Abbott’s TriClip TEER System Approved by FDA to Treat Tricuspid Regurgitation

April 2, 2024—Abbott announced that the FDA has approved the company’s TriClip transcatheter edge-to-edge repair (TEER) system, which is designed for the treatment of tricuspid regurgitation (TR).

The approval comes after the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee confirmed (13 to 1) that the benefits of TriClip outweighed the risks, which Abbott announced on February 13, 2024.

According to Abbott, TriClip’s TEER technology, which is delivered through a vein in the leg, works by clipping together a portion of the leaflets to repair the tricuspid valve and help blood flow in the right direction without the need for open heart surgery. The company noted that, on average, patients who receive TriClip need only 1 day in the hospital before they recover and can return home.

Paul Sorajja, MD, who is Coprincipal Investigator of the TRILUMINATE pivotal trial of the device, commented on this development in the company’s press release.

“The United States approval of TriClip is a significant advancement for people suffering from TR, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues,” stated Dr. Sorajja. “With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open heart surgery that may not be feasible for individuals with TR who are generally older and sicker.”

Dr. Sorajja is the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, Minnesota.

Abbott reported that the FDA reviewed findings from the TRILUMINATE pivotal trial, a randomized, controlled clinical study that evaluated the safety and effectiveness of the TriClip system compared to medical therapy in patients with severe TR who are at intermediate or greater risk for open heart surgery.

As summarized in the press release, 90% of patients who received the TriClip system in the study experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days—a reduction that was sustained at 1 year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life.

In April 2020, Abbott announced CE Mark approval of TriClip. It has been approved for use in more than 50 countries, including in Europe and Canada.

TriClip, which was specifically designed to treat the tricuspid valve’s complex anatomy, leverages the same clip-based technology as Abbott’s MitraClip device, which was designed to treat mitral regurgitation, stated the company.