Animal-derived tissues are widely used to manufacture bioprosthetic heart valves and cardiovascular patches. However, residual xenoantigens can trigger immune reactions and may affect the long-term performance of these devices.
Current approaches present several limitations: chemical fixation can mask rather than remove antigens, while decellularization does not completely eliminate xenoantigens bound to the extracellular matrix.
The invention provides a proprietary surface-treatment process that significantly reduces α-Gal in porcine and bovine cardiac tissues while preserving the structure and chemical composition of the extracellular matrix. The treatment has been successfully applied to native and decellularized cardiac tissues, as well as to material from a commercially available bioprosthetic heart valve.