Edwards' mitral heart valve clears regulatory hurdle in China

11/30/2012 | MassDevice.com (Boston)

China's State Food and Drug Administration granted approval for Edwards Lifesciences to market its Carpentier-Edwards Perimount device, which offers a treatment option for patients in need of mitral heart valve replacement. The mitral valve, made from bovine pericardial tissue, already has been cleared in the U.S. and also has CE Mark approval in Europe.

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MassDevice.com (Boston)

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