Abbott has received U.S. Food and Drug Administration (FDA) approval for its Tendyne transcatheter mitral valve replacement (TMVR) system to treat mitral valve disease.

The therapy can help patients whose mitral valves aren’t functioning correctly because of severe mitral annular calcification (MAC). MAC is a buildup of calcium in the annulus that supports the mitral valve.

This stiffens the mitral valve’s structure and can lead to regurgitation or stenosis that disrupt the heart’s ability to pump blood effectively. The conditions can cause chest pains, shortness of breath, and dizziness, according to Paul Sorajja, M.D., 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,” Dr. Sorajja told the press. “Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives.”

Tendyne is another minimally invasive alternative for patients with severe MAC at high risk for open-heart surgery, whose leaky or narrowed mitral valve can’t be repaired with Abbott’s MitraClip device.

The system comes in multiple sizes, letting it adapt to a range of anatomies. The self-expanding valve is delivered through a small chest incision, then advanced into the heart to replace the mitral valve. The valve is repositionable and retrievable during implantation.

“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, senior vice president 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.”