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 Healthcare major Abbott has announced the launch of TriClip transcatheter edge-to-edge repair (TEER) system, a device specifically designed for the treatment of heart valve condition tricuspid regurgitation (TR), in India.
The tricuspid valve controls blood flow from the heart’s right atrium to the right ventricle and TR occurs when the valve doesn’t close properly, causing a leak and allowing the blood to flow backward in the heart. The condition can force the heart to work harder, causing debilitating symptoms such as fatigue and shortness of breath.
When left untreated, TR can lead to atrial fibrillation (irregular heartbeat) and heart failure. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents an option that can improve a person’s quality of life and reduce hospitalizations for heart failure.
TriClip's TEER technology, delivered through a vein in the leg, works by clipping together a portion of the leaflets – or flaps of tissue – to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. The device leverages the technology and robust body of evidence from the MitraClip device, the minimally invasive option to repair leaky mitral valves, which occurs on the left (opposite) side of the heart.
It has a specialized delivery system engineered for navigating the right side of the heart. On average, people who receive TriClip only need one day in the hospital before they recover and can return home, said the company.
“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,” he added.
The company said that the clinical study on the device was reviewed by the US Food and Drug Administration as part of its approval process in US and in the findings, approximately 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year.
"The trial also demonstrated a highly favourable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life. Two-year findings from the Triluminate Pivotal study showed the Abbott TriClip system reduced heart failure hospitalizations by 28%, and significant improvements in tricuspid regurgitation and quality of life," it added.
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