MitraClip (Abbott) is FDA approved for Mitral Regurgitation

Abbott announced that its first-in-class, catheter-based MitraClip therapy has received FDA approval and will launch immediately in the United States , providing physicians with a breakthrough treatment option for patients suffering from Mitral Regurgitation (MR). The MitraClip device has been approved for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve of the heart. Prohibitive risk is determined by the clinical judgement of a heart team due to the presence of one or more documented surgical risk factors.

The MitraClip System received CE Mark approval in 2008.