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Medical Devices / Submissions and Approvals

Edwards Lifesciences Earns CE Mark for CENTERA Valve

Feb. 20, 2018
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Edwards Lifesciences received a CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.

The valve is repositionable and retrievable and can be delivered through a motorized delivery system.

The CE Mark was based on the trial results from a study of 203 high-risk patients at 23 centers in Europe, Australia and New Zealand.

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