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Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis [Yahoo! Finance]

Edwards Lifesciences Corporation (EW)  More Company Research Source: Yahoo! Finance
Last edwards lifesciences corporation earnings: 4/23 04:15 pm Check Earnings Report
US:NYSE Investor Relations: ir.edwards.com
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 the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting' until symptoms develop," said Philippe Gen [Read more]
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Stockreport

Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis [Yahoo! Finance]

Edwards Lifesciences Corporation  (EW) 
More Company Research Source: Yahoo! Finance
Last edwards lifesciences corporation earnings: 4/23 04:15 pm Check Earnings Report
US:NYSE Investor Relations: ir.edwards.com
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 the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting' until symptoms develop," said Philippe Gen [Read more]
IMPACT SNAPSHOT
EVENT TIME:
EW
Last Price
Price Change
Price Change %
Volume Shares
Max Up
Max Down
Volume Ratio
%
Don't Miss Out On The Next BIG Stock Move
Performance comparison Updated
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
LAST PRICE AT
NEWS EVENT
SINCE EVENT
Multi-day stock performance from the time of the news release
LAST PRICE
VWAP
High:
MAX UP
High:
Low:
MAX DOWN
Low:
%
 POST NEWS RANGE
%
PRICE CHANGE
PRICE CHANGE PERCENTAGE
S&P 500 (SPX)
%
 VOLUME RATIO
%
VOLUME (SHARES)
TICKS
AVG SHARES PER TRADE
EVENT DAY
Event Day Chart will not be displayed beyond 90-day period of the event
PERFORMANCE SINCE EVENT
TIME AND VELOCITY ANALYSIS