Abbott
Abbott Submits Application for Approval of XIENCE V Everolimus Eluting Coronary Stent System in Japan
Published in Medical Device Business Week, June 18th, 2008
Abbott (NYSE:ABT) announced that it has submitted an application for Seizo Hanbai Shonin (Marketing Authorization License) to Japan's Ministry of Health, Labour and Welfare (MHLW)/ Pharmaceuticals and Medical Devices Agency (PMDA) to gain approval for its XIENCE(TM) V Everolimus Eluting Coronary Stent System to treat coronary artery disease. The Shonin application for XIENCE V consisted of safety and efficacy data from the SPIRIT III clinical trial, including data from a Japanese patient population. As previously reported, results from the SPIRIT III U.S. pivotal clinical trial demonstrated the superiority of XIENCE V over Boston Scientific's TAXUS(R) paclitaxel-eluting coronary stent...
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