Next generation TriClip gains CE mark approval


Abbott has received CE mark for its next-generation 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 clip-based therapy, known as TriClip G4, is a non-surgical heart valve repair option specifically designed for the treatment of TR, or a leaky tricuspid valve, that allows physicians to tailor repair of the valve to each patient’s unique anatomy.

“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, professor and deputy head of cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany. “This newest generation device further improves cardiologists’ ability to safely and effectively repair the tricuspid valve, which historically has been extremely challenging to treat.”

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 works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.

“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.”


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