The US Food and Drug Administration (FDA) has granted approval for Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system for leaky tricuspid heart valves.
This device is specifically designed to treat tricuspid regurgitation (TR), a condition where the heart's tricuspid valve fails to close properly, leading to backward blood flow.
The FDA's decision follows a positive recommendation from the Circulatory System Devices Panel of the Medical Devices Advisory Committee.
TR can cause severe health issues, including heart failure and death if left untreated.
TriClip offers a less invasive alternative to open-heart surgery for patients with persistent symptoms or those not suitable for surgical intervention.
It is delivered via a vein in the leg and works by clipping together parts of the valve's leaflets to reduce regurgitation.
Patients typically require only one day of hospitalisation post-procedure.
The approval by the FDA was supported by data from the TRILUMINATE Pivotal clinical trial, which showed significant improvements in TR grade and quality of life for patients treated with TriClip.
The trial indicated that 90% of TriClip recipients saw their TR grade reduced from severe to moderate or less within 30 days, a benefit that persisted after one year.
Additionally, the safety profile was highly favourable, with 98% of patients free of major adverse events for at least 30 days post-procedure.
Abbott's TriClip utilises the same clip-based technology as its MitraClip device, which has been used to treat over 200,000 patients with mitral regurgitation.
However, TriClip has been tailored to the tricuspid valve's unique anatomy.
Furthermore, the device has been approved in over 50 countries and has already been used to treat more than 10,000 people with TR since its initial CE Mark approval in 2020.
Abbott structural heart business senior vice-president Sandra Lesenfants said: “This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions.
“With the addition of TriClip to our broad structural heart therapy offerings in the US, we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions.”
Last month, the company received CE Mark for its Assert-IQ insertable cardiac monitor, which provides physicians with a new tool for diagnostic evaluation along with long-term irregular heart rhythm monitoring.
