Gore Grabs FDA OK for Lower-Profile VBX Stent Graft

W.L. Gore & Associates (Gore) has obtained U.S. Food and Drug Administration (FDA) approval of a lower profile VIABAHN VBX balloon expandable endoprosthesis (VBX stent graft).
 
The company said the VBX stent graft is the longest balloon expandable stent on the market with a 79 mm configuration. Gore also said it has the widest range of stent diameter adjustability and offers the most 6 Fr compatible configurations among balloon expandable stent grafts.
 
No changes to the stent design occurred to achieve the lower profile, according to the company. Improvements were made to the delivery system only.
 
“The approval and release of the lower profile VBX Stent Graft serves as a demonstration of the Gore Medical Products Division’s commitment to continual improvement and lifelong innovation in collaboration with physicians to solve tough challenges where there is a critical patient need,” said Jill Paine, Peripheral Business Leader for Gore’s Medical Products Division. “We look forward to supporting our physicians and their patients through the delivery of this exciting innovation to their treatment toolbox.”
 
Since its launch in the U.S. in 2017, over 375,000 VBX stent grafts have been implanted globally. The device is indicated in the U.S. to treat de novo or restenotic lesions in iliac arteries with reference vessel diameters from five to 13 mm and lesion lengths up to 110 mm—including lesions at the aortic bifurcation.
 
“With the recently published five-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 (NCT05811364), 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,” said Ehrin Armstrong, MD, Interventional Cardiologist and Director of Clinical Research, Advanced Heart and Vein Center, Denver, Colo.