The company presented study data at EuroPCR in Paris. This study evaluated TriClip, a first-of-its-kind, minimally invasive device, in treating patients with leaky tricuspid valves.
Abbott’s bRIGHT study supported the safety and effectiveness of TriClip in 511 patients with tricuspid regurgitation (TR). The largest real-world dataset for transcatheter tricuspid valve repair produced thirty-day outcomes from patients across 26 sites in Europe.
Abbott reports key findings from the bRIGHT study
Key findings included significant TR reduction, with TR grade reducing to moderate or less in 77% of patients. Additionally, 79% of participants achieved New York Heart Association (NYHA) Functional Class I/II. This means they reached a point of slight or no limitation of physical activity, marking a nearly 60% improvement from the baseline proportion of 20%.
Abbott reported that 56% of patients reported a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. That score represents a substantial improvement in quality of life and health status.
Only 2.5% of patients who received TriClip devices experienced a major adverse event, Abbott said. That’s marked by a composite of cardiovascular death, heart attack, stroke, new onset of kidney failure and surgery for device-related adverse events.
“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,” said Michael Dale, SVP 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 holds approval for use in more than 50 countries, including in Europe and Canada. It remains investigational in the U.S.