FDA Grants Breakthrough Device Status to Abbott's Tendyne™ Mitral Valve Replacement System

Abbott has announced that the U.S. Food and Drug Administration has approved its Tendyne™ transcatheter mitral valve replacement system.
 
The device is intended for patients with mitral valve disease caused by severe mitral annular calcification (MAC), a condition in which calcium builds up in the ring-like structure that supports the mitral valve.

Mitral valve disease can make it difficult for the heart to pump blood properly and often affects people who are not suitable candidates for traditional surgery. 

The Tendyne system offers a less invasive option for patients with severe MAC who are at high risk for open-heart surgery and cannot be effectively treated with Abbott’s MitraClip™ device.

Severe MAC can lead to mitral regurgitation or stenosis, which are conditions where the valve becomes leaky or narrowed. These problems can reduce a person’s quality of life and lead to symptoms such as chest pain, breathlessness, and dizziness. 

Surgery is often not an option for people with MAC due to other health issues, which can make the condition difficult to manage.

The Tendyne system is designed to address this treatment gap. It is a self-expanding valve that can be delivered through a small incision in the chest and guided into place within the heart. 

The device is available in a range of sizes to fit different patients and can be repositioned or retrieved during the procedure to ensure the best possible result.

The addition of Tendyne strengthens Abbott’s structural heart portfolio and provides another option for doctors treating complex heart conditions in patients who cannot undergo traditional surgery.