Edwards Lifesciences Receives IDE for US Clinical Trial of Sapien 3

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Edwards Lifesciences Corporation
EW
, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of its Edwards SAPIEN 3 transcatheter aortic heart valve and accessories. The trial will study the SAPIEN 3 valve in the treatment of high-risk and inoperable patients with severe symptomatic aortic stenosis. It will enroll up to 500 patients treated with one of three delivery techniques: the transfemoral approach through an incision in the leg, the transapical route between the ribs or the transaortic approach through a small incision in the chest and aorta. Edwards anticipates that the trial will have a one-year composite endpoint compared to previous SAPIEN valves.
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