Abbott have received CE Mark approval for its next-generation TriClip Transcatheter Tricuspid Valve Repair System, the first-of-its-kind 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.
The tricuspid valve has three leaflets that control the flow of blood between the two chambers on the right side of the heart. When those leaflets do not close properly, blood can flow in the reverse direction – known as regurgitation – forcing the heart to work harder.
The condition typically impacts older patients who have multiple co-morbidities, making open-heart surgery a high-risk procedure which results in many people going untreated. When left unaddressed, TR can lead to debilitating conditions such as atrial fibrillation, heart failure and, ultimately, death.
Mike Dale, senior vice president of Abbott’s structural heart business, said: “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.
“Our novel TriClip therapy offers the best possible outcomes for people suffering from a debilitating condition and gives doctors even more options for customising repair of this complex anatomy.”
Recent data from the TRILUMINATE CE Mark study into the TriClip showed sustained symptomatic improvement, reduction in the severity of TR and improvement in functional status, demonstrating the benefits of the therapy as a safe treatment option for high-risk patients with symptomatic moderate or greater TR.
The TriClip G4 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.
The clip’s delivery system is designed specifically for the tricuspid valve with a steerable guiding catheter system, meaning physicians can independently grasp and effectively clip leaflets of the tricuspid valve to reduce the regurgitation. The latest design includes two new clip sizes, offering clinicians a total of four sizes to tailor the device to different patient anatomies.
Philipp Lurz, MD, PhD, professor and deputy head of cardiology at the Heart Center Leipzig, said: “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.
“This newest generation device further improves cardiologists’ ability to safely and effectively repair the tricuspid valve, which historically has been extremely challenging to treat.”
Kat Jenkins
This is a syndicated feed from Pharmafile
