May 27, 2025- Abbott announced the U.S. Food and Drug Administration (FDA) has approved the company’s Tendyne™ transcatheter mitral valve replacement (TMVR) system to treat people with mitral valve disease. This life-changing therapy is available for patients whose mitral valves are not functioning properly due to severe mitral annular calcification (MAC), a buildup of calcium within the ring-like structure (known as an annulus) that supports the mitral valve.
The complex nature of mitral valve disease and patients’ specific needs and health conditions can pose challenges for surgical correction. For patients with severe MAC who are at high risk for open-heart surgery and whose mitral valve cannot be successfully repaired with the Abbott MitraClip™ device, Tendyne offers an alternative minimally invasive way to replace the valve that’s leaky (mitral regurgitation) or narrowed (stenosis).