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.
However, 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.