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Abbott Submits Application for Approval of XIENCE(TM) V Everolimus Eluting Coronary Stent System in Japan
Date:6/2/2008

Japan Submission Includes Clinical Data Demonstrating Superiority of XIENCE

V Compared to TAXUS(R) Drug Eluting Stent

TOKYO, June 2 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today 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 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."

The XIENCE V stent utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is built upon Abbott's MULTI-LINK VISION(R) Coronary Stent System, the world's market-leading b
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SOURCE Abbott
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