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TransMedics - Model OCS Liver - Organ Care System
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.
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- 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.