Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation

Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation

A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.

Inclusion Criteria:

• Registered male or female primary Liver transplant candidate
• Age ≥18 years old
• Signed: written informed consent

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 (>265 mmol/L) for >2 weeks and/or requiring hemodialysis;
• Multi-organ transplant;
• Ventilator dependent;
• Dependent on > 1 IV inotrope to maintain hemodynamics;
• Malignancy excluding HCC;
• Infection.