Abbott Releases Favorable, Late-Breaking Data for TriClip

Abbott released late-breaking data about its TriClip transcatheter edge-to-edge repair (TEER) system, a first-of-its-kind, minimally invasive device for tricuspid heart valve repair. The results were presented at EuroPCR.
 
Results of the bRIGHT study, the largest real-world dataset for transcatheter tricuspid valve repair, supported TriClip’s safety and effectiveness in tricuspid regurgitation (TR) patients. 511 patients in 26 sites across Europe were enrolled in this study.
 
Findings through 30 days included reduction of TR grade to “moderate or less” for 77% of patients. 79% of participants achieved New York Heart Association (NYHA) Functional Class I/II (meaning they reached a point of slight or no limitation of physical activity), an almost 60% improvement from the baseline proportion of 20%. Further, more than half (56%) of patients reported a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of symptoms, physical and social limitations, and quality of life), representing a substantial improvement in quality of life and health status.
 
2.5% of patients receiving TriClip experienced a major adverse event, a composite of cardiovascular death, heart attack, stroke, new onset of kidney failure, or surgery.
 
“Many patients currently undergoing tricuspid TEER are at an advanced stage of the TR disease and experience severe symptoms, impacting their overall health and well-being,” said Philipp Lurz, M.D., Ph.D., professor and deputy head of cardiology, Heart Center Leipzig at University of Leipzig, told the press. “Building strong clinical evidence around the value of a procedure like tricuspid valve repair is critical, and the real-world outcomes of the bRIGHT study reinforce the safety and effectiveness of TriClip in reducing TR and improving quality of life.”
 
“Just as we lead the way for treating mitral regurgitation with our MitraClip device, we’re excited about the opportunity to continue our track record of innovation to treat tricuspid regurgitation with our TriClip therapy,” added Michael Dale, senior vice president of Abbott’s structural heart business. “TriClip has already helped thousands of people in Europe since its introduction in 2020. As we work to make TriClip accessible to more people around the world, the latest data presented at EuroPCR are further proof that the therapy helps patients who have limited treatment options get back to living fuller, healthier lives.”
 
TriClip is approved in over 50 countries (including Europe and Canada) and is an investigational device in the U.S.