Product Name: Organ Care System (OCS) Liver
PMA Applicant: TransMedics, Inc.
Address: 200 Minuteman Road, Suite 302, Andover, MA 01810
Approval Date: September 28, 2021
Approval Letter: Approval Order
What is it?
The TransMedics Organ Care System (OCS) Liver is used to preserve donor livers prior to transplantation. This system includes a portable enclosure designed to warm the donor liver, provide it with oxygen, nutrients, and blood, and collect bile from the donor liver.
How does it work?
The OCS Liver supplies donor livers with blood, oxygen, and nutrients by passing fluids through the liver (perfusion). The device includes bile salts, which are added to the perfusion fluid, and a bag for collecting bile from the liver. The device also measures and displays temperature, pressure, and flow rates. The transplant surgeon may use this information to help make a decision about whether a liver should be transplanted into a patient.
When is it used?
The OCS Liver is used by trained medical professionals to receive and transport donor livers.
What will it accomplish?
A clinical study compared the use of the OCS Liver System with cold storage and found fewer incidents of a post-transplant complication (early allograft dysfunction, or EAD) in patients who received livers preserved by the OCS Liver. Clinical outcomes, such as 1-year survival and length of hospital and intensive care unit stays, were similar between the two study groups.
When should it not be used?
The TransMedics OCS Liver should not be used with:
- donor livers that have suffered moderate to severe traumatic injury,
- donor livers with active bleeding (hematomas),
- split liver transplantations, or
- livers with unusual or accessory blood vessels providing blood flow to the liver.