Gore has announced recent Food and Drug Administration (FDA) approval of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) for the treatment of complex iliac occlusive disease.
“Our team is pleased to be the first commercial implanter of the new lower profile VBX stent graft,” said Darren Schneider, MD, chief of vascular surgery and endovascular therapy at Penn Medicine in Philadelphia. “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 7F device, reducing the risk of access complications while bringing trusted VBX stent graft outcomes to more of my patients.”
Gore details in a press release that no changes to the stent design were made to achieve the lower profile. “By focusing on improvements to the delivery system only, the valued characteristics and trusted performance of the stent graft itself remain unchanged and are joined by the enhanced versatility a lower profile provides. Depending on the practice, physicians may be able to use the VBX stent graft with a broader set of patients, experience a lower risk of complications at the access site,” the company explains.
The lower profile device will be rolled out to the U.S. market over the coming months and is also being studied in the TAMBE trial of type 4 thoracoabdominal aortic aneurysms (TAAAs).
In January, Gore has announced that the first patients had been enrolled in the Gore VBX FORWARD clinical study, a global prospective, multicenter, randomized controlled trial to compare the Gore Viabahn VBX balloon expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease.
