The US Food and Drug Administration (FDA) has cleared Edwards Lifesciences’ Sapien transcatheter aortic heart valve, designed to treat inoperable patients with severe symptomatic aortic stenosis.
The Sapien valve, designed for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis, enables transcatheter aortic valve replacement, preventing the need for cardiopulmonary bypass.
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The approval follows the randomised controlled pivotal Partner trial, which evaluated the safety and effectiveness of the Sapien transcatheter valve.
The Partner trial also showed that patients receiving the Sapien valve experienced better quality of life as compared to patients in the control group.
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