Boston Scientific TAXUS V
This article was originally published in The Gray Sheet
Executive Summary
Paclitaxel-eluting stent clinical trial for 1,100 patients at 70 U.S. centers commences March 18. The study will evaluate the Taxus stent in patients considered to be at higher risk for restenosis than the 1,326 patients treated in TAXUS IV. On the same day, Boston Scientific submitted the second module of the device's PMA; the firm expects to file the fifth and final module in June and hopes for approval by year-end. FDA will prioritize review and approval of Taxus to provide competition for Johnson & Johnson/Cordis's Cypher, which is expected to be approved by the end of March (1"The Gray Sheet" March 17, 2002, In Brief)...