Abbott’s MitraClip Unexpectedly Wins Recommendation from FDA Advisory Committee (w/video)

After a poor review by FDA’s own staff earlier in the week of Abbott’s MitraClip Mitral Valve Repair System, it was looking like the device may not be able to make it in the U.S. Nevertheless, yesterday FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee recommended approval of the system in a 5 to 3 vote, which paves the way for the product to eventually come to the U.S. market.

Having received approval in Europe over four years ago, the MitraClip is intended to repair diseased mitral valves without open heart surgery, an important option for patients not eligible for such invasive procedures.

Here’s an animation providing a basic overview of how the MitraClip functions:

 

Flashbacks: Abbott’s EVEREST II Study Demonstrates MitraClip Benefits at Two Years Post-Surgery; MitraClip Repair Device Showing Positive Results in Study; Percutaneous MitraClip System Debuts In Europe

Product page: MitraClip Mitral Valve Repair System…

Press release: FDA Advisory Committee Votes Favorably on Abbott’s Minimally Invasive MitraClip® Device for Patients with Significant Mitral Regurgitation Who Are Too High Risk for Surgery