Research & Development
Abbott announces positive clinical study data for both TriClip system and MitraClip therapy
Abbott has announced positive data from two separate studies, which looked at its TriClip transcatheter edge-to-edge repair (TEER) system and its MitraClip therapy for treating leaky valves in people with mitral regurgitation (MR).
The TriClip system’s safety and effectiveness were researched in the TRILUMINATE clinical study, which established it as superior to medical therapy used to treat patients with tricuspid regurgitation (TR) who are at risk for open-heart surgery. It found that 87% of patients who received the TriClip system experienced a significant reduction in TR grade moderate or less at 30 days, compared to 4.8% in the control group.
Speaking on the results, Abbott’s structural heart business senior vice president Michael Dale said, “[This] TRILUMINATE Pivotal data show[s] TriClip is the first minimally invasive device therapy for the treatment of tricuspid regurgitation to provide durable improvements in TR severity and quality of life that go beyond taking medication to manage symptoms. When left unaddressed, TR can be debilitating and life-threatening. By repairing the damage caused by structural heart disease, TriClip G4 and our latest technological innovations are helping people reclaim their lives so they can get back to doing what they love.” Abbott has also announced positive five-year data for its MitraClip therapy, which shows its long-term benefits in treating leaky valves in people with MR. It’s COAPT trial found MitraClip to be safe and effective, and that it cut hospitalisations by almost 50% while improving survival for heart failure patients with severe secondary MR. It reduced the risk of death by 30% and achieved durable MR reduction in 95% of patients with moderate-to-severe or severe to mild or moderate.
COAPT trial co-principal investigator Gregg W Stone said, “Secondary mitral regurgitation is difficult to diagnose and manage, and is often associated with a poor prognosis. These five-year COAPT results further confirm that MitraClip is safe and effective at treating secondary MR in advanced heart failure patients, durably reducing hospitalisations and helping patients live longer.”