Abbott said that the U.S. Food and Drug Administration (FDA) approved its Tendyne™ Transcatheter Mitral Valve Implantation (TMVI) system. The groundbreaking device is the first of its type to win approval in the U.S. to treat mitral valve disease without open-heart surgery.
The Tendyne system is generally reserved for patients with severe MAC who are at very high risk for conventional open-heart surgery and whose condition cannot be adequately treated with Abbott’s MitraClip™ device. The device is a solution for either a leaky mitral valve (mitral regurgitation) or a narrowed valve (stenosis).
The self-expanding Tendyne valve is implanted in the heart via a modest chest incision, providing an alternative to less invasive valve replacement. An important aspect of the Tendyne system is that it is fully repositionable and retrievable during implantation, providing surgeons with greater control and accuracy.
Mitral annular calcification stiffens the structure of the mitral valve 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,
Unfortunately, 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. Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives.
Paul Sorajja
A Minimally Invasive Solution for Mitral Valve Disease
The Tendyne system is intended to treat mitral valve disease, specifically those with valves that are impaired by calcium deposits at the base. This may result in mitral regurgitation, in which blood flows backward into the heart, presenting symptoms such as weakness and shortness of breath. Conventional treatment usually entails open-heart surgery, but this is not acceptable for every patient because there are those who are too old or have comorbidities.
A Milestone in Cardiac Care
The FDA approval of Tendyne represents a major breakthrough in the management of structural heart disease. It offers a new alternative for patients who previously had few options because of the invasiveness of conventional surgical techniques. With the approval, Abbott continues to prove itself dedicated to delivering cutting-edge solutions that enhance patient outcomes and quality of life.
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