Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced that its TRIA valves have surpassed 200 patient life years in human recipients. Patient life years represent the cumulative time the valve has been implanted in patients, offering insight into the duration of its use and its impact on cardiac function over time.
TRIA valves are intended to improve the lifetime management of heart valve disease in patients. They incorporate a proprietary polymer – LifePolymer™ – that is used in computer-designed leaflets shown to resist calcification. The novel polymer material enables TRIA valves to be robotically produced, minimizing manpower and process, and maximizing product quality and precision. The TRIA valves have demonstrated excellent and stable hemodynamics clinically and have restored patient quality of life without requiring long-term use of anticoagulants.
“The LifePolymer material exhibits ideal biomaterial properties for flexible leaflets in a totally synthetic heart valve replacement, and it is encouraging to see the continued durability and performance in patients,” said David Grainger, Ph.D., Department Chair of Biomedical Engineering at the University of Utah and Chairman of Foldax’s Scientific Advisory Board. “Synthetic polymer leaflets in prosthetic cardiac valves hold the potential to reduce calcification and blood clotting while improving blood flow and durability.”
TRIA valves have been studied in clinical trials in the U.S. and India approved by the FDA and the DCGI.
“There are 120 active TRIA patients we continue to follow in our clinical studies, encompassing over 200 patient life years,” said Ken Charhut, Executive Chairman of the Board and CEO for Foldax. “Among them are early TRIA valve patients with almost five years of experience and many more who have had the valve for over four years. These positive, durable results give us confidence to expand our clinical study to transcatheter aortic valves (TAVR). We are excited to continue gaining clinical knowledge and make our novel TRIA valves available to more patients soon.”
TRIA heart valves are for investigational use only and is not available for commercial sale in the U.S. or any other region.
