OrganOx wins FDA PMA for its normothermic machine perfusion device

[Image from OrganOx]OrganOx announced today that it received FDA premarket approval (PMA) for its metra normothermic machine perfusion (NMP) system.

Oxford, England-based OrganOx designed its metra system as a fully automated NMP device for the preservation and transport of donor livers set for transplantation. The transportable device sustains donor livers in a functioning state for up to 12 hours, mimicking the environment of the human body with warm, oxygenated blood and nutrients between donation and transplantation.

The metra device can be used for liver grafts from donors less than or at 40 years old with less than or equal to 20 minutes of functional warm ischemic time. Liver grafts must come from donors with macrosteatosis at or below 15% in a near-physiologic, normothermic and functioning state.

According to a news release, premarket approval from the FDA includes both livers from donors after brain death (DBD) and livers from donors after circulat…

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