Japanese MHLW Approves Xience VEverolimus Eluting Coronary Stent System From Abbott

Published: 11-Jan-2010

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Abbott's Xience VEverolimus 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 authorisation.

The positive data for Xience V includes clinically superior long-term efficacy and safety results in the primary endpoints of the pivotal trials, and among the Spirit family of trials. The Spirit III Japan Registry of 88 patients demonstrated similar angiographic and clinical results to the outstanding outcomes from the Spirit III US trial.

Robert Hance, senior vice president of vascular at Abbott, said: "With today's approval, physicians in Japan will now have access to a 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.

"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. We look forward to making Xience V available to physicians in Japan shortly."

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