Abbott’s TriClip system demonstrated a strong safety profile in the TRILUMINATE Pivotal trial. Credit: City of Temecula / Flickr (Creative Commons).

Abbott has reported positive late-breaking data from the TRILUMINATE Pivotal trial of its TriClip transcatheter edge-to-edge repair (TEER) system.

The randomised, controlled clinical trial was designed to assess the effectiveness and safety of transcatheter repair with the TriClip system against medical therapy as a treatment for severe, symptomatic tricuspid regurgitation (TR) patients who are at greater risk for open-heart surgery.

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The findings showed that the TriClip system established superiority compared to the control group, and the trial met its composite primary endpoint.

This was mainly driven by improvement in quality of life.

In the trial, 87% of patients treated with the TriClip system had a significant reduction in TR, to moderate or less, at 30 days compared to 4.8% of patients in the control group.

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Additionally, 50% of the patients who received the device achieved significant improvement in quality of life.

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The TriClip device also demonstrated a strong safety profile, with no device embolisation or thrombus reported in the trial.

Abbott structural heart business senior vice-president Michael Dale said: “These TRILUMINATE Pivotal data show 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.”

In a separate development, the company reported that its MitraClip therapy showed long-term benefits in the treatment of leaky valves in heart failure patients with secondary mitral regurgitation (MR).

Data from the five-year COAPT trial demonstrated that the MitraClip is effective, safe and can reduce hospitalisation rates while improving survival for indicated patients.