Abbott Launches US Pivotal Trial Of TriClip Transcatheter Tricuspid Valve Repair System
The 700-patient TRILUMINATE Pivotal will compare Abbott’s TriClip transcatheter tricuspid valve repair device to medical therapy alone. TriClip is a tricuspid version of the company’s successful MitraClip transcatheter mitral valve repair device.
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The six-month results of the TRILUMINATE Feasibility trial support the safety and effectiveness of Abbott’s TriClip, a version of the company’s successful MitraClip adapted to repair the tricuspid valve. The company is now sponsoring a pivotal trial to support FDA approval of TriClip.
Early results of the TRILUMINATE trial presented at the EuroPCR conference will support a CE mark for a version of MitraClip adapted to reduce tricuspid valve regurgitation.
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