OrganOx, a world leader in normothermic machine perfusion (NMP), today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its metra system.
The OrganOx metra is a fully automated NMP device for the preservation and transport of donor livers destined for transplantation. The marketing approval includes both livers from donors after brain death (DBD) and livers from donors after circulatory death (DCD).
Craig Marshall, OrganOx CEO, commented:
“We are thrilled with this news and excited to be able to bring our technology to the US, which we expect will increase the utilization of donor organs and thereby reduce waitlist mortality. To date, the metra has supported more than 1,200 liver transplants worldwide, with several individual centres in Europe having transplanted more than 100 donor livers using our system.
There is a clear unmet clinical need for our device in the US 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.”
Dr Stuart Knechtle, Executive Director of the Duke Transplant Center at Duke University School of Medicine and National Principal Investigator for the IDE Trial that supported PMA approval added:
“Through the IDE Trial we have seen the difference this technology can make to liver transplant outcomes. The biggest benefit of the metra is the ability to assess the function of the organ on the device, prior to committing to the transplant. This offers the potential to safely expand the pool of donor organs which would result in many more US patients receiving a liver transplant.”
For further information, please contact Andy Self; Global Commercial Director at OrganOx: email@example.com; +44 (0) 1865 632051