For many heart patients living with severe mitral valve disease, open-heart surgery is a risk they simply can’t afford to take. But now, there’s hope.
Abbott Laboratories has announced U.S. FDA approval for its Tendyne™ transcatheter mitral valve replacement (TMVR) system — a first-of-its-kind, minimally invasive device designed specifically for patients who suffer from mitral valve disease due to severe mitral annular calcification (MAC) and are too high-risk for traditional open-heart surgery.
The Tendyne system, developed by the North Chicago-based healthcare giant, is designed to replace the failing mitral valve without opening the chest — a game-changer for patients who have long had limited treatment options.
“Patients with MAC can be very difficult to operate on,” said Dr. Paul Sorajja, director of the Center for Valve & Structural Heart Disease at Abbott Northwestern Hospital. “Many are considered too high risk due to multiple health complications. Tendyne bridges a critical treatment gap for these patients.”
A Minimally Invasive LifelineMAC is a condition where calcium builds up in the ring-like structure that supports the mitral valve. This stiffens the valve, causing regurgitation (leaky valve) or stenosis (narrowing), and leading to troubling symptoms like chest pain, breathlessness, and fatigue. In such cases, standard surgical valve replacement becomes dangerous or even impossible.
Enter Tendyne. The device is delivered through a small incision in the chest, guided into place inside the heart. Once implanted, it replaces the faulty valve — and unlike older devices, it can be repositioned or removed during the procedure to ensure optimal placement.
This flexibility, along with its range of sizes tailored to fit diverse patient anatomies, makes Tendyne a standout in structural heart care.
Expanding Access, Saving Lives
Abbott already offers the MitraClip™, a well-known non-surgical device used to repair mitral valves. However, it’s not suitable for all patients — particularly those with severe MAC, whose valves are too damaged to repair. Tendyne now fills that treatment gap.
“This approval builds on more than two decades of Abbott’s leadership in mitral valve therapies,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “Tendyne is a much-needed addition to our portfolio, offering a less invasive treatment option that can truly improve — and in some cases, save — lives.”
For patients and caregivers navigating the difficult journey of valve disease, the news is not just another medical milestone — it’s a second chance at life without surgery.
