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: Organ Care System (OCS) Heart System
PMA Applicant: TransMedics, Inc.
Address: 200 Minuteman Road, Suite 302, Andover, MA 01810
Approval Date: September 3, 2021
Approval Letter: Approval Order
What is it? The TransMedics Organ Care System (OCS) Heart System is designed to preserve donor hearts prior to transplantation. This system includes a portable enclosure designed to warm the donor heart and,provide it with oxygen and nutrients, as well as a heart preservation solution.
How does it work? The OCS Heart System supplies donor hearts with oxygen and nutrients by passing fluids through the heart (perfusion). The device also measures and displays preservation parameters, such as temperature and pressure.
When is it used? The OCS Heart is used by trained medical professionals to transport donor-after-brain-death hearts when the cold storage method is unsuitable for these hearts (for example, out of body time longer than 4 hours).
What will it accomplish? The OCS Heart System may facilitate the use of donor hearts that could not be preserved using the cold storage method. This has the potential to increase the number of available donor hearts in the United States.
In a clinical study evaluating the safety and effectiveness of the OCS Heart System, about 95 out of 100 recipients of a donor heart preserved using the OCS Heart System were alive at 30 days post-transplant and 88 out of 100 recipients who were alive at 30 days post-transplant did not experience any severe donor heart dysfunction in the first 24 hours post-transplant. In addition, 81 out of 100 donor hearts preserved using the OCS Heart System were transplanted.
However, another clinical study comparing the OCS Heart System to the cold storage method found that patients in the OCS Heart System group had a lower survival rate, although most of the deaths were not related to the transplanted hearts. Therefore, the OCS Heart System should not be used on donor hearts that can be preserved using the cold storage method.
When should it not be used? The OCS Heart System should not be used with:
- donor hearts with moderate to severe leakage of the aortic valve (the heart valve between the main pumping chamber of the heart and the main artery to the body),
- donor hearts with observed bruising, or
- donor hearts with known unrepaired holes between the left and the right chambers of the heart.
Additional information (including warnings, precautions, and adverse events):