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

Edwards Lifesciences Corporation (EW)  More Company Research Source: Business Wire
Last edwards lifesciences corporation earnings: 4/23 04:15 pm Check Earnings Report
US:NYSE Investor Relations: ir.edwards.com
Transforming Care for Severe AS Patients 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, which demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance (watchful waiting).Without treatment, 1 in 10 patients experiencing symptoms of severe AS may die within five weeks. However, the symptoms of severe AS can be difficult to detect and may progress rapidly and unpredictably.“There is an urgent need to change practice and TAVR guidelines for [Read more]
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Stockreport

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

Edwards Lifesciences Corporation  (EW) 
More Company Research Source: Business Wire
Last edwards lifesciences corporation earnings: 4/23 04:15 pm Check Earnings Report
US:NYSE Investor Relations: ir.edwards.com
Transforming Care for Severe AS Patients 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, which demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance (watchful waiting).Without treatment, 1 in 10 patients experiencing symptoms of severe AS may die within five weeks. However, the symptoms of severe AS can be difficult to detect and may progress rapidly and unpredictably.“There is an urgent need to change practice and TAVR guidelines for [Read more]
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EW
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LAST PRICE AT
NEWS EVENT
SINCE EVENT
Multi-day stock performance from the time of the news release
LAST PRICE
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Low:
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Low:
%
 POST NEWS RANGE
%
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%
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%
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EVENT DAY
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PERFORMANCE SINCE EVENT
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