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Thursday, July 7, 2022

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OrganOx Receives FDA Approval for its Liver Normothermic Machine Perfusion System

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 centers 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.”

Note to editors

FDA approved Indications for Use for metra:

The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.

The OrganOx metra device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) ≤40 years old, with  ≤20mins of functional warm ischemic time (time from donor systolic blood pressure <50mmHg), and macrosteatosis ≤15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.

About metra:

The OrganOx metra is the world’s first fully automated NMP system to receive FDA approval for the preservation of donor livers prior to transplant. The device mimics the environment of the human body by providing warm, oxygenated blood and nutrients to the donor liver in the crucial time between donation and transplantation. Through developing the metra, OrganOx has enabled transplant teams to objectively assess the function of a donor liver before a transplant, something which is impossible with ice box storage. This is particularly important when a donor liver is identified as ‘marginal’, when there is uncertainty as to whether it will function following transplant. The metra has supported more than 1,200 liver transplants globally.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.