Paragonix Technologies
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as retrospective standard of care patients
GUARDIAN-Liver is a post-market, observational registry of adult and pediatric liver transplant recipient patients whose donor liver was preserved and transported within the LIVERguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria. About 2,000 male and female subjects meeting the study inclusion and exclusion criteria will be enrolled into the study at about 20 clinical sites. Candidates that fit the eligibility criteria and have had their donor li…
Inclusion Criteria: * Donor and donor liver matched to the recipient based upon institutional medical practice * Registered male or female liver transplant candidates Exclusion Criteria: * Donor and donor liver that do not meet institutional clinical requirements for transplantation * Living donors
The LIVERguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the liver. The intended organ storage time for the LIVERguard is up to 16 hours.