FDA approves self-expanding Tendyne TMVR device from Abbott
Abbott has received U.S. Food and Drug Administration (FDA) approval for its Tendyne transcatheter mitral valve replacement (TMVR) device to treat patients with severe mitral annular calcification (MAC). The self-expanding valve, which gained CE mark approval back in 2020, is available in multiple sizes and can be fully retrieved and repositioned as necessary 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,” Paul Sorajja, MD, 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, said in a statement. “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. 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.”
“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,” added 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.”
Abbott’s MitraClip device previously received FDA approval for transcatheter mitral valve repair, which is now more commonly known as transcatheter edge-to-edge repair. This latest approval gives the company an approved treatment choice for patients who require either a valve repair or a valve replacement.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.