Abbott’s Tendyne TMVR System Approved by FDA

May 27, 2025—Abbott announced FDA approval of the company’s Tendyne transcatheter mitral valve replacement (TMVR) system for the treatment of mitral valve disease. The Tendyne device is available for patients whose mitral valves are not functioning properly because of severe mitral annular calcification (MAC), noted the company.

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 a valve that has mitral regurgitation or stenosis, stated Abbott.

According to Abbott, the design of the Tendyne TMVR system’s design and the availability of the self-expanding valve in multiple sizes allows it to adapt to a range of patient anatomies. Additionally, the valve is fully repositionable and retrievable during implantation.

“MAC 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,” commented Paul Sorajja, MD, in the company’s press release. “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.”

Dr. Sorajja continued, “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 comorbidities or other factors. Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives.”

Dr. Sorajja is 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 in Minneapolis, Minnesota.