Abbott has announced the launch of the TriClip transcatheter edge-to-edge repair (TEER) system in India for the treatment of tricuspid regurgitation (TR), a condition involving a leaky tricuspid valve.
The device is delivered through a vein in the leg and uses TEER technology to clip together a portion of the valve leaflets, or tissue flaps, to repair the tricuspid valve and help blood flow in the correct direction without the need for open-heart surgery. The technology builds on the platform used in the MitraClip device, which is used to repair leaky mitral valves on the left side of the heart. TriClip has a delivery system designed for navigating the right side of the heart. According to the company, patients receiving TriClip generally require one day of hospitalisation before discharge.
The tricuspid valve regulates blood flow from the heart’s right atrium to the right ventricle. Tricuspid regurgitation occurs when the valve does not close properly, causing blood to flow backwards in the heart. The condition can result in symptoms including fatigue and shortness of breath and, when untreated, may lead to atrial fibrillation and heart failure. Abbott stated that for patients who continue to experience symptoms or persistent TR despite medical therapy and are not considered suitable candidates for surgery, TriClip offers a treatment option that may improve quality of life and reduce hospitalisations related to heart failure.
According to the company, tricuspid regurgitation is increasingly being identified as a common but under-diagnosed heart valve condition in India, particularly among older adults and people with rheumatic heart disease, atrial fibrillation, pulmonary hypertension, or other valve disorders. Published reviews and echocardiography-based data indicate that clinically significant TR is frequently observed in routine cardiac practice and may progress over time if untreated.
“For far too long, patients living with tricuspid regurgitation have had limited treatment options that affected their quality of life. The introduction of TriClip in India represents an important advancement in care, offering a minimally invasive option that can improve symptoms and meaningfully impact patient outcomes,” said Sudheer Mirajkar, Country Manager for Abbott’s Structural Heart business in India. “With the addition of TriClip to our broad structural heart therapy options in India, we are continuing to bring life-enhancing benefits to patients with cardiovascular conditions.”
Abbott stated that the tricuspid valve has historically received less attention than other heart valves because symptoms can develop gradually and treatment options have been limited. The valve is located on the right side of the heart and has a wide and uneven structure, with anatomy varying across individuals. Its function is linked to the size and movement of the surrounding heart chamber, making treatment more complex.
The company said TriClip is supported by findings from the TRILUMINATE Pivotal trial, described as the first randomised, controlled clinical study evaluating the safety and effectiveness of the TriClip system against medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery. According to the findings reviewed by the U.S. Food and Drug Administration during the approval process, around 90 per cent of patients receiving the TriClip system recorded an improvement in TR grade from severe or higher to moderate or less at 30 days, with the reduction sustained at one year.
The study also reported that 98 per cent of patients remained free from major adverse events through 30 days and recorded improvements in quality of life. Abbott further stated that two-year findings from the TRILUMINATE Pivotal study showed that the TriClip system reduced heart failure hospitalisations by 28 per cent, along with improvements in tricuspid regurgitation and patient quality of life.