Abbott announced that it received the European CE Mark for its TriClip Transcatheter Tricuspid Valve Repair System, a minimally-invasive device for tricuspid regurgitation repair.
Like many other valve repair devices, TriClip is designed for implantation using a minimally-invasive transcatheter procedure. Unlike other devices, however, TriClip works by clipping together a portion of the leaflets that make up the tricuspid valve. This reduces the backflow of blood in tricuspid regurgitation patients that is responsible for clinical symptoms and long-term cardiac sequela. TriClip is available in two different sizes.
The technology was validated in Abbott’s TRILUMINATE study, published in The Lancet in November 2019, which demonstrated that the device reduced severity of tricuspid regurgitation and resulted in increased functional capacity and quality of life at six months following implantation.
TriClip is based on Abbott’s existing MitraClip device for mitral regurgitation and uses the same clip-based technology, but with a delivery system specifically for the tricuspid valve.
“Tricuspid regurgitation is a highly prevalent, yet seldom treated disease, which is why this approval is a significant milestone for the healthcare community,” said Michael Dale, senior vice president of Abbott’s structural heart business, in a statement. “Our clip-based technology provides clinicians a life-changing, proven safe, simple, and effective option to treat people suffering from a crippling and life-threatening disease.”