Abbott’s TriClip TEER Device Evaluated in Real-World bRIGHT Study

May 17, 2023—Abbott announced 30-day outcomes from the bRIGHT study of the company’s TriClip transcatheter edge-to-edge repair (TEER) system for treating real-world patients with tricuspid regurgitation (TR).

According to the company, bRIGHT is a prospective, multicenter, single-arm, postmarket study that enrolled 511 patients at 26 sites across Europe. The findings support the safety and effectiveness of the TriClip system in patients with TR.

The late-breaking results were presented at the EuroPCR conference held May 16-19 in Paris, France.

As outlined in Abbott’s press release, key 30-day findings include:

• Significant TR reduction to moderate or less in 77% of patients treated with the TriClip system
• Significant clinical improvements, with 79% of patients achieving New York Heart Association functional class I/II (ie, slight or no limitation of physical activity) and an approximately 60% improvement from the baseline proportion of 20%
• Significant quality-of-life and health status improvements, with 56% of patients reporting a 15-point improvement in Kansas City Cardiomyopathy Questionnaire score
• A strong safety profile, with 2.5% of patients who received the device experiencing a major adverse event (a composite of cardiovascular death, heart attack, stroke, new onset of kidney failure, and surgery for device-related adverse events).

“Many patients currently undergoing tricuspid TEER are at an advanced stage of the TR disease and experience severe symptoms impacting their overall health and well-being,” commented Professor Philipp Lurz, MD, in Abbott’s press release.

Prof. Lutz, who is Deputy Head of Cardiology, Heart Center Leipzig at University of Leipzig in Germany, added, “Building strong clinical evidence around the value of a procedure like tricuspid valve repair is critical, and the real-world outcomes of the bRIGHT study reinforce the safety and effectiveness of TriClip in reducing TR and improving quality of life.”

TriClip is approved for use in > 50 countries, including Canada and countries in Europe. It is an investigational device in the United States, advised Abbott.