Abbott (Abbott Park, Illinois) has received FDA PMA approval for its catheter-based MitraClip therapy for mitral regurgitation (MR) and the company says it plans to launch the device immediately in the U.S. 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 judgment of a heart team due to the presence of one or more documented surgical risk factors.
Read More
