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.