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FDA approves Edwards Lifesciences' bioprosthetic heart valve

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.

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