Abbott has received approval from the U.S. Food and Drug Administration for its Tendyne transcatheter mitral valve replacement (TMVR) system. The device is designed to treat patients with mitral valve disease caused by severe mitral annular calcification (MAC), a condition that limits the function of the heart’s mitral valve due to calcium buildup. Tendyne provides a minimally invasive option for patients who are not eligible for open-heart surgery or cannot be treated with the MitraClip device. Delivered through a small incision, the valve is repositionable and retrievable during implantation, making it adaptable to a variety of patient anatomies.
Mitral valve disease can lead to symptoms such as chest pain, dizziness, and shortness of breath due to mitral regurgitation or stenosis. For patients with severe MAC and high surgical risk, treatment options have been limited. Tendyne addresses this gap by offering an alternative that avoids open-heart surgery. Its availability in multiple sizes and self-expanding design supports better outcomes across a diverse patient population. Sandra Lesenfants, Senior Vice President of Abbott's Structural Heart Business, cited, "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. 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."
