Abbott Stays Ahead Of Edwards In Transcatheter Mitral Valve Race With Tendyne CE Mark
Tendyne is indicated for the treatment of significant mitral regurgitation in patients who are not candidates for surgery. It complements Abbott’s MitraClip mitral valve repair device and is an important part of the company’s strategy to be the leading structural heart device company.
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January’s new medical device approvals include the US FDA approval of a new indication for Abbott’s Infinity deep brain stimulation system and a CE mark for Abbott’s Tendyne transcatheter mitral valve replacement system. Medtronic also announced CE marks for a new line of implantable defibrillators and resynchronization devices as well as a CE mark for its Percept PC neurostimulator.
The 500-patient REPAIR MR trial will evaluate Abbott’s MitraClip mitral valve repair device in patients who would face moderate risk during open heart surgery. MitraClip is currently approved only for patients who are not surgical candidates.
Registry data from France shows transcatheter aortic valve replacement patients have better outcomes with Edwards’ Sapien balloon-expandable valves than with Medtronic’s CoreValve self-expanding valves.