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: April 27, 2022
Approval Letter: Approval order
What is it?
The TransMedics Organ Care System (OCS) Heart System is designed to preserve donor hearts prior to transplantation. The system includes:
- A portable enclosure that warms the donor heart and provides it with oxygen and nutrients
- Heart preservation solution
The OCS Heart System was previously approved for the preservation of donation-after-brain-death donor hearts that could not be preserved using standard cold storage.
This approval expands the indications for use to include the preservation of donation-after-circulatory-death donor hearts, when the heart is recovered for use after all circulatory and respiratory functions of the donor have stopped.
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 metrics, such as temperature and pressure.
When is it used?
The OCS Heart is used by trained medical professionals to preserve and transport donor hearts.
What will it accomplish?
The OCS Heart System may allow doctors to make use of donor hearts that are currently not often used for heart transplants. This may 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, among patients who met study eligibility, 94 out of 100 people who received a donation-after-circulatory-death heart preserved using the OCS Heart System were alive at 6 months post-transplant. In comparison, 91 out of 100 recipients of a donation-after-brain-death heart preserved using the standard cold storage method were alive at 6 months post-transplant. In addition, 88 out of 100 donation-after-circulatory-death hearts preserved using the OCS Heart System were used for transplant.
When should it not be used?
The OCS Heart System should not be used for donor hearts with:
- Moderate to severe leakage of the heart valve between the main pumping chamber of the heart and the main artery to the body (aortic valve)
- Observed bruising
- Known unrepaired holes between the left and the right chambers of the heart
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Labeling Part 2
- PMA Database Entry
- Organ Care System (OCS) Heart System – P180051