Minimally Invasive Clip Supports Tricuspid Valve Repair

The Abbott (Abbott Park, IL, USA) TriClip System includes three components: the TriClip device itself, a cobalt-chromium clip coated in polyester to promote tissue growth, which clamps to the leaflets of the tricuspid valve, holding them together; a steerable guide catheter that adapts to the right side of the heart; and the percutaneous venous access delivery system, which includes the clip, attached to a highly maneuverable delivery catheter, with all controls at the proximal end. The TriClip is available in two different sizes (NT and XT) to accommodate different patient anatomies.

The device is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve in order to reduce blood backflow. This allows the heart to pump blood more efficiently, relieving symptoms of TR and improving the patient's quality of life. In addition, since the heart beats normally during the procedure, the procedure does not require a heart-lung bypass machine. The TriClip System has received the European Community (CE) Mark of approval.

“Tricuspid regurgitation is a highly prevalent, yet seldom treated disease, which is why this approval is a significant milestone for the healthcare community. TriClip has the potential to fill a treatment gap and transform how doctors are able to help people with tricuspid regurgitation,” said Michael Dale, senior vice president of Abbott's structural heart business. “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.”

“Patients suffering from severe tricuspid regurgitation are extremely ill and have very few treatment options,” said Professor Georg Nickenig, MD, PhD, chief of the department of cardiology at University Hospital Bonn (Germany), and lead investigator of the TRILUMINATE trial, which generated strong data that helped lead to the CE Mark of TriClip. “Abbott's TriClip could profoundly impact how physicians treat these patients. The therapy is backed by data proving safety and performance, durability, and improved patient quality of life.”

The tricuspid valve separates the right atrium of the heart from the right ventricle, preventing blood from flowing from the ventricle back into the atrium. Diseases of the tricuspid valve are much rarer than those of the mitral valve, its counterpart in the left half of the heart. Tricuspid insufficiency, leading to TR, leads to build-up of blood in the ventricle and the veins causes increased pressure on these organs, resulting in water retention in the legs and abdomen, liver damage, and potential atrial fibrillation (AF). People with TR are typically older and suffer from multiple co-morbidities, making open-heart surgery a high-risk procedure.