News Briefs: Approvals For Abbott’s MitraClip, Allergan’s Juvéderm; Diagnostics News

Abbott Vascular announced Oct. 25 receipt of a PMA for its catheter-based MitraClip to treat patients with significant symptomatic degenerative mitral regurgitation who are at a prohibitive risk for mitral valve surgery. A mechanical clip, delivered by a catheter and a steerable sleeve through the femoral vein, MitraClip grasps and coapts the mitral valve leaflets, resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle without the need for an invasive surgical procedure. The company plans an immediate launch of what is the first percutaneous mitral valve repair system available in the U.S. The device received a CE mark in 2008 and is commercially available in Europe and other countries overseas, according to the company. The approved indication is for percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation, which differs slightly from the proposed indication.

FDA’s Circulatory System Devices Advisory Committee voted 5-3 in favor of MitraClip in March, contrary to the advice of FDA’s reviewers, who questioned the safety and effectiveness of the device