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Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis

IRVINE, Calif., May 01, 2025--Edwards Lifesciences (NYSE: EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients.

articleEdwards Lifesciences CorporationMay 1, 20254/company/edwards-lifesciences-corp/news/edwards-tavr-receives-fda-approval-120000246
Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis

About this update from Edwards Lifesciences Corporation

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Edwards LifesciencesTAVRSAPIENwatchful waitingasymptomatic patientsclinical surveillanceclinical outcomesLarry Woodforward-looking statements