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Medical Devices / Submissions and Approvals

Edwards Lifesciences Gets FDA Nod for Inspiris Resilia Valve

July 10, 2017
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The FDA has approved Edwards Lifesciences’ new Inspiris Resilia aortic valve.

The approval for the valve follows a pivotal trial in which two-year data from nearly 700 patients showed no indications of valve thrombosis, nonstructural valve dysfunction or structural valve deterioration. The valve uses technology designed for potential valve-in-valve procedures.

The company expects to market the device on the U.S. early next year. It is already available in Europe and a launch is planned later this year in Japan.

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