Multiple clip sizes enable tailoring the therapy to patients' mitral valve anatomy and expand the spectrum of TEER-suitable patients
"MitraClip therapy has fundamentally changed the way doctors treat mitral regurgitation, provides a valuable therapy option that does not require open-heart surgery, and goes beyond simply managing symptoms with medications," said Jason Rogers, M.D., professor of cardiovascular medicine and director of interventional cardiology and structural heart training programs at the University of California, Davis Medical Center. "These late-breaking data demonstrate and strengthen the evidence that Abbott's MitraClip system consistently reduces MR in a broad range of patients, while restoring proper function of the mitral valve and improving patients' quality of life."
The MitraClip system has been commercially available in the U.S. since 2013 and in Europe since 2008. With more than 150,000 patients treated worldwide, MitraClip is approved in more than 75 countries, spanning regions in Asia, Africa, Europe, the Americas and Australia.
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"These results add to what's been proven through nearly two decades of clinical experience in transcatheter mitral repair – MitraClip provides long-term, significant mitral regurgitation reduction that changes and saves lives," said Michael Dale, senior vice president of Abbott's structural heart business. "Abbott was the first to offer a transcatheter mitral valve repair device that provides a minimally invasive treatment option for patients with MR who would otherwise go untreated, and we remain committed to addressing the unmet needs of people with structural heart conditions."
First Results from the TriClip TRILUMINATE Pivotal Trial
TRILUMINATE Pivotal is the first randomized, controlled clinical trial evaluating the safety and effectiveness of TEER with TriClip in 700 patients with severe TR in the U.S., Canada and Europe. The data from the roll-in cohort through 30 days show:
High implant success rate (99%)
At least a one-grade TR reduction in 91% of patients, with moderate or less residual TR achieved in 74%
Patients achieving around a 17-point improvement in the KCCQ score, a 30% improvement from baseline score, which demonstrates a substantial improvement in their quality of life
Three-Year Outcomes from the Amulet IDE Study
The Amplatzer Amulet LAA Occluder with dual-seal technology (consisting of a lobe or piece to fill the cavity of the LAA and a disc to close off the opening into the LAA) is the first and only minimally invasive treatment option to offer immediate and complete dual-sealing closure of the LAA, reducing the risk of stroke and eliminating the need for blood-thinning medication. The prospective, international, multi-center Amulet IDE trial is the largest randomized LAA occlusion study to date consisting of more than 1,800 patients, and three-year outcomes demonstrate the safety and effectiveness of Amulet, with data showing: