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  • FDA Approves TAVR in Low-Risk Patients

    The U.S. Food and Drug Administration (FDA) has approved transcatheter aortic valve replacement (TAVR) for patients with severe symptomatic aortic stenosis who are at low risk for surgical mortality. Medtronic (Dublin, Ireland) announced the approval in a news release featuring its Evolut TAVR system. The FDA updated its overview webpage on the Edwards Sapien 3 and Edwards Sapien 3 Ultra Transcatheter Heart Valve System (Edwards Lifesciences, Irvine, California) to show that it was approved Friday.

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