Edwards gets FDA approval to expand heart valve trial

By Elaine Rigoli

Tampa, Fla., May 30 - Edwards Lifesciences Corp. announced that, after completing 20 patient cases in a U.S. feasibility study evaluating the Cribier-Edwards percutaneous aortic heart valve, the Food and Drug Administration has approved expanding enrollment by an additional 35 patients.

The Cribier-Edwards percutaneous aortic heart valve is a balloon-mounted, compressed tissue heart valve that can be threaded through the patient's circulatory system from the leg directly over the aortic valve, according to a news release.

The non-randomized feasibility study began in January after Edwards received conditional approval from the FDA to proceed with its Investigational Device Exemption, the release said.

Based in Irvine, Calif., Edwards focuses on heart valve disease, peripheral vascular disease and critical care technologies.

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