Bioprosthetic heart valves may have addressed some of the limitations of mechanical valves but still carry their own: gradual degeneration such as pannus growth, leaflet fibrosis and calcification, delamination of the connective tissue, and emergence of ruptures and perforations all eventually lead to valve failure (Kostyunin et al, 2020). While structural valve degeneration is under ongoing investigation, long term immune rejection and atherosclerosis-like tissue remodeling are emerging as potential causes. TRUE Heart Valve has been specifically designed to address these limitations. Non-calcific, non-immunogenic, 100% biological without any synthetic raw materials, and with tunable mechanical properties that mimic native valve performance, TRUE Heart Valve has been shown to support somatic growth in animal models as published in peer-reviewed publications.
Hydrodynamic performance assessment studies showed that transcatheter TRUE™ Heart Valve has 17±2% higher effective orifice area (EOA) compared to pericardial tissue valve in same valve design (Syedain et al, Heart Valve Society Presentation 2019).
Long term implantation of TRUE Valve technology in growing lambs for 52 weeks by the University of Minnesota inventors showed somatic growth, reduced calcification, and improved hemodynamic function compared to bioprosthetic control valves (Syedain et al, Science Translational Medicine 2021).
TRUE Valve technology provides high design flexibility. Valves are suitable for transcatheter delivery, can be designed as embedded structures on frames, and accommodate aortic, pulmonary, mitral, tricuspid, and venous sites. TRUE Tissue can be formed in a wide range of geometries with our scalable manufacturing process. Contact us to discuss how we can bring TRUE Valve to all the patients who can benefit from this technology.