The FDA’s Circulatory System Devices Panel voted today to make its recommendation regarding Abbott’s (NYSE:ABT) premarket approval application for the MitraClip heart implant, agreeing unanimously that the device is safe but issuing a mixed result on the effectiveness and potential risks of the device.
The panelists voted 8-0 that the MitraClip implant proved safe in clinical trials and 5-3 that the device’s benefits outweigh its risks. The panel was evenly split 4-4 on the question of effectiveness, prompting a tie-breaking opinion from the panel chair, who voted that the available data did not demonstrate effectiveness for MitraClip.
The MitraClip implant has been at the center of some dramatic turns this week after the FDA’s internal reviewers in documents released ahead of the panel meeting recommended against approval for the U.S. market.
