First-Of-Its-Kind Device Repairs Leaky Tricuspid Heart Valve

Tricuspid regurgitation (TR), or a leaky tricuspid valve, arises when this valve fails to close properly, causing blood to flow backward in the heart. This can result in the heart overworking, leading to symptoms like fatigue and breathlessness that severely impact the quality of life. If left untreated, TR can lead to atrial fibrillation, and heart failure, and could be fatal. Now, an innovative, less invasive treatment solution is available for patients requiring tricuspid valve repair who may not be suitable for undergoing surgery.

Abbott’s (Abbott Park, IL, USA) first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system has been designed specifically for the treatment of TR. TriClip utilizes the same clip-based technology as Abbott's MitraClip device which was designed specifically to treat the tricuspid valve's complex anatomy. Administered via a vein in the leg, the TEER technology involves clipping parts of the valve's leaflets together to repair the tricuspid valve, helping to correct the blood flow direction without performing open-heart surgery. Typically, TriClip recipients may spend just a day in the hospital post-procedure before heading home. TriClip offers a valuable treatment alternative for patients whose symptoms or TR persist despite medical therapy and who are deemed unsuitable for surgical options, thus enhancing their quality of life.

The U.S. Food and Drug Administration (FDA) has approved TriClip, based partly on findings from the TRILUMINATE Pivotal trial, the world's first randomized, controlled study for assessing TriClip's efficacy and safety against medical therapy in severe TR patients at intermediate or higher risk for open-heart surgery. Results showed that 90% of TriClip-treated patients saw their TR grade improve from severe to moderate or less within 30 days – a benefit maintained after one year. The trial also highlighted an excellent safety profile, with 98% of patients being free of major adverse events by the 30-day mark and experiencing notable quality-of-life enhancements. TriClip is approved in over 50 countries, including Europe and Canada, following its initial CE Mark in 2020 and has treated more than 10,000 individuals with TR.

"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, senior vice president of Abbott's structural heart business. "With the addition of TriClip to our broad structural heart therapy offerings in the U.S., we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions."