Breakthrough Status

Abbott Valve Replacement System Gets Breakthrough Device Designation

June 23, 2021

Abbott’s Tendyne transcatheter mitral valve replacement system has received Breakthrough Device status from the FDA.

More than 93 percent of patients enrolled in a Tendyne clinical trial had trace or no mitral valve regurgitation after two years with the replacement valves.

The breakthrough designation for the Tendyne system, which is in ongoing clinical trials, is for patients who have severe mitral annular calcification and need valve replacement but can’t get open-heart surgery.

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