms.

“Our team is pleased to be the first commercial implanter of the new lower profile VBX stent graft,” commented Darren Schneider, MD, in Gore’s press release. Dr. Schneider is Chief of Vascular Surgery and Endovascular Therapy at Penn Medicine in Philadelphia, Pennsylvania. He continued, “Combined with the flexibility, strength, and deployment accuracy I’ve always trusted with the device, the new lower profile will enable me to treat most of my complex cases with a 6- or 7-F device, reducing the risk of access complications while bringing trusted VBX stent graft outcomes to more of my patients.”

According to the company, improvements to the stent graft delivery system enabled a 1-F reduction of the profile on the majority of sizes. No changes were made to the stent design 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 and are joined by the enhanced versatility provided by a lower profile.

Depending on the practice, physicians may be able to use the VBX stent graft with a broader set of patients with a lower risk of complications at the access site, improved procedure efficiency, and an improvement in ease of use, noted Gore.

On January 16, 2024, Gore announced that the first patients have been enrolled in the Gore VBX FORWARD clinical study. In that announcement, the company noted that 5-year follow-up clinical data underscoring the long-term robustness and durability of the Viabahn VBX device to treat patients with iliac occlusive disease were published by Andrew Holden, MD, et al online in Journal of Endovascular Therapy in April 2023.

“With the recently published 5-year outcomes data, and the active pursuit of evaluating superiority versus bare metal stents in complex iliac occlusive disease through the Gore VBX FORWARD clinical study, this lower profile innovation gives me yet another reason to feel confident in the proven outcomes and broad versatility of this device in my practice,” stated Ehrin Armstrong, MD, in Gore’s press release. Dr. Armstrong is an interventional cardiologist and Director of Clinical Research at Advanced Heart and Vein Center in Denver, Colorado.