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Medical Devices / Submissions and Approvals

Edwards Lifesciences Gets FDA Nod for Inspiris Resilia Valve

July 10, 2017

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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