Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery

Inclusion Criteria: 1. Weight ≥15 kg; 2. Age ≥10 and ≤70 years; 3. MELD score of ≥24; 4. Documented liver failure; 5. Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements. Exclusion Criteria: 1. Cerebral Perfusion Pressure (CPP) as measured by an intracranial pressure (ICP) monitor.: 1. Patients ≥ 18 yrs of age with Cerebral Perfusion Pressures ≤40 mm Hg for one hour or longer. 2. Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer. 2. Concomitant disease including chronic congestive heart failure, vascular disease, emphysema, AIDS, cancer, acute fatty-liver disease, hepatitis due to herpes virus, Wilson's disease, or Budd-Chiari syndrome; 3. Portal hypertension; 4. Liver dysfunction due to trauma; 5. Hemorrhage or irreversible brain death; 6. Platelet count \<50,000/mm3 or reducing to \<80,000/mm3 over a 72 hour period; 7. Mean Arterial Pressures (MAP) ≤50 mm Hg for one hour or longer as measured by an indwelling arterial line, OR; patients ≤18 years old and whose MAP is ≤40 mm Hg for one hour or longer; 8. Vasopressor support exceeding 1.0 µg/kg/min of an alpha-adrenergic agent for one hour or longer; 9. Clinical or radiographic evidence of stroke or intracerebral bleeding; 10. Seizures uncontrolled by medication; 11. Acute myocardial infarction based on clinical and/or electrocardiographic evidence; 12. Lung disease defined by a PaO2 ≤ 60mm Hg or an FiO2 ≥0.6; 13. Pregnancy as determined by βhCG results; 14. ≤2 weeks postpartum; 15. Eligible for an open ELAD clinical trial