Edwards Lifesciences has obtained approval from the FDA for its Inspiris Resilia bioprosthetic heart valve, a surgical prosthesis designed for use in future valve-in-valve procedures. The approval was backed by results from a 689-patient pivotal trial, which showed no cases of valve thrombosis, structural valve deterioration or nonstructural valve dysfunction associated with use of the device at two years.
FDA approves Edwards Lifesciences' bioprosthetic heart valve
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