Abbott’s Tendyne First Transcatheter Mitral Valve to Win EU Clearance

Abbott just announced that it is the first company to receive European regulatory approval to introduce transcatheter mitral valve replacement procedures on the continent. The Tendyne Transcatheter Mitral Valve Implantation (TMVI) system is intended for mitral regurgitation patients for whom open-heart surgery is too risky and in cases where transcatheter valve repair is not appropriate.

Mitral valves are considerably more difficult to implant using minimally invasive means and some researchers in this field have been using artificial valves indicated for aortic valve replacements combined with novel imaging and 3D printing to get it right. The newly issued CE Mark for Abbott to introduce its Tendyne in the EU will provide an effective option for many seriously ill patients to treat their diseased mitral valves.

According to Abbott, Tendyne produced a 98.9% resolution of mitral regurgitation in patients receiving the valve in clinical trials. This is partly thanks to the design and multiple available sizes of the self-expanding valve that allows for implantation into a variety of patient anatomies. Moreover, the valve worked fine for at least a year after implantation.

“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, M.D., professor of cardiac surgery, University Hospital Bonn, Germany, in an Abbott announcement. “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.”

The device can be repositioned and completely removed, if necessary, during the implantation procedure. This helps to ensure optimal outcomes while avoiding invasive surgery in case something goes wrong and the implantation has to be aborted.

“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.”



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