Abbott’s Tendyne Transcatheter Mitral Valve Implantation (TMVI) technology has obtained CE Mark for transcatheter mitral valve implantation.
Tendyne TMVI, now approved for use in Europe, expands the company’s portfolio of new minimally invasive mitral valve solutions, together with MitraClip proved to increase life expectancy and quality of life as part of the COAPT trial.
The therapy treats significant mitral regurgitation (MR) in patients requiring a heart valve replacement and provides relief from heart failure symptoms and quality-of-life improvement.
It also provides a safe solution for MR patients who are not candidates for open-heart surgery or transcatheter mitral valve repair.
Abbott structural heart business senior vice-president Michael Dale said: “The launch of the Tendyne device builds upon our history of developing groundbreaking therapies that offer new treatment options for people with serious structural heart conditions who have limited treatment options.
“The availability of Tendyne as a treatment option in Europe provides physicians with an additional tool that has been shown to completely correct MR in very ill patients and it adds to Abbott’s portfolio of life-changing and life-saving treatments.”
MR is the most common heart disease that affects the heart valves and is a life-threatening condition whereby the heart’s mitral valve fails to close entirely. As a result, blood flows backwards into the left atrium of the heart.
Tendyne system offers an alternative minimally invasive treatment option for patients at high-risk for open-heart surgery or in clinical situations when the mitral valve is too damaged.
Due to its unique design, the self-expanding valve Tendyne TMVI can adapt to a range of patient anatomies, delivered through a small incision in the chest and up through the heart, implanted in a beating heart.
Available in multiple sizes to treat a range of valve anatomies, Tendyne is completely repositionable and retrievable at the time of implantation.