Abbott obtains CE mark for tricuspid valve repair device
20 April 2021
Abbott has received CE Mark for its minimally invasive tricuspid heart valve repair device, TriClip Transcatheter Tricuspid Valve Repair System, making it available for treating tricuspid regurgitation (TR) in Europe.
The clip-based therapy, called TriClip G4, is a non-surgical heart valve repair option for TR treatment which allows doctors to customise valve repair according to patient anatomy.
TriClip possesses an accurate and steady delivery system made specifically for navigating the right side of the heart.
It is transported to the heart using a catheter inserted through the femoral vein in the leg and clips together parts of the tricuspid valve leaflets to reduce the backflow of blood.
As TriClip has a differentiated delivery system made for this valve and a steerable guiding catheter system, clinicians can independently clutch and efficiently clip leaflets of the valve to decrease regurgitation.
The device has two new clip sizes and a total of four sizes available, which allows clinicians to customise the device according to patient anatomy.
Abbott structural heart business senior vice-president Mike Dale said: “TR 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.
“Our novel TriClip therapy offers the best possible outcomes for people suffering from a debilitating condition and gives doctors even more options for customising repair of this complex anatomy.”
According to data from the Triluminate CE Mark study of TriClip, sustained symptomatic improvement, reduced TR severity and betterment in functional status were observed, all of which indicate the benefits of the therapy. The study also validated TriClip as a safe and durable treatment option for high-risk patients with symptomatic moderate or greater TR.
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