Abbott customizes TriClip heart valve system with upgraded EU approval

Abbott TriClip
Abbott's first version of TriClip device received European approval in early April 2020. The device has not yet been approved in the U.S. (Abbott)

Abbott won European approval for the latest generation of its TriClip system, the first transcatheter-based repair device designed to stem leaks in the heart's tricuspid valve.

Separating the heart’s right atrium and ventricle, which push blood to the lungs to load up on new oxygen, the tricuspid valve presents particular anatomical challenges compared to the heart’s left-side mitral valve: It opens and closes a set of three flaps, rather than two. Because of that complexity, patients with tricuspid valve problems have had fewer treatment options.

The company’s top-selling MitraClip helped treat mitral regurgitation, or the backflow of blood through the valve with each heartbeat. One of the most common valve diseases, regurgitation ultimately forces the heart to work harder than it should. The device clips the two leaflets together at the center, creating two smaller openings that can form a tighter seal.

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The upgraded TriClip works in the same way, but allows clinicians to tailor the procedure to each patient’s unique valve using a range of four sizes to hold together a portion of its flaps. It also includes a new, steerable delivery system that lets surgeons independently grasp leaflets before fastening.

The CE mark for the new version, dubbed TriClip G4, comes just one year after it was first cleared in Europe. It also recently received approval in Canada, but the device has not yet been approved in the U.S.

RELATED: Abbott nets EU approval for next-gen MitraClip heart valve repair system

Describing tricuspid regurgitation as “the most undertreated valve issue,” the senior VP of Abbott’s structural heart business, Mike Dale, said in a statement that the TriClip aims to offer more options for the debilitating condition, which when left untreated can lead to atrial fibrillation, heart failure and death.

The condition is typically found in older people with other health problems that may make open-heart surgery too risky. For those patients, transcatheter approaches like the TriClip’s could be a preferable option.