Abbot Submits Xience V Eluting Stent for Approval in Japan

Abbott (NYSE:ABT) 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 system in the primary endpoint of in-segment late loss at eight months. "Results of the SPIRIT III Japan Registry were very similar with those of the U.S. randomized clinical trial, which was the first head-to-head clinical trial to demonstrate the superiority of one drug eluting stent over another drug eluting stent," said Daniel Estay, divisional vice president, Abbott Vascular Asia Pacific and Japan. "XIENCE V represents an advancement in drug eluting stent science and reinforces Abbott's deep commitment to providing physicians and patients in Japan with leading technologies and products in cardiac and vascular care."