Symptom improvement. Patients receiving TriClip had reduction in their symptoms, with 87% of patients implanted with TriClip being classified as NYHA functional class I/II at six months vs. only 25% of patients receiving the same classification at the time of enrollment. (NYHA is a classification of functional limitations resulting from cardiac disease.)
Quality of life improvements. Patients receiving TriClip showed improved KCCQ (Kansas City Cardiomyopathy Questionnaire) scores and a reduction in symptoms that are associated with a reduced burden of their clinical condition and improved physical output.
"There are currently no commercially approved minimally invasive devices on the market to treat a leaky tricuspid valve; the advancements shown in the TRILUMINATE Feasibility study offer hope for people suffering from this difficult-to-manage and difficult-to-treat structural heart disease," said Neil Moat, M.D., chief medical officer of Abbott's structural heart business. "We have seen the need for a safe and effective device to treat the tricuspid valve without open heart surgery, so we have focused efforts to support this patient population."
The TRILUMINATE Feasibility study was a prospective, single-arm, multi-center study, which investigated the performance of Abbott's proven clip-based repair technology using the tricuspid valve repair system, TriClip, in 21 sites across the U.S. and Europe.
TriClip builds upon the proven success of Abbott's clip-based MitraClip technology, which treats people with leaky mitral valves, or mitral regurgitation (MR). TriClip repairs the tricuspid valve without the need for an invasive surgical procedure and is delivered to the heart through the femoral vein, a blood vessel in the leg. The device works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood, allowing the heart to pump blood more efficiently, and therefore relieving symptoms of TR and improving patient quality of life.
Abbott's TriClip™ is an investigational device only.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
SOURCE Abbott
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