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FDA Advisory Committee Gives Thumbs-Up to Abbott's MitraClip

An FDA advisory committee has voted that the benefits outweigh the risks for Abbott’s (NYSE: ABT  ) MitraClip device in treating mitral regurgitation patients at too high a risk for open mitral valve surgery. The mitral valve is in the heart.

The committee voted with five positive opinions and three negative ones, according to an Abbott press release, and the committee voted in favor of the device’s safety profile without a single negative opinion, although the panel was mixed when voting over MitraClip’s reasonable assurance of efficacy, with four saying "yes" and five saying "no."

The MitraClip device is designed to treat mitral regurgitation, the most common form of heart valve insufficiency, according to Abbott. The ailment causes blood to flow back through the mitral valve and into the heart’s left atrium, a condition that can ultimately lead to severe or even fatal problems such as heart attack or stroke.

Abbott’s MitraClip gained CE Mark approval in Europe in 2008 and is commercially available in numerous international markets already. The company’s still trying to gain approval from the FDA in the U.S., but the advisory committte’s recommendation should help the decision, which the company expects later this year.


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