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St. Jude Medical gains Japan valve system approvals

This article was originally published in The Gray Sheet

Executive Summary

Japan's Ministry of Health, Labor and Welfare announces regulatory and reimbursement approval for St. Jude Medical's Tailor flexible ring and flexible band for the repair of mitral and tricuspid valves. The company plans to begin immediately marketing both devices in Japan, where the valve repair market is growing around 20% annually, according to data cited by St. Jude. The ring and the band are designed to allow natural movement of the annulus and can be tailored to the patient. Both devices received 510(k) clearance in the United States in 2002



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