Abbott’s TriClip G4 for Tricuspid Regurgitation Receives CE Mark

April 8, 2021—Abbott announced it has received CE Mark approval for its next-generation TriClip transcatheter tricuspid valve repair system. TriClip G4 is available in Europe to treat tricuspid regurgitation (TR). The company noted that TriClip G4 also recently received Health Canada approval.

TriClip was designed to treat the tricuspid valve's complex anatomy with a precise and stable transfemoral delivery system engineered for navigating the right side of the heart. It enables physicians to tailor the repair of the tricuspid valve to each patient’s unique anatomy.

The device works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. The new-generation TriClip G4 includes two new clip sizes, offering clinicians a total of four sizes to tailor the device to different patient anatomies.

The company advised that in the United States, the TriClip and TriClip G4 transcatheter tricuspid valve repair systems are approved for investigational use only.

According to the company, recent data for TriClip from the TRILUMINATE CE Mark study showed sustained symptomatic improvement, reduction in the severity of TR, and improvement in functional status, demonstrating the benefits of the therapy and ultimately proving TriClip as a safe and durable treatment option for high-risk patients with symptomatic moderate or greater TR.

In June 2020, Abbott announced the presentation of 1-year follow-up data from the TRILUMINATE study at the virtual PCR e-Course held online.

“Since its initial CE Mark in April 2020, TriClip has emerged as a much-needed treatment option, offering physicians the opportunity to dramatically improve the quality of life for people in Europe with severe, symptomatic TR who are not responding to medical therapy and are often so ill they cannot undergo surgery,” stated Philipp Lurz, MD, in Abbott’s announcement. “This newest generation device further improves cardiologists’ ability to safely and effectively repair the tricuspid valve, which historically has been extremely challenging to treat.” Dr. Lurz is professor and deputy head of cardiology, Heart Center Leipzig at University of Leipzig in Leipzig, Germany.