Abbott announces data from TRILUMINATE pivotal study

Abbott announced late-breaking data for the TriClip transcatheter edge-to-edge repair, or TEER, system, a first-of-its-kind minimally invasive device designed specifically for tricuspid heart valve repair. The TRILUMINATE Pivotal study evaluates the superiority of TriClip compared to medical therapy in treating patients with severe, symptomatic tricuspid regurgitation who are at intermediate or greater risk for open-heart surgery. The trial met its composite primary endpoint demonstrating superiority of the TriClip system compared to the control group, primarily driven by improvement in quality of life. Mortality or tricuspid valve surgery and heart failure hospitalizations did not appear different between the groups at one year. Other positive findings include: Significant reduction in TR grade; Significant improvement in quality of life; A strong safety profile. There were no occurrences of device embolization or device thrombus.