Abbott has announced that new late-breaking data from the bRIGHT study has supported the benefits of its TriClip transcatheter edge-to-edge repair (TEER) system for the treatment of people with leaky tricuspid valves.
The US-based medical device maker has designed the TriClip device specifically for tricuspid heart valve repair. It is said to be the first-of-its-kind minimally invasive device.
The 30-day results from the bRIGHT study supported the safety and effectiveness of the TriClip system in patients with tricuspid regurgitation (TR).
The prospective, multi-centre, single-arm post-market study, which is claimed to be the largest real-world dataset for transcatheter tricuspid valve repair, assessed 511 patients in 26 sites across Europe.
According to the medical device company, the findings from the trial showed that the device has lowered tricuspid regurgitation and improved the quality of life.
In the study, 77% of the patients who received the TriClip system experienced a reduction in TR grade to moderate or less in 30 days.
The system also contributed to significant improvement in health status as 79% of patients achieved New York Heart Association (NYHA) Functional Class I/II and 56% of patients reported a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
Additionally, the TriClip system demonstrated a strong safety profile as only 2.5% of individuals who received the device experienced a major adverse event.
Abbott structural heart business senior vice president Michael Dale said: “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.
“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.”
Abbott said that the late-breaking data is built on prior study results that showed that TriClip is safe and effective in the treatment of leaky tricuspid valves.