The FDA's Circulatory System Devices advisory panel has voted in favor of Abbott Laboratories' MitraClip device, which is used to treat a heart valve problem, mitral regurgitation. The device is only recommended for patients who are at an increased risk for an open heart surgery.
There were mixed responses from the panelists regarding the efficacy of the device in improving the condition of the patients due to the lack of sufficient randomized clinical trial data. The members struggled to identify the patient groups who really benefitted from the device.
AdvertisementHowever, after a long discussion, the panel voted 5-3 in favor of the device. They were unanimous regarding the device safety.
MitraClip is currently being sold in 30 countries. Abbott awaits the FDA's final decision.
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