Metabolic Substitutes: Bioartifical Liver, Pancreas and Kidney Devices

Author: Miriam C. Provost
Office of Device Evaluation
Center for Devices and
Radiological Health

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Table of Contents

  1. Metabolic Substitutes: Bioartifical Liver, Pancreas and Kidney Devices
  2. Tissue-Engineered Metabolic Substitutes
  3. Bioartifical organs are considered “Combination Products”
  4. Bioartificial Liver Devices
  5. Circe Biomedical Bioartificial Liver System
  6. Excorp Medical Bioartificial Liver Support System
  7. Clinical Trials of Bioartifical Liver Systems
  8. FDA Considerations for Bioartifical liver systems
  9. Bioartifical Pancreas Devices
  10. Bioartifical Pancreas Device
  11. Bioartifical Pancreas Device: Results
  12. Encapsulated Islets
  13. Results from Phase I study of encapsulated human islets
  14. Bioartificial Pancreas Devices: FDA considerations
  15. Bioartificial Pancreas Devices: FDA considerations
  16. Bioartificial Renal Tubule Device
  17. Bioartificial Renal Tubule Device

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