OCS Liver PROTECT Continued Access Protocol

Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.

Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

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:

1. Donor age equal to or greater than 40 years old, or
2. Expected cross clamp time of 6 hours or greater, or
3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or
4. 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.