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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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