TransMedics Gains Premarket Approval for its OCS Liver System for Transplantation

October 4, 2021

Andover, Mass.-based TransMedics has received premarket approval from the FDA for its OCS [organ care system] Liver for organs from liver donors.

The system, which is used to preserve and monitor hemodynamics and metabolic function, enables functional assessments of the donor livers prior to transplantation.

“The OCS Liver has the potential to save many lives by making liver transplants safer and by expanding the pool of available liver allografts,” said James Markmann, chief of the division of transplantation surgery at Massachusetts General Hospital and principal investigator in TransMedics’ OCS Liver PROTECT Trial.

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