FDA Approves Abbott’s TriClip Heart Valve Repair Device

The US Food and Drug Administration (FDA) on Tuesday, April 2, 2024, approved Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system for use in leaky tricuspid heart valves. The device was approved for use in patients with a potentially fatal heart disease. This is coming months after its rival Edwards Lifesciences' device was given a nod by the regulators. 

Abbott’s TriClip device is specifically designed to treat tricuspid regurgitation (TR), a condition that involves the failure of the tricuspid valve (the valve separating the right lower chamber of the heart from the right upper chamber) to close properly which leads to backward flow of blood.

TR is mostly common in older individuals with multiple co-morbid conditions including high blood pressure in the heart or lung and irregular heartbeat. These individuals are usually at a high risk of complications, and even death if open-heart surgery is done. However, if left untreated, TR can lead to severe health issues including heart failure and death.

TriClip is a less invasive treatment option

Since open-heart surgery is risky for patients with TR, Abbott’s TriClip provides a less invasive alternative for patients with persistent symptoms and those not suitable for surgical intervention. The device is delivered through a vein in the leg (the femoral vein), guided, and works by clipping parts of the valve’s leaflets together to lower regurgitation. 

According to government data estimates, around 1.6 million Americans are suffering from the condition. The decision by the FDA to approve the device follows a positive recommendation by the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The approval was also supported by data from the TRILUMINATE Pivotal clinical trial where it improved the quality of life and TR grade of the patients significantly.

During the trial, 90% of patients who received TriClip saw their TR grade drop from severe to moderate or less in 30 days. The benefits continued after a year. Also, the device recorded a high safety profile, with 98% of patients being free of major adverse events for at least 30 days after the procedure. 

In February, Edwards Lifesciences received approval for a device that replaces the tricuspid valve. Besides the use of medical devices, diuretic drugs are also used for managing the condition. The drug leads to frequent urination by the patient to prevent fluid buildup in the body.

"The key message to remember here is that patients now have options," said Nadim Geloo, Senior Director of Medical Affairs at Abbott's Structural Heart Division.

Abbott’s TriClip is an evolution of a previously available device

Abbott’s TriClip uses a clip-based technology that closely resembles its MitraClip device. MitraClip has been used to treat over 200,000 patients with mitral regurgitation. However, the TriClip has been designed to fit the unique anatomy of the tricuspid valve.

Abbott’s TriClip solution for TR has been approved in over 50 countries and has been used to treat over 10,000 people since its initial CE Mark approval in 2020. The company has grouped it in its “Fab 5” devices which are expected to drive sales growth in the coming years.

“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,” said Sandra Lesenfants, Abbott structural heart business senior vice-president.

“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.”