Abbott nets first CE mark for transcatheter mitral valve replacement

Abbott received a CE mark for a first-of-its-kind transcatheter mitral valve implantation system, aimed at stopping leakage and backflow within the heart when open surgery or minimally invasive repair procedures are not an option.

The bioprosthetic Tendyne system includes a self-expanding device, similar to transcatheter replacements for the nearby aortic valve. It completely supplants the person’s bicuspid mitral valve, and is designed as an alternative for when the valve is too damaged to be repaired with the company’s top-selling MitraClip device.

The new valve is delivered via a small incision in the chest wall, and placed with a catheter that is threaded up through the bottom of the beating heart muscle. Abbott says it is available in multiple sizes and can adapt to different patient anatomies, and is also repositionable and retrievable during implantation.

“The availability of Tendyne as a treatment option in Europe provides physicians with an additional tool that has been shown to completely correct [mitral regurgitation] in very ill patients, and it adds to Abbott's portfolio of life-changing and life-saving treatments,” Michael Dale, senior VP of Abbott's structural heart business, said in a statement.

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In a global clinical trial, 98.9% of patients receiving the Tendyne valve showed no signs of regurgitation at discharge, according to the company, as well as at the one-year mark following the procedure. Currently, the device is under investigational use in the U.S.

Abbott acquired the device in a $250 million deal in mid-2015, through its acquisition of the eponymously named startup Tendyne, based in Roseville, Minnesota. At the same time, it made a separate investment in Cephea Valve Technologies—makers of a mitral valve delivered via catheter through a vein in the leg—and Abbott exercised its option to acquire that company in January of last year.