TCT 2019: TRILUMINATE Six-Month Results Support Abbott’s TriClip
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.
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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.
Abbott Laboratories’ medical device businesses grew 10.6% year over year in the third quarter of 2019 while its diagnostics business grew 6.6%, helping the company grow 7.6% overall, the company reported on 16 October.
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.