The launch of the TRILUMINATE Pivotal IDE study follows a smaller, single-arm TRILUMINATE trial that was conducted in Europe and the U.S. to evaluate the safety and performance of the TriClip repair system. Results from that study, presented during a late-breaking session at EuroPCR 2019, found that after 30 days, 86.6 percent of patients who received the TriClip device saw a reduction in TR severity of at least one grade. In addition to a strong safety profile for the procedures in patients considered to be at high risk for surgery, a significant proportion of patients also saw an improvement in their heart failure symptoms as assessed using the New York Heart Association (NYHA) functional classification and Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
"While we've made substantial progress on a number of fronts for challenging structural heart conditions, tricuspid regurgitation impacts far too many patients worldwide, and physicians are limited by a lack of meaningful therapy alternatives to surgery," said Neil Moat, M.D., chief medical officer of Abbott's structural heart business. "Early results with our TriClip repair system have been encouraging and we're excited to continue driving innovation that we believe will benefit more patients in the future."
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Abbott's transcatheter tricuspid valve repair system is an investigational device only. The TriClip valve repair system is built on the foundation of Abbott's MitraClip system, which has been commercially available in the U.S. since 2013 and in Europe since 2008. With more than 15 years of clinical experience and over 80,000 patients treated worldwide, the MitraClip system is the first and only transcatheter mitral valve therapy with proven safety and survival, and durable clinical outcomes.
About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
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