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OrganOx metra® System - P200035

OrganOx metra® System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: OrganOx metra® System
PMA Applicant: OrganOx Limited
Address: Oxford Science Park, Magdalen Centre, Robert Robinson Avenue, Oxford OX4 4GA, UK
Approval Date: December 9, 2021
Approval Letter: Approval Order

What is it?

The OrganOx metra® System is designed to transport and preserve donor livers prior to transplantation. The system has three main components:

  • A reusable base unit that contains software, hardware, and a trolley or hardcover;
  • A sterilized, single use, disposable fluid management circuit; and
  • The solutions required for perfusion.

How does it work?

The OrganOx metra® System supplies donor livers with oxygen and nutrients by passing fluids through the liver (perfusion). The device also maintains donor livers at body temperature for up to 12 hours prior to transplantation.

When is it used?

The OrganOx metra® is used by trained medical professionals for the transport and perfusion of a donor liver.

What will it accomplish?

The OrganOx metra® may preserve the donor liver in a functional state for up to 12 hours.

When should it not be used?

The device is not to be used for more than 12 hours. The device should also not be used for livers from living donors, livers intended for split transplant, or for liver recipients requiring oxygen therapy, inotropic support, renal replacement therapy, multiple organ transplantation, and acute liver failure.

Additional information (including warnings, precautions, and adverse events):

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