Abbott has announced US Food and Drug Administration (FDA) approval for its Tendyne transcatheter mitral valve replacement (TMVR) system to treat people with mitral valve disease. The therapy is available for patients whose mitral valves are not functioning properly due to severe mitral annular calcification (MAC).
For patients with severe MAC who are at high risk for open-heart surgery and whose mitral valve cannot be successfully repaired with transcatheter edge-to-edge-repair, Tendyne offers an alternative minimally invasive treatment option.
“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 Paul Sorajja (Abbott Northwestern Hospital, Minneapolis, USA). “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.”
The design of the Abbott Tendyne system and the valve’s availability in multiple sizes allows it to adapt to a range of patient anatomies, the company says in a press release. The self-expanding valve is delivered through a small incision in the chest and then advanced into the heart to replace the mitral valve. The valve is fully repositionable and retrievable during implantation, allowing for the best possible outcome for people requiring a valve replacement.
“Tendyne is a much-needed addition to our comprehensive US 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.”
