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 circulatory death (DCD).
OrganOx said metra is the first fully automated NMP system to garner FDA approval for preserving donor livers prior to transplant.
“We are thrilled with this news and excited to be able to bring our technology to the U.S., which we expect will increase the utilization of donor organs and thereby reduce waitlist mortality. To date, the metrahas supported more than 1,200 liver transplants worldwide, with several individual centers in Europe having transplanted more than 100 donor livers using our system,” OrganOx CEO Craig Marshall said in the release. “There is a clear unmet clinical need for our device in the U.S. where the situation is similar to Europe, with many patients dying on the waitlist and large numbers of donated organs that are not transplanted.
“With our device, we aim to make more livers available for transplantation to ensure that more patients can benefit from this life-saving procedure.”
