Abbott announces outcomes data for device to repair leaky Tricuspid heart valves
Abbott announced new data that suggest Abbott's investigational TriClip device may offer physicians an effective minimally invasive repair option for patients suffering from a leaky tricuspid valve, a condition also known as tricuspid regurgitation. For patients suffering from moderate to severe TR, the new data found treatment with TriClip was safe and associated with strong clinical improvement at six-months, including a reduction in TR and improvement in quality of life. The results build upon the initial 30 day data from the TRILUMINATE Feasibility Study, which suggested the promise of TriClip in treating people suffering from this difficult-to-manage structural heart disease. After six months, the TRILUMINATE Feasibility Study showed patients who received Abbott's TriClip device saw a number of benefits, including: Reduction of tricuspid regurgitation - Within the study, 87% of patients had a reduction in their TR at 6 months, with 57% of patients implanted having a TR classification of moderate or better vs. only 6% of patients with the same classification at the time of enrollment; 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 versus only 25% of patients receiving the same classification at the time of enrollment; Quality of life improvements - Patients receiving TriClip showed improved KCCQ scores and a reduction in symptoms that are associated with a reduced burden of their clinical condition and improved physical output. 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.