FDA Approves Abbott’s Minimally Invasive TMVR System for Mitral Valve Disease

The U.S. FDA has approved Abbott’s Tendyne transcatheter mitral valve replacement (TMVR) system, marking the first device designed to replace the mitral valve without open-heart surgery. It is intended for patients with severe mitral annular calcification (MAC)—a condition involving calcium buildup around the mitral valve—who are not candidates for surgical or edge-to-edge repair.

Tendyne offers a less invasive alternative for patients with leaky or narrowed mitral valves and is especially suited for those at high surgical risk or ineligible for Abbott’s MitraClip system. The device features a self-expanding, repositionable valve available in multiple sizes to fit varying anatomies and is delivered via a small chest incision.

Abbott highlighted that treating mitral valve disease is complex due to diverse patient profiles. This approval complements the company’s broader cardiac portfolio, including recent advances like the FreeStyle Libre CGM, shown to reduce heart-related hospitalisations in diabetics.

03-06-2025