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W. L. Gore & Associates, Inc. Receives U.S. Food & Drug Administration (FDA) Approval for Lower Profile Gore® Viabahn® VBX Balloon Expandable Endoprosthesis, Now 6 FR Sheath Compatible

With improvements to the stent graft delivery system enabling a 1 Fr profile reduction on the majority of sizes, the device now offers the most 6 Fr compatible configurations among balloon expandable stent grafts.

FLAGSTAFF, Ariz., Jan. 31, 2024 /PRNewswire/ — As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W. L. Gore & Associates, Inc. (Gore) announced recent FDA approval of a lower profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft).

GORE(R) VIABAHN(R) VBX Balloon Expandable Endoprosthesis

FDA approval of this innovation builds on a proven device which has become an important tool for treating complex vascular disease. In addition to offering the longest balloon expandable stent on the market with its 79 mm configuration, and the widest range of stent diameter adjustability, the VBX Stent Graft now also offers the most 6 Fr compatible configurations among balloon expandable stent grafts. 1-3

“Our team is pleased to be the first commercial implanter of the new lower profile VBX Stent Graft,” said Darren Schneider, M.D., Chief of Vascular Surgery and Endovascular Therapy, Penn Medicine, Philadelphia, Pennsylvania. “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 Fr device, reducing the risk of access complications while bringing trusted VBX Stent Graft outcomes to more of my patients.”

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, find improved procedure efficiency and/or a general improvement in ease of use.

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