FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Edwards Lifesciences’ Heart Valve Approved

Jan. 4, 2019
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The FDA has given its approval for Edwards Lifesciences’ SAPIEN 3 Ultra, a heart valve used in transcatheter aortic valve replacements.

The system is intended for severe, symptomatic aortic stenosis patients that have been found to be at intermediate or greater risk of needing open-heart surgery.

The valve includes technological enhancements and a new delivery system that builds on the previous SAPIEN 3 units.

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