Successful Completion of 300 Patient US FDA Pivotal Trial for Expanded Criteria and DCD Donor Livers.
A prospective, pivotal, randomized trial to evaluate the effectiveness of the OCS Liver to preserve and assess donor livers intended for transplantation.
Incidence of Early Liver Allograft Dysfunction (EAD) [ Time Frame: 7 days ]
Incidence of liver graft related Serious Adverse Events (SAEs) [ Time Frame: 30 days ]
The OCS is designed to enable surgeons to transplant more organs from the available donor pool and to achieve better procedural outcomes.