The Tendyne Transcatheter Mitral Valve Implantation system received the CE Mark, meaning it is approved for commercial use in Europe, Abbott announced Thursday.
“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,” said Hendrik Treede, MD, professor of cardiac surgery, University Hospital Bonn, Germany, in Abbott’s news release announcing the approval. “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.”
According to the company, the Tendyne valve is a first-of-its-kind therapy to replace the mitral valve in patients in need of symptom relief and quality-of-life improvement without open surgery and when transcatheter mitral repair is not possible. Global trial results to date have demonstrated excellent procedural safety and have shown that 98.9% of patients who received the Tendyne valve experienced no or trace mitral regurgitation (MR), which was sustained through 1 year in this very sick patient group, Abbott 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,: said Michael Dale, senior vice president of Abbott’s structural heart business. “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.”
The Tendyne valve remains an investigational device in the U.S.