Abbott (NYSE:ABT) announced today that it received CE mark approval for its next-generation TriClip transcatheter tricuspid valve repair system.
The company touts the TriClip as a first-of-its-kind, minimally invasive tricuspid heart valve repair device for treating tricuspid regurgitation (TR), according to a news release.
Abbott Park, Ill.–based Abbott’s clip-based therapy is a non-surgical heart valve repair option specifically designed for treating TR by allowing physicians to tailor repair of the valve to each patient’s unique anatomy. When unaddressed, TR can lead to Afib, heart failure and potentially death.
TriClip was specifically designed to treat the tricuspid valve’s complex anatomy, offering precise and stable delivery engineered for navigating the right side of the heart.
In the Triluinate CE mark study, TriClip demonstrated sustained symptomatic improvement, reduction in the severity of TR and improvement in functional status, proving to be a safe and durable treatment for high-risk patients with symptomatic, moderate or greater TR.
The clip is delivered to the heart through a catheter inserted in the femoral vein in the leg and treats TR by clipping together a portion of the tricuspid valve’s leaflets to reduce the backflow of blood. It has a differentiated delivery system and a steerable guiding catheter system. The latest iteration includes two new clip sizes, bringing Abbott’s total offering to four sizes for tailoring to specific patient anatomies.
“Tricuspid regurgitation is considered the most undertreated valve issue, and our newest generation device to address it is the result of our unwavering commitment to restore health and improve the quality of life for patients with structural heart disease,” Abbott structural heart business SVP Mike Dale said in the release. “Our novel TriClip therapy offers the best possible outcomes for people suffering from a debilitating condition and gives doctors even more options for customizing repair of this complex anatomy.
The TriClip also received authorization from Health Canada yesterday, further broadening its reach.