The FDA approval is based on results from TRILUMINATE trial, which showed that patients treated with TriClip system experienced improvement in the severity of their symptoms and quality of life, with benefits sustained at one year
TriClip is specifically designed to treat tricuspid regurgitation (TR). (Credit: MultiVu, a Cision company/Abbott)
US-based medical devices company Abbott has received the US Food and Drug Administration (FDA) approval for its TriClip transcatheter edge-to-edge repair (TEER) system.
TriClip is specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve, and leverages the same clip-based technology as Abbott’s MitraClip device.
The system is delivered through a vein in the leg and its TEER technology works by clipping together a portion of the leaflets, or flaps of tissue, to repair the tricuspid valve.
It also helps blood flow in the right direction without the need for open-heart surgery, allowing people to stay in the hospital for only one day to recover and return home.
TriClip represents an option for patients who continue to have persistent TR despite treatment with medical therapy and are not eligible for surgery, to improve their quality of life.
After receiving initial CE Mark approval in 2020, TriClip was approved in more than 50 countries, including in Europe and Canada, and has already been used to treat more than 10,000 people with TR.
Abbott’s structural heart business senior vice president Sandra Lesenfants 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 US, we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions.”
The FDA approval follows the recent recommendation of the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee, that its benefits outweighed the risks.
It is supported by the results from the TRILUMINATE trial, a randomised, controlled clinical study that assessed the safety and effectiveness of the TriClip compared to medical therapy.
In the study, 90% of patients treated with the TriClip system experienced a clear improvement in their TR grade, reducing from severe or higher to moderate or less, sustained at one year.
The study also showed a highly favourable safety profile, with 98% of patients being free of major adverse events, and significant improvement in quality of life at 30 days, said Abbott.
TRILUMINATE trial co-principal investigator Paul Sorajja 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.”