A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:~Donor age equal to or greater than 40 years old, or~Expected cross clamp time of 6 hours or greater, or~Donor after circulatory death (DCD) with age less than or equal to 55 years; or~Steatotic lever >0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)~A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.~All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.