Abbott gathering real-world data on FDA-approved TriClip system

July 28, 2026 - 23:18

Abbott is moving forward with a new study to track how its TriClip system performs outside of clinical trials. The device, which treats tricuspid regurgitation, has already received approval from the U.S. Food and Drug Administration and is covered by Medicare. Now, the company wants to see how it works in everyday medical practice.

Researchers plan to enroll 1,000 patients and follow them for five years. The goal is to gather real-world data on the device's safety and effectiveness. Tricuspid regurgitation is a condition where the heart's tricuspid valve does not close properly, causing blood to flow backward. This can lead to fatigue, swelling, and other serious complications. Until recently, treatment options were limited, especially for patients too frail for open-heart surgery.

The TriClip system offers a less invasive option. It is delivered through a catheter and clips the valve leaflets together to reduce leakage. While the FDA approval was based on controlled studies, Abbott wants to see if those results hold up in a broader, more diverse patient population. The new data will help doctors understand who benefits most from the procedure and how long the improvements last. The study is expected to provide valuable insights for both clinicians and regulators as the device becomes more widely used.