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For International Use Only:
SynerGraft is CryoLife’s patented decellularization technology that serves as the foundation for the next generation of implantable biological tissues.
The SynerGraft process reduces the presence of allogeneic donor cells associated with biological tissues, while maintaining the structural integrity of the biological matrix.
Implantation of the SynerGraft treated cardiac tissue reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, compared to standard processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced alloantibodies on the long-term durability, or long-term resistance to rejection by the patient.
Avoiding elevated PRA is important for patients receiving SynerGraft cardiac tissues as some may ultimately require a heart transplant. While the link between immune response and allograft tissue performance is still being debated, there is evidence that an elevated PRA poses a significant risk to future organ transplant patients. In these patients, an increased PRA can decrease the number of possible donors for subsequent organ transplants, and increase time on transplant waiting lists.