Abbott’s Next-Gen TriClip Earns EU Nod

Abbott obtained CE mark for its next-gen TriClip Transcatheter Tricuspid Valve Repair System, the first-of-its-kind minimally invasive tricuspid heart valve repair device available in Europe to treat tricuspid regurgitation (TR). The TriClip G4 clip-based therapy is a non-surgical heart valve repair option to treat of TR, or a leaky tricuspid valve, that allows physicians to tailor repair of the valve to each patient’s anatomy.
 
Often referred to as the “forgotten valve” because of historically limited treatment options, the tricuspid valve has three leaflets controlling blood flow between the right ventricle and right atrium. When those leaflets don’t close properly, blood can flow in the reverse direction—known as regurgitation—forcing the heart to work harder. The condition typically impacts older individuals with multiple co-morbidities, making open-heart surgery a high risk and resulting in many people going untreated. When left unaddressed, TR can lead to debilitating conditions such as atrial fibrillation (AF), heart failure and, ultimately, death.¹
 
“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 tricuspid regurgitation who are not responding to medical therapy and are often so ill they cannot undergo surgery,” said Philipp Lurz, M.D., Ph.D., professor and deputy head of cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany told the press. “This newest generation device further improves cardiologists’ ability to safely and effectively repair the tricuspid valve, which historically has been extremely challenging to treat.”
 
Leveraging Abbott’s technology and body of evidence from the firm’s MitraClip device, TriClip was designed to treat the tricuspid valve’s complex anatomy. With a precise and stable delivery system engineered for navigating the right side of the heart, TriClip offers physicians new options for treating debilitating TR.
 
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.
 
TriClip is delivered to the heart via a catheter inserted through the femoral vein in the leg and clips together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. With its differentiated delivery system designed for the tricuspid valve and a steerable guiding catheter system, physicians can independently grasp and effectively clip leaflets of the tricuspid valve to reduce the regurgitation. This latest innovation includes two new clip sizes, offering clinicians a total of four sizes.  
 
“Tricuspid regurgitation is considered the most undertreated valve issue and our newest generation device to address it is the result of our unwavering commitment to restore health and improve the quality of life for patients with structural heart disease,” said Mike Dale, senior vice president of Abbott’s structural heart business. “Our novel TriClip therapy offers the best possible outcomes for people suffering from a debilitating condition and gives doctors even more options for customizing repair of this complex anatomy.”   
 
TriClip G4 also recently received Health Canada approval.