Edwards Lifesciences has begun rolling out its Sapien 3 transcatheter aortic valve in the EU following the receipt of a CE mark, the Irvine, Calif.-based devicemaker said Monday. The company expects the launch of the next-generation Sapien to help it maintain a slight edge in marketshare over its main competition, Medtronic’s CoreValve.
According to Edwards, Sapien 3 is the only commercial transcatheter heart valve that can be placed through a low-profile 14 French expandable sheath. The device has an outer cuff of fabric, or “skirt,” surrounding the valve frame that protects against paravalvular leak. It can be implanted transapically, transfemorally or transaortically, anchoring in the aortic annulus, the company said.
Edwards expects to file a premarket approval application for Sapien 3 with the FDA by late 2014 or early 2015, with U.S. availability sometime in 2016. The device currently is being evaluated in a Phase III trial of 1,000 intermediate-riskpatients with a Society of Thoracic Surgeons score of four to eight percent. The company has also completed enrollment in a trial of high-risk patients with severe aortic stenosis. — Lena Freund
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