Edwards gains CE mark for 29 mm aortic heart valve

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Edwards Lifesciences has received a CE mark for its 29 mm version of the Sapien XT transcatheter aortic heart valve, which will be made available with the company’s Ascendra transapical delivery system.

The valve will now be available in three sizes to serve a larger patient population and the device incorporates a tissue leaflet design and cobalt chromium frame to improve radial strength.

Sapien XT was commercially launched in Europe in 2010, but its efficacy and safety is still being studied in the U.S. within the PARTNER II randomized controlled trial.