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

1. FDA approved Edwards Lifesciences' TAVR therapy for asymptomatic severe aortic stenosis patients. 2. This is the first approval of TAVR for asymptomatic patients, expanding potential market.

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FAQ

Why Very Bullish?

The FDA approval of TAVR for asymptomatic patients is a significant market expansion. Historical precedents show similar approvals led to stock price surges for medical device companies.

How important is it?

This FDA approval directly impacts Edwards Lifesciences' market potential and revenue. The significance of being the first in this niche suggests high investor interest and potential for stock appreciation.

Why Long Term?

The approval opens new patient demographics, likely increasing sales over the coming years. Previous product expansions in the medical field have shown sustained sales growth post-approval.

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IRVINE, Calif.--(BUSINESS WIRE)--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. Approval of the SAPIEN 3 platform (SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA) is based on groundbreaking data from the EARLY TAVR trial, wh.

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