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Medical Devices / Submissions and Approvals

Edwards Lifescience’s Rapid Deployment Valve Receives FDA Approval

Aug. 16, 2016

The FDA has granted approval of Edwards Lifescience’s advanced Edwards Intuity Elite valve system, a rapid deployment device for surgical aortic valve replacement.

The approval was supported by data from the clinical trial that treated 839 patients in 29 centers in the U.S.

The device was approved for commercial sale in Europe in 2014. — Cynthia Jessup

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