Dive Brief:

• Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system has reduced the severity of tricuspid regurgitation in a pivotal clinical trial.
• The study, results from which were published in The New England Journal of Medicine, showed that TEER beat the established medical therapy on the primary composite endpoint, primarily because of its effect on a measure of quality of life.
• Abbott, which already sells the device in the European Union, delivered the data as it prepares for a U.S. launch that could see it compete with Edwards Lifesciences for a new market.

Dive Insight:

If Abbott can bring TriClip to the U.S., it will unlock a new growth opportunity. Edwards Lifesciences, the developer of the rival Pascal device, has projected the transcatheter mitral and tricuspid therapy market to grow to $5 billion by 2028.

Patients with tricuspid regurgitation who are too high risk for surgical repair live with severe symptoms related to the accumulation of fluid in the organs and legs. Medicines can help manage some symptoms but the need remains for more effective, lasting improvements. Abbott’s TriClip could address the unmet need by holding the tricuspid-valve leaflets in place.

To test that idea, investigators randomized 350 people with severe tricuspid regurgitation to receive TriClip or medical therapy. The primary endpoint was a composite measure that looked at death, heart failure and quality of life. 

After one year, the primary endpoint results favored the TEER group, despite the incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure being similar in both cohorts. The primary endpoint improvement was driven by a 12.3-point change on the TriClip quality of life score that was significantly bigger than the 0.6-point change seen in the control cohort. 

Abbott also tracked a significant improvement in tricuspid regurgitation severity. After 30 days, 87.0% of patients in the TriClip cohort had moderate tricuspid regurgitation, at worst, compared to 4.8% of people in the control group. Almost all, 98.3%, of recipients of TriClip were free from major adverse events at 30 days.

“There have historically been very few treatment options for tricuspid regurgitation,” cardiologist Paul Sorajja of the Minneapolis Heart Institute Foundation said in a statement. Viewed alongside real-world evidence from Europe, the data shows that TriClip can “safely and effectively repair the tricuspid valve in patients and improve their quality of life,” he said.