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The FDA has approved the MitraClip device for patients with severe mitral regurgitation, its manufacturer announced today.

The device -- which is delivered percutaneously -- was cleared for use in patients with significant symptomatic degenerative mitral regurgitation who have a prohibitively high risk of complications from open-heart mitral valve surgery, which is the standard of care, according to the statement from Abbott Vascular.

Earlier this year, an FDA advisory committee backed the device, but not without some concerns. Although the safety of the device was unanimously affirmed, only four out of the nine members supported the efficacy of the device. On the final question of recommending approval, however, five out of eight voting members decided that the benefits of the device outweighed the risks.

In briefing documents released before the meeting, FDA reviewers had recommended against approval, citing questions about the study design of the pivotal EVEREST II trial. They suggested that waiting for the results of two ongoing trials looking at the MitraClip device for slowing the progression of heart failure -- and -- might be helpful.

In EVEREST II, 30-day results reported in 2010 showed that MitraClip reduced the rate of major adverse clinical events compared with surgery (9.6% versus 57%), a difference mostly driven by use of transfusions.

That benefit didn't hold up in the 2-year results reported a year later, however. Surgery was superior on the composite endpoint of freedom from death, mitral valve surgery, or reoperation for severe mitral regurgitation.

Real-world experience supports the effectiveness of the device, however. A registry study reported at the European Society of Cardiology meeting in 2012 showed that MitraClip was associated with significant improvements in symptoms and functional outcomes at 1 year in patients with severe mitral regurgitation.

Abbott said the device would launch immediately in the U.S.

From the American Heart Association:

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