Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced positive 30-day results from a prospective, multicenter, single-arm, clinical study of the TRIA™ mitral surgical heart valve with LifePolymer™ conducted in India. At 30 days following surgery, TRIA demonstrated favorable safety and hemodynamics, consistent with long-established standards for heart valves. The results were presented last week at the New York Valves: The Structural Heart Summit 2024 by Isaac George, M.D., Surgical Director of the Heart Valve Center at Columbia University.
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, increasing manufacturing efficiency and maximizing product quality and precision. The TRIA valves have shown excellent and stable hemodynamics in humans and have restored patient quality of life without requiring long-term use of anticoagulants where clinically indicated.
“The LifePolymer material is uniquely formulated for heart valves and has been shown in animal studies to resist calcification, which can lead to stiffening leaflets that restrict blood flow through the valve,” said Dr. George. “Now, in the India study, imaging of the TRIA mitral surgical valve in humans at 30 days shows no sign of calcifying or deteriorating leaflets. A durable non-animal tissue heart valve that may not require long-term anti-blood clotting medication could be transformative in providing new options for patients suffering from mitral valve disease,” he said.
The TRIA mitral surgical valve study enrolled 67 patients ranging from 19 to 67 years of age at eight sites across India. A majority of the enrolled patients were females suffering from rheumatic heart disease, which affects a younger patient population than many other valve diseases. It is the largest clinical evaluation of a polymer heart valve in humans anywhere in the world. Patients will be assessed at six months and one year for safety, hemodynamic performance, and durability.
The New York Valves meeting also featured a challenging case study on the first rheumatic heart disease patient treated with the TRIA mitral surgical valve in India and an innovation presentation on the TRIA valve platform. Additional technical and clinical presentations on the TRIA mitral surgical valve and TRIA transcatheter aortic valve replacement (TAVR) were given at the International Society for Minimally Invasive Cardiac Surgery (ISMICS) conference in Athens, Greece earlier this month.
“We are encouraged by the strong clinical outcomes we are seeing with our patients in the Indian trial,” said Kaushal Pandey, MD, with P.D. Hinduja Hospital in Mumbai, India, principal investigator of the Indian study. “In the case study I presented at the New York Valves meeting, the patient is a young female of childbearing age. The potential to provide this patient, and others, with a durable heart valve that doesn’t require long-term use of blood thinners and may therefore provide her with the opportunity to pursue a family, is exciting and is something she cannot experience with currently available commercial mitral heart valves without risk of future operations.”
