New Data Show Superiority of Abbott’s TriClip Device Compared to Medical Therap… – Press Release

• Late-breaking data presented at American College of Cardiology Scientific Sessions (ACC.23) and simultaneously published in The New England Journal of Medicine demonstrate TriClip was superior to medical therapy with significant improvements in quality of life and tricuspid regurgitation (TR)
• Findings show TriClip, an investigational device in the U.S. to treat a leaky tricuspid valve, demonstrated safety and met the primary endpoint

ABBOTT PARK, Ill., March 4, 2023 /PRNewswire/ — Abbott ABT today announced late-breaking data for the TriClip transcatheter edge-to-edge repair (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 (TR) who are at intermediate or greater risk for open-heart surgery.

The results were presented at the American College of Cardiology’s 72^nd Annual Scientific Session together with World Congress of Cardiology (ACC.23/WCC) held in New Orleans (March 4-6, 2023). These data were simultaneously published in The New England Journal of Medicine. 

Key Findings From the TRILUMINATE Pivotal Study
The trial met its composite primary endpoint demonstrating superiority of the TriClip system compared to the control group (win ratio 1.48, p=0.02), 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 reduction in TR to moderate or less (grade < 2) was achieved in 87% of patients with the device at 30 days vs. 4.8% in the control group, with TR reduction sustained and durable at one year.
• Significant improvement in quality of life. 50% of patients who received the device achieved at least a 15-point improvement in the…

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