FDA Approves New Indication for Transcatheter Mitral Repair System

The FDA has expanded approval of the MitraClip transcatheter mitral repair system to patients with heart failure and secondary mitral regurgitation despite receiving medical therapy. Previously, MitraClip was approved only for those with primary mitral regurgitation.

The expanded indication was based on findings from a randomized trial in which MitraClip therapy plus guideline-directed medical therapy was compared with medical therapy alone in over 600 patients with secondary mitral regurgitation who were not candidates for surgery (NEJM JW Cardiol Nov 2018 and N Engl J Med 379:2307). MitraClip therapy resulted in a 47% reduced risk for heart failure hospitalization and a 37% lower risk for death within 2 years compared with medical therapy …