Abbott's TriClip gains FDA approval for treating tricuspid regurgitation, offering a minimally invasive solution for 1.6 million affected Americans. Results show significant improvements in symptoms and quality of life.

United States: Abbott made a significant announcement on April 2, 2024, revealing that the U.S. Food and Drug Administration (FDA) has given the green light to their pioneering TriClip transcatheter edge-to-edge repair (TEER) system. This innovative device is specially designed to address tricuspid regurgitation (TR), commonly known as a leaky tricuspid valve. The FDA's decision comes on the heels of a recent recommendation from the Circulatory System Devices Panel of the Medical Devices Advisory Committee, where the vote of 13 to 1 with no abstentions confirmed that the benefits of TriClip outweighed its risks.

Tricuspid regurgitation affects more than 1.6 million individuals in the U.S., greatly impacting their quality of life. The TriClip system offers a safe and minimally invasive option for patients requiring tricuspid valve repair but who are not suitable candidates for surgery due to various reasons.

The TRILUMINATE Pivotal trial data showcased substantial improvements in patients' symptoms and quality of life after receiving TriClip, with these benefits sustained even after a year. TR occurs when the tricuspid valve fails to close properly, causing blood to flow backward in the heart. This condition can lead to severe symptoms such as fatigue and shortness of breath, and if left untreated, it can result in atrial fibrillation, heart failure, and even death.

TriClip works by using TEER technology to clip together a portion of the tricuspid valve's leaflets, allowing blood to flow correctly without the need for invasive open-heart surgery. Patients who undergo TriClip typically spend just one day in the hospital before returning home.

The FDA's approval was based on findings from the TRILUMINATE Pivotal trial, the world's first randomized controlled study comparing the TriClip system to medical therapy in individuals with severe TR at intermediate or greater risk for open-heart surgery. Results showed that 90% of patients experienced a significant improvement in their TR grade within 30 days, with the reduction sustained after a year. The safety profile was also impressive, with 98% of patients free from major adverse events within 30 days, coupled with a significant enhancement in quality of life.

TriClip, building on the same clip-based technology as Abbott's MitraClip device used for mitral regurgitation, has already been approved for use in over 50 countries, including Europe and Canada, since its initial CE Mark approval in 2020. The device has been successfully used to treat over 10,000 patients with TR.

Abbott's commitment to addressing structural heart disease is further demonstrated through their comprehensive portfolio of innovative therapies, such as the MitraClip, Amplatzer Piccolo Occluder for closing heart holes in infants, and Navitor transcatheter aortic valve implantation system for aortic stenosis. The company remains dedicated to advancing standards of care and meeting the unmet needs of patients, empowering them to lead fuller lives.

Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial, said, “The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues. With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker.”

Sandra Lesenfants, senior vice president of Abbott's structural heart business, Alexion, 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 U.S., we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions.”

According to TechSci Research, The FDA approval of Abbott's TriClip device marks a pivotal moment not only for patients suffering from tricuspid regurgitation (TR) but also for the healthcare market growth trajectory. This milestone is poised to have a significant impact on the healthcare market and Abbott's position within it.

The approval of TriClip opens a new avenue of treatment in the healthcare market, addressing a significant unmet need for patients with TR. With more than 1.6 million Americans affected by this condition, there is a substantial market for innovative solutions like TriClip. This approval expands Abbott's reach in the structural heart disease market, estimated to be worth billions globally.

Moreover, TriClip's approval is likely to boost Abbott's revenue and market share in the structural heart disease sector. With an already established MitraClip device treating mitral regurgitation, TriClip further solidifies Abbott's leadership in the field. As TriClip utilizes the same clip-based technology as MitraClip, the company can leverage its existing infrastructure and expertise, reducing costs and accelerating market penetration.

The approval also enhances Abbott's reputation as an innovative healthcare company. Being the first-of-its-kind device for TR, TriClip demonstrates Abbott's commitment to advancing medical technology and improving patient outcomes. This can attract more partnerships, collaborations, and investments, further fueling Abbott's growth.

Furthermore, the approval of TriClip has implications beyond the U.S. market. With approvals in over 50 countries, including Europe and Canada, TriClip's global market potential is substantial. Abbott's international growth is likely to see a boost as more patients around the world gain access to this innovative treatment.