Abbott has announced that the US Food and Drug Administration (FDA) has approved the company’s TriClip transcatheter edge-to-edge repair (TEER) system for the treatment of tricuspid regurgitation (TR).
The approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to one, with no abstentions that the benefits of TriClip outweighed the risks.
“The US 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,” said Paul Sorajja (Minneapolis Heart Institute, Minneapolis, USA), co-principal investigator of the TRILUMINATE pivotal trial that compared TriClip to medical therapy in TR patients at intermediate or greater risk for surgery “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.”
Delivered through a vein in the leg, TriClip’s TEER technology works by clipping together a portion of the leaflets to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery.
As part of its approval process, the FDA reviewed findings from the TRILUMINATE pivotal trial, the randomised, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery.
In the study, 90% of patients who received the TriClip system experienced an 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.
“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 USA, we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions.”
TriClip leverages the same clip-based technology as Abbott’s MitraClip device, which has treated more than 200,000 people with mitral regurgitation, but was specifically designed to treat the tricuspid valve’s complex anatomy.
TriClip has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020. The device has already been used to treat more than 10,000 people with TR.
