FACTA technology has been scientifically proven to to boost up the biocompatibility of soft animal tissues used by the industry to manufacture medical devices of biologic origin. FACTA efficacy in inhibiting the triggering of inflammatory processes and immune responses was assessed in preclinical studies. FACTA demonstrated the ability to overcome the limits of current biomaterials in inhibiting tissue degradation, calcification, thrombogenicity and bacteria adhesiveness ensuring a well-acceptance of the prosthesis and optimising its clinical performance over time.
The implantation of a xenogeneic biological medical device cannot be considered as a definitive solution. All implantable bioprostheses are characterized by a non-optimal biocompatibility which limits their functionality over time.
Alpha-Gal is scientifically recognized as the most reactive xenogeneic molecule present in all mammalian tissues but humans, apes, and Old World monkeys. Since alpha-Gal is not present in humans, it triggers an explosive immune reaction. When a biologic heart valve prosthesis is implanted in a patient this reaction is moderate as the soft tissue composing the device is properly treated by the manufacturer to avoid hyperacute responses. Nevertheless, the alpha-Gal molecules are not completely inactivated leading to a mild but constant immune response over time that, together with a latent inflammation of the prosthesis, culminates with its degradation and mandatory substitution.
FACTA acts mainly, but not only, to inactivate alpha-Gal. It is also be considered a detoxification method for glutaraldehyde as well as a technology eligible to improve the animal tissue biocompatibility and hence greatly prolong the biological heart valve prostheses durability.
CD36 macrophages popolulation identified in brown color (HRP immunostaining) in original (A and B) pericardial commercial Bioprosthetic Heart Valve (BHV) leaflets after 1 month of implant in pig animal model. FACTA treated counterpart (C and D) does not report any presence of CD36 cells.
Structured thrombus formation in commercial pericardial Bioprosthetic Heart Valves (BHV) leaflets after 1 month of implant in pig animal model (A and B). The FACTA treated counterpart (C and D) does not report the presence of any thrombotic occurrences.
Von Kossa staining of untreated (A and B) and FACTA treated (C and D) commercial Bioprosthetic Heart Valve (BHV) leaflets after 1 month of follow-up in pig animal model. Widespread of microcalcifications affecting the internal portion of the leaflet are clearly recognizable in untreated samples (yellow arrows).
About 50% of the carboxylic and amino free groups of glutaraldehyde (GLA) in commercial bioprostheses are stabilized by the FACTA treatment, decreasing the propensity of GLA towards inflammatory processes and calcific deposition.