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www.fdanews.com/articles/73403-gore-receives-fda-approval-for-gore-viabahn-endoprosthesis

Gore Receives FDA Approval for Gore VIABAHN Endoprosthesis

June 16, 2005

Gore & Associates has received FDA approval to market the Gore VIABAHN Endoprosthesis (6, 7 and 8 mm diameters) for use in the superficial femoral artery. 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 to the Gore VIABAHN Endoprosthesis. Prior to receiving the SFA indication from the FDA, the device has been marketed in the U.S. for the treatment of tracheo-bronchial strictures.

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