The FDA approved the MitraClip as a treatment for patients with mitral regurgitation who are considered too high risk for mitral valve surgery.
The MitraClip is a minimally invasive device that is catheter based, making it a potentially suitable treatment for patients with significant symptomatic mitral regurgitation who may be too sick or frail to undergo open heart surgery. The device is delivered transfemorally to the heart and then implanted.
The FDA’s Circulatory System Devices Panel voted 5-3 in favor of Abbott’s MitraClip clip delivery system on March 20. Their recommendation was based on results from three trials: EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), EVEREST II High Risk and REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip System), which evaluated MitraClip therapy in high surgical risk patients with significant mitral regurgitation.
The MitraClip device received CE Mark in 2008 and is commercially available in Europe and other international markets. Abbott Park, Ill.-based Abbott announced the U.S. launch of the MitraClip in conjunction with the FDA’s approval.