This article was originally published in The Gray Sheet
Executive SummaryPlans to submit an investigational device exemption for its mechanical heart valve to FDA next month, company President and CEO Manuel Villafana tells the Dain Bosworth Healthcare Conference Sept. 19. The valve, designed to reduce clotting in valve replacement surgery patients, received regulatory approval in France last week. Villafana says that France represents the largest market outside the U.S. for the valve, which currently is available commercially in the U.K., Spain, Belgium, and Australia and is awaiting approval in Italy and Japan
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