Abbott Launches Feasibility Trial Of Tricuspid Version Of MitraClip
The TRILUMINATE trial will evaluate safety and effectiveness of its Tricuspid Valve Repair System for treating symptomatic moderate-to-severe tricuspid regurgitation. The device is similar to Abbott's successful MitraClip catheter-based device for treating mitral regurgitation.
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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.
The new indication covers functional mitral regurgitation, also known as secondary mitral regurgitation, which represents two-to-three times as many patients as the primary mitral regurgitation population MitraClip is already labeled for. The approval is supported by results from the COAPT trial, the first randomized trial to show that a mitral-valve repair could improve outcomes in patients with secondary mitral regurgitation.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions each month. This month's edition, covering a long list of device trial updates that occurred between Sept. 24 and Oct. 31, is headlined by Medtronic's APOLLO US pivotal trial of the Intrepid transcatheter mitral valve.