FLAGSTAFF, AZ (June 14, 2005) - W.L. Gore & Associates, Inc. (Gore), has received US Food and Drug Administration (FDA) approval to market the GORE VIABAHN® Endoprosthesis (6, 7, and 8 mm diameters) for use in the Superficial Femoral Artery (SFA). More than 30,000 GORE VIABAHN® Endoprostheses have been implanted since the product was introduced in 1997. The data provided to the FDA for this approval was based on a randomized multicenter trial comparing one year patency of percutaneous transluminal angioplasty (PTA) to the GORE VIABAHN® Endoprosthesis. Prior to receiving the SFA indication from the FDA, the device has been marketed in the US for the treatment of tracheo-bronchial strictures.
The GORE VIABAHN® Endoprosthesis is constructed with a durable, reinforced biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to the external nitinol stent structure. The self-expanding ePTFE/nitinol device is designed to allow relining of luminal surfaces in tortuous arterial anatomy.
The extreme flexibility of the GORE VIABAHN® Endoprosthesis enables it to better traverse tortuous areas such as the SFA and conform more closely to the complex anatomy of the artery. Along with its superior flexibility, the GORE VIABAHN® Endoprosthesis is engineered for exceptional strength and durability. This strength and durability makes it well suited to withstand the relentless forces and challenges of the SFA.
Radiopaque markers on the GORE SIM-PULL Deployment System enhance visualization to facilitate accurate stent-graft placement. The catheter-based system allows for rapid, accurate deployment without device lengthening or shortening.
"The FDA approval of the GORE VIABAHN® Endoprosthesis reinforces Gore's commitment to the patient and the medical community to provide leading-edge medical devices," said John Sininger, Medical Products Division Leader for Gore.
ABOUT W.L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 12 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac, general surgery and orthopedic procedures. Gore was recently named the second best company to work for by Fortune Magazine. The company's Medical Products Division will be celebrating its 30-year anniversary worldwide throughout 2005.
CONTACT
Customer Service
W. L. Gore & Associates, Inc.
800-528-8763
GORE, SIM-PULL, and VIABAHN® are trademarks of W. L. Gore & Associates.
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