OCS Liver PROTECT Continued Access Protocol

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).

Recipient Inclusion Criteria:

• Registered primary liver transplant candidate, male or female
• Age ≥ 18 years
• Signed (1) written informed consent document and (2) authorization to use and disclose protected health information

Exclusion criteria

• Acute, fulminant liver failure
• Prior solid organ or bone marrow transplant
• Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of > 3 mg/dl for > 2 weeks and/or requiring hemodialysis
• Multi-organ transplant
• Ventilator dependent
• Dependent on > 1 IV inotrope to maintain hemodynamics

Donor Inclusion Criteria

• Donor age ≥ 40 years, or
• Expected cross-clamp time ≥ 6 hours, or
• Donor after circulatory death (DCD) with age ≤ 55 years, or
• Steatotic liver > 0% and ≤ 40% macrosteatosis at time of retrieval

Donor Exclusion Criteria

• Living donors
• Liver intended for split transplants
• Positive serology (HIV, Hepatitis B surface antigen & Hepatitis C)
• Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
• Donor livers with macrosteatosis of > 40% based on retrieval biopsy readout.