Abbott’s TriClip Receives CE Mark

Abbott’s TriClip Transcatheter Tricuspid Valve Repair System has received the CE mark and is now approved for use in Europe and other countries that recognize CE mark as a non-surgical treatment for people with a leaky tricuspid valve, a condition known as tricuspid regurgitation (TR). With the CE mark designation, TriClip device is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available in the world. The tricuspid valve, often referred to as the forgotten heart valve, has three leaflets that control the flow of blood between the two chambers on the right side of the heart. When those leaflets do not close properly, blood can flow in the reverse direction – known as regurgitation – forcing the heart to work harder. When left untreated, TR can lead to conditions such as atrial fibrillation, heart failure, and ultimately death. The condition is difficult to treat, however, and options for patients have historically been extremely limited.

TriClip builds upon the proven success of Abbott’s MitraClip device, which treats people with leaky mitral valves, or mitral regurgitation (MR). TriClip leverages the same clip-based technology as MitraClip but has a differentiated delivery system, designed specifically for delivery to the tricuspid valve. A new, steerable guiding catheter system adapts to the right side of the heart, where the tricuspid valve resides, enabling the physician to effectively grasp and clip the leaflets of the tricuspid valve. Additionally, the TriClip device is available in two different sizes (NT and XT) to accommodate different patient anatomies.