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Abbott's XIENCE V gets MHLW approval

Singapore, Jan 11, 2009: Abbott announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. The company plans to launch XIENCE V in Japan in the upcoming weeks, immediately following final reimbursement authorization.

"With this approval, physicians in Japan will now have access to a next-generation drug eluting stent that offers outstanding ease of use and excellent clinical performance and safety. XIENCE V is the ideal combination as documented by the more than 16,000 patients who have been enrolled in the SPIRIT family of trials," said Robert Hance, senior vice president, vascular, Abbott.

"Each aspect of XIENCE V's design, from the thin struts to the flexible delivery system to the drug and polymer, was carefully engineered for optimal deliverability and to improve safety and efficacy outcomes for patients compared to earlier generation stents. These attributes have made XIENCE V the market-leading drug eluting stent around the world, and we look forward to making XIENCE V available to physicians in Japan shortly," he added.

"XIENCE V is flexible and easy to deliver through the coronary anatomy to the lesion site. These attributes combined with the strength of the safety and efficacy data supporting it give me confidence that XIENCE V is a true next-generation stent that has the potential to benefit heart patients in Japan," said Shigeru Saito, director, Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, and principal investigator for the SPIRIT III Japan Registry.

Abbott's XIENCE V is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure.

XIENCE V is built upon Abbott's bare metal stent, the MULTI-LINK VISION Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.

Japan is the second largest drug eluting stent market in the world after the United States, with approximately 200,000 stent procedures performed each year.

© BioSpectrum Bureau
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