GORE’s VIABAHN® VBX Balloon Expandable Endoprosthesis Approved by FDA

W.L. Gore & Associates announced FDA approval of a lower profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft). This lower profile stent graft was designed in response to the need for smaller delivery systems; and is still used in the treatment of complex vascular disease.

According to Gore, the VBX stent graft now offers the “most 6 Fr compatible configurations among balloon expandable stent grafts.” No changes were made to the stent design to achieve the lower profile, allowing a 1 Fr reduction in the delivery system. Because of the versatility that a lower profile stent graft provides, it may be used in a more extensive set of patients with less complications and more ease of use. It will be introduced to the U.S. market in the coming months.

According to Jill Paine, Peripheral Business Leader for Gore’s Medical Products Division, “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.”