January 30, 2020
Abbott’s Tendyne TMVI System Receives CE Mark Approval
January 30, 2020—Abbott announced that its Tendyne transcatheter mitral valve implantation (TMVI) system received European CE Mark approval for the treatment of significant mitral regurgitation (MR) in patients requiring a heart valve replacement who are not candidates for open heart surgery or transcatheter mitral valve repair.
The Tendyne TMVI system is available in multiple sizes to treat a broad range of valve anatomies. The valve is fully repositionable and retrievable during implantation.
A postapproval study of the therapy will be co-led by Nicolas Dumonteil, MD, interventional cardiologist, Clinique Pasteur in Toulouse, France. The Tendyne system is an investigational device in the United States.
According to the company, the Tendyne TMVI system offers an alternative minimally invasive treatment option when the leaky valve needs to be replaced in patients at high risk for surgery or in clinical situations when the mitral valve is too damaged for a successful repair with a MitraClip device (Abbott).
Global trial results to date have demonstrated excellent procedural safety and have shown 98.9% of Tendyne patients experienced MR elimination at discharge, which was sustained through 1-year in this very sick patient group, noted Abbott.
Hendrik Treede, MD, commented in the company's announcement, “European approval for Abbott’s Tendyne mitral valve replacement therapy provides the clinical community with a new choice in how we approach correcting a leaking mitral valve. For the first time outside of clinical trial settings, heart teams now have a minimally invasive valve replacement therapy that is backed by an excellent safety profile and designed to help physicians reposition the device as needed for improved patient outcomes.” Dr. Treede is a Professor of Cardiac Surgery at University Hospital Bonn, Germany.