First-of-Its-Kind Device Replaces Mitral Valve Without Open-Heart Surgery

Mitral annular calcification (MAC) stiffens the structure of the mitral valve due to a buildup of calcium in the base of the valves 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. The complex nature of mitral valve disease and patients' specific needs and health conditions can pose challenges for surgical correction. 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. Now, a novel transcatheter mitral valve replacement (TMVR) system offers a new treatment option for patients who are not candidates for open-heart surgery or mitral repair.

Abbott’s (Abbott Park, IL, USA) Tendyne TMVR system offers an alternative minimally invasive way to replace the valve that's leaky (mitral regurgitation) or narrowed (stenosis) 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. The innovative and unique 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 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. The U.S. Food and Drug Administration (FDA) has approved Abbott’s Tendyne TMVR system to treat people with mitral valve disease, making this life-changing therapy available for patients whose mitral valves are not functioning properly due to severe MAC.

"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."