SAN FRANCISCO, Sept. 28, 2019 /PRNewswire/ -- Abbott (NYSE: ABT) today 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 (TR). 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 data was presented earlier today at the 31st Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in San Francisco (September 25 -29). 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.
The tricuspid valve is located between the two chambers on the right side of the heart and is challenging to treat because of its location. A leaky tricuspid valve is a result of the valve's three leaflets not closing properly, and in severe cases this leaking can result in long-term complications such as atrial fibrillation, heart failure and, ultimately, death. Despite advancements in catheter-based devices for treating aortic and mitral valve disease, there are currently no commercially approved minimally invasive devices on the market to treat a leaky tricuspid valve, leaving few options available to patients with moderate to severe TR who are at high risk of experiencing complications with open-heart surgery.
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"Since we enrolled our first patient in the study, we have seen promise in this device for effectively treating people with tricuspid regurgitation," said Georg Nickenig, M.D., Ph.D., professor and chief, Department of Cardiology, University Hospital, Bonn, Germany, and lead investigator of the study. "The potential for a catheter-based option like Abbott's TriClip device is promising for long-term patient outcomes, and we look forward to continuing to share additional findings in the future."
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.