Polymer heart valve developer Foldax said that its TRIA mitral surgical heart valve has shown positive 30-day results in a clinical trial conducted in India.
TRIA valves are designed to enhance the lifelong management of heart valve disease in patients. They are integrated with a proprietary polymer called LifePolymer, generally used in computer-designed leaflets shown to resist calcification.
At 30 days post-surgery, the TRIA mitral surgical heart valve displayed favourable safety and haemodynamic performance in the prospective, multicentre, single-arm clinical trial.
The results were consistent with well-established benchmarks for heart valves.
The results were presented at the New York Valves: The Structural Heart Summit 2024 by Isaac George, surgical director of the Heart Valve Center at Columbia University.
LifePolymer allows TRIA valves to be manufactured robotically, enhancing production efficiency while optimising product quality and precision.
Human trials have showcased the stable haemodynamic performance of TRIA valves. The device effectively restored patients’ quality of life, often without the necessity of long-term anticoagulant usage when clinically indicated.
Study principal investigator Kaushal Pandey said: “We are encouraged by the strong clinical outcomes we are seeing with our patients in the Indian trial. 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.”
The TRIA mitral surgical valve study enrolled 67 patients aged 19 to 67. Most of the patients were females with rheumatic heart disease.
The enrolment was completed in November 2023 across eight sites in India.
In addition, the study is said to be the largest clinical assessment of a polymer heart valve conducted in humans worldwide.
These patients will undergo evaluations for safety, haemodynamic performance, and durability over six months and one year.
