OrganOx Gets Premarket Approval for its Liver Perfusion Device

December 30, 2021

OrganOx has been granted premarket approval by the FDA for its metra system, an automated device for the preservation and transport of donor livers destined for transplantation.

The approval was supported by results from more than 1,200 liver transplants worldwide, with several individual centers in Europe having transplanted more than 100 donor livers using the system, the UK-based company said.

The system’s biggest benefit is the ability to “assess the function of the organ on the device prior to committing to the transplant,” said Stuart Knechtle, executive director of the Duke Transplant Center at Duke University School of Medicine and principal investigator for the trial that supported the FDA approval.

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