FDA grants approval for Tendyne, first-of-its-kind device to replace the mitral valve without open-heart surgery – Abbott

Abbott announced the 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).

“Tendyne is a much-needed addition to our comprehensive U.S. structural heart portfolio that offers less invasive treatment options for a range of heart diseases,” said Sandra Lesenfants, SVP of Abbott’s structural heart business. “This approval builds on our more than two decades of mitral valve leadership that includes developing first-of-their-kind devices that truly change – and save – people’s lives.”

“Mitral annular calcification stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupt the heart’s ability to pump blood effectively. These conditions can have a significant impact on a patient’s quality of life, causing symptoms such as chest pains, shortness of breath and dizziness,” said Dr. Paul Sorajja, the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital. “Unfortunately, patients with MAC can be very difficult to operate on and many are considered too high risk for open-heart surgery due to multiple co-morbidities or other factors. Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives.”