Edwards Lifesciences (EW) said Thursday that the US Food and Drug Administration approved its Sapien 3 transcatheter aortic valve replacement therapy, or TAVR, for asymptomatic patients with severe aortic stenosis.
The FDA approved the Sapien 3 platform, including Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia models, based on compelling results from the Early TAVR trial. The trial demonstrated better outcomes for asymptomatic severe aortic stenosis patients treated with Edwards' TAVR compared to those monitored under standard guidelines, the company said.
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