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FDA Devices Approval | 2024 | Abbott News | iPharmaCenter

April 02, 2024

Abbott Secures FDA Nod for Triclip, Novel Tool for Mending Faulty Tricuspid Heart Valve

Abbott revealed that the U.S. Food and Drug Administration (FDA) has given the green light to the company's pioneering TriClip transcatheter edge-to-edge repair (TEER) system tailored explicitly for addressing tricuspid regurgitation (TR), commonly known as a leaky tricuspid valve. This endorsement comes subsequent to the recent endorsement from the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention, that the advantages of TriClip surpassed the associated risks.


The tricuspid valve oversees the blood flow from the heart's right atrium to the right ventricle. TR occurs when the valve fails to close properly, leading to leakage and backward blood flow within the heart. TR imposes additional strain on the heart, resulting in distressing symptoms like exhaustion and breathlessness. If left unattended, TR can escalate to atrial fibrillation, heart failure, and eventually, fatality. For individuals enduring symptoms or persistent TR despite conventional medical therapy and are unsuitable candidates for surgery, TriClip presents an alternative capable of enhancing quality of life.


Administered via a vein in the leg, TriClip's TEER mechanism functions by clipping together a segment of the leaflets – or tissue flaps – to rectify the tricuspid valve, facilitating proper blood circulation without necessitating open-heart surgery. Typically, individuals undergoing TriClip require only a single day's hospital stay before recuperating and returning home.


During the approval process, the FDA scrutinized outcomes from the TRILUMINATE Pivotal trial, the world's maiden randomized, controlled clinical inquiry evaluating the safety and efficacy of the TriClip system in contrast to medical therapy in severe TR cases among individuals at intermediate or higher risk for open-heart surgery. The study revealed that 90% of TriClip recipients witnessed a notable enhancement in their TR severity, transitioning from severe or more severe to moderate or less within 30 days – a reduction sustained at the one-year mark. Moreover, the trial showcased a markedly favorable safety profile, with 98% of participants remaining free from major adverse events during the initial 30 days, coupled with a substantial improvement in quality of life.


TriClip harnesses the same clip-based technology as Abbott's renowned MitraClip device – which has served over 200,000 individuals with leaky mitral valves (mitral regurgitation) – albeit tailored explicitly to address the intricate anatomy of the tricuspid valve.


Since obtaining its initial CE Mark approval in 2020, TriClip has secured clearance for utilization in over 50 nations, including Europe and Canada. The device has already been employed to address TR in excess of 10,000 patients.


In conjunction with TriClip, Abbott's array of minimally invasive therapies includes technologies such as MitraClip and Amplatzer Piccolo Occluder (for closing heart holes in infants), alongside the Navitor transcatheter aortic valve implantation system (for treating aortic stenosis).

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