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Abbott says FDA approved heart valve medical device

Friday, 25 Oct 2013 | 9:19 AM ET

Oct 25 (Reuters) - Abbott Laboratories said on Friday that the U.S. Food and Drug Administration approved its MitraClip medical device, used to stop heart valve leakage.

A slim majority of advisers to the FDA had recommended approval of the implantable heart device, as some had questioned whether it would be effective for its intended use.

The device was already approved for use in Europe and sells in 30 countries. It is used to treat mitral regurgitation, a condition in which the mitral valve of the heart does not close properly, causing blood leakage that can lead to stroke, heart attack or even death. It is designed for people who are considered to be at high risk for open-heart surgery.

It has estimated the disorder affects about one in 10 people aged 75 and older.

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