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FDA Approves Sapien Device Long after It Finds Approval in Europe

FDA recently approved the Sapien artificial heart valve from Edwards Lifesciences, which can be implanted without open-heart surgery. When inserted near the groin, the device can be threaded using a catheter into a major artery and eventually be positioned in the heart.

Read entire article: http://www.mddionline.com/blog/devicetalk/what-difference-four-years-makes-fda-clears-sapien-device-several-long-after-it-find

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