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Medical Devices / Submissions and Approvals

Edwards Lifesciences Gains CE Mark for Mitral Repair Device

Feb. 22, 2019

Edwards Lifescience gained the CE Mark for its Pascal transcatheter valve repair system for treating mitral regurgitation, the leakage of blood back through the mitral valve.

The device is designed to reduce mitral regurgitation, caused when the heart’s left ventricle contracts and the valve fails to close tightly.

The system uses two contoured, broad paddles to pull the valve’s two leaflets together, as well as a central spacer to fill the regurgitant orifice area.

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