(Reuters) CHICAGO – A slim majority of advisers to the U.S. Food and Drug Administration voted on Wednesday for approval of Abbott Laboratories’ implantable heart device MitraClip, saying it had more benefits than risks.
The eight members of the advisory panel voted unanimously to recommend the device’s safety. However, in a tie-breaker vote it voted 5-4 against the question of whether there was a reasonable assurance MitraClip would be effective for its intended use.
Overall, the members voted 5-3 to agree that the device’s benefits outweighed its risks.
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The recommendation comes as a surprise after FDA staff reviewers made negative comments about MitraClip on Monday, seeking more data to show the device’s safety and effectiveness.
The FDA usually takes its advisers’ votes into consideration when it decides on whether to approve a device for sale. In a statement, Abbott said it expects the FDA’s final decision later this year.
“We look forward to continuing discussions with the agency regarding the panel’s comments,” Charles Simonton, chief medical officer at Abbott Vascular, said in a statement.
MitraClip, which is currently selling in 30 countries, treats 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.
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MitraClip works by clipping the leaflets of the leaky mitral valve and is designed for use only in those patients with the condition who are considered high-risk for open-heart surgery.
Abbott estimates the disorder affects about one in 10 people aged 75 and older.
The Abbott Park, Illinois company’s shares closed at $33.81 on Wednesday on the New York Stock Exchange.
(Reporting by Zeba Siddiqui in Bangalore; Editing by Paul Tait)
