The FDA approved Abbott's Tendyne minimally invasive heart replacement for mitral valve disease that could disqualify ...

Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne™ transcatheter mitral valve replacement (TMVR) system to treat people with mitral ...

The approval is tightly defined: the system will be for patients ineligible for surgery and with anatomy unfavorable for TEER ...

Abbott (NYSE: ABT) announced today that it received FDA approval for its Tendyne transcatheter mitral valve replacement (TMVR ...

The system is available for patients whose mitral valves are not working properly due to severe mitral annular calcification.

The Tendyne system is designed for those who are considered high-risk for traditional open-heart surgery and for whom mitral valve repair with Abbott’s MitraClip is not a viable option.

The FDA gave the OK for the North Chicago-based medical device maker's Tendyne transcatheter mitral valve replacement.

Abbott has announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne transcatheter mitral valve replacement (TMVR) system to treat people with ...

The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, known as severe mitral annular calcification (MAC) Tendyne ...