Utah-based heart valve firm, Foldax has reported favorable early safety results in a trial of its TRIA mitral surgical heart valve designed using a novel polymer material for the treatment of conditions including rheumatic heart disease.
The 30-day trial of 67 patients ranging from 19 to 67 years of age at eight sites across India with many of the patients suffering from rheumatic heart disease, a heart condition liable to affect younger patients more than other valve conditions. Foldax says that results showed that its polymer-based heart valves met all current clinical standards for artificial valves at 30 days, with plans to reassess the patients at six-month and one-year marks.
Announced at the New York Valves, The Structural Heart Summit 2024, Foldax says that the results detail how its TRIA valves have shown stable hemodynamics in humans and have restored patient quality of life without requiring long-term use of anticoagulants.
Included as part of the results was a singular case study examining the first rheumatic heart disease patient treated with the TRIA mitral surgical valve in India. Commenting on her case, principal investigator for the study 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.”
Foldax’s TRIA heart valve is currently used for investigational use only and has not yet been authorised in any market. The announcement of the results follows after Foldax was able to raise $20m in capital aimed at funding the rollout of its TRIA device as well as the TRIA transcatheter aortic valve replacement (TAVR).
Research by GlobalData found that the global cardiac valve repair device market is estimated to grow to $303m by the end of 2024, up from $199.4m in 2023.
Presenting the results at the New York meeting, Isaac George, surgical director of the Heart Valve Center at Columbia University, said: “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.”
Elsewhere in the field of aortic valve replacements, the US Food and Drug Administration (FDA) has granted HighLife an investigational device exemption (IDE), for a pivotal trial of its trans-septal mitral valve replacement (TSMVR) system.
