Abbott Receives CE Mark for Next-Generation TriClip G4 Transcatheter Tricuspid Valve Repair System

Compiled by Fan Dongdong

Abbott’s Latest-Generation Upgraded Minimally Invasive Transcatheter Tricuspid Valve Repair System, TriClip G4, Receives CE Mark Approval from European Regulatory Authorities to Help Prevent Blood Leakage in Patients’ Tricuspid Valves

In April 2020, Abbott’s first transcatheter tricuspid valve repair system, TriClip, received CE marking approval in Europe, authorizing its commercial launch in the European market and other countries and regions that recognize the European CE mark. The approved indication is severe tricuspid regurgitation (TR), making TriClip the world’s first commercially available transcatheter, minimally invasive interventional device for tricuspid valve repair. This newly CE-marked version of the TriClip system is named TriClip G4.

Compared to the mitral valve on the left side of the heart, the tricuspid valve separates the right atrium and ventricle and is also responsible for pumping blood to the lungs to absorb new oxygen. Unlike the mitral valve on the left side of the heart, which has only two leaflets, repairing the tricuspid valve presents significant anatomical challenges. Tricuspid regurgitation is a common condition with high incidence and mortality rates. This disease is typically found in elderly patients with other health issues. If open-heart surgery poses too great a risk for these elderly patients, transcatheter procedures such as TriClip may offer a superior treatment option.

The TriClip system was developed based on the company’s other best-selling cardiac repair device, the MitraClip. The MitraClip helps treat mitral regurgitation, a condition in which blood flows backward through the valve with each heartbeat. Regurgitation is one of the most common valvular diseases. Once implanted in the patient, the MitraClip device grasps the two leaflets of the heart valve, creating two smaller openings to prevent blood from flowing backward.

The TriClip system utilizes the same clipping technology as the MitraClip system, allowing clinicians to approximate portions of each leaflet of the patient’s heart valve and tailor the procedural approach to the unique anatomy of each patient’s valve. Furthermore, Abbott has specifically designed a differentiated delivery system for tricuspid valve implantation, enabling operators to grasp each leaflet independently prior to fixation. During the procedure, physicians implant the TriClip system into the patient’s heart via the femoral vein, employing an edge-to-edge technique to clip together portions of the tricuspid valve leaflets, thereby reducing regurgitant blood flow.

Abbott previously conducted the TRILUMINATE trial across 21 medical centers in Europe and the United States to evaluate the safety and efficacy of TriClip in reducing tricuspid regurgitation. The trial results demonstrated that the severity of tricuspid regurgitation was reduced by at least one grade in 86% of patients, meeting the prespecified efficacy endpoint. At the 6-month follow-up, 3 out of 84 patients (4%) experienced serious adverse events, meeting the prespecified safety endpoint. Device-related leaflet adhesion occurred in 5 out of 72 patients (7%). No periprocedural deaths, conversions to surgery, device embolizations, myocardial infarctions, or strokes occurred during the trial. The trial confirmed that the TriClip system can safely and effectively reduce the severity of tricuspid regurgitation, with significant clinical improvement observed in patients at six months post-procedure.

In addition, TriClip has recently been approved in Canada, but the device has not yet received regulatory approval in the United States.

Reference Source:

1.Abbott customizes TriClip heart valve system with upgraded EU approval

2.Abbott Gets CE Mark Approval For Next-Generation TriClip Device - Quick Facts