TransMedics, Inc. TransMedics OCS Lung System - P160013
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) Lung System
PMA Applicant: TransMedics, Inc.
Address: 200 Minuteman Road, Suite 302, Andover, MA 01810
Approval Date: March 22, 2018
Approval Letter: P160013 Approval Letter
What is it? The TransMedics OCS Lung System is designed to preserve donor lungs prior to transplantation. The OCS Lung System includes a portable enclosure with mechanical and electrical components used to warm, ventilate and perfuse the lungs (i.e., supply with fluid), as well as a lung preservation solution combined with packed red blood cells.
How does it work? The OCS Lung System works by supplying donor lungs with oxygen and nutrients through ventilation and perfusion. The device also measures and displays preservation parameters, such as temperature and pressure.
When is it used? The TransMedics OCS Lung System is used by trained medical personnel during the retrieval and transportation of donor lungs.
What will it accomplish?
Compared to the standard of care cold storage method for preservation of donor lungs, the OCS System reduces the time during which the lungs lack blood and oxygen support outside of the body. In a clinical study that compared the OCS System to cold storage, a lower rate of Primary Graft Dysfunction Grade 3 (PGD3) within 72 hours post-transplantation was observed in patients transplanted with lungs preserved by the OCS System. PGD3 is a severe form of acute lung injury that is associated with poor clinical outcomes. Other clinical outcomes, such as survival and rate of bronchiolitis obliterans syndrome (BOS) at two years post-transplantation, were similar between the two study groups. BOS is a common long-term complication after lung transplantation.
When should it not be used?
The TransMedics OCS Lung System cannot be used with donor lungs that have suffered moderate to severe traumatic injury with air leak, as seen on radiological studies, bronchial examination or final visual assessment in donor’s chest.
Additional information (including warnings, precautions, and adverse events):
Safety and effectiveness of the TransMedics OCS Lung System for marginal/extended criteria lungs, including donor lungs subjected to extended preservation times, have not been demonstrated.
The long-term safety and effectiveness of the OCS Lung System will be evaluated in post-market studies.
Summary of Safety and Effectiveness Data and labeling are available online: