Abbott’s Tendyne system is the first FDA-approved transcatheter device to replace the mitral valve without open-heart surgery in patients with severe mitral annular calcification.

The FDA has approved Abbott’s Tendyne transcatheter mitral valve replacement system for the treatment of patients with mitral valve disease due to severe mitral annular calcification (MAC). This approval offers a therapeutic option for patients who are not candidates for surgical mitral valve repair or replacement and cannot be treated effectively with the MitraClip device.

Severe MAC presents technical challenges in surgical mitral interventions due to extensive calcification of the annulus, which may lead to mitral regurgitation or stenosis. These structural changes can impair cardiac function and contribute to symptoms such as dyspnea and angina. Many patients with MAC are considered high-risk surgical candidates due to multiple comorbidities or other factors.

Tendyne is a self-expanding, repositionable, and retrievable valve that is delivered through a small incision in the chest. Its design accommodates varying mitral anatomies and allows intraprocedural adjustments to optimize valve positioning and function. The device expands Abbott’s portfolio of transcatheter structural heart therapies by addressing the limited options that were available to this subset of patients.

According to Paul Sorajja, MD, of the Minneapolis Heart Institute, “Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives."

Sandra Lesenfants, senior vice president of Abbott’s structural heart division said, “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.”

Important safety information for the Tendyne and MitraClip devices can be found at https://abbo.tt/TendyneISI and https://abbo.tt/MitraClipISI, respectively.

Source: Abbott