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  1. Device Approvals, Denials and Clearances

TransMedics OCS Lung System - P160013/S002

TransMedics OCS Lung System - P160013/S002

Image of TransMedics OCS Lung System

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: May 31, 2019
Approval Letter: Approval Order

What is it? The TransMedics OCS Lung System is designed to preserve donor lungs prior to transplantation. The TransMedics 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. Prior to transplantation, the device enables the transplant team to monitor and assess the donor lungs while they are being perfused.
The original PMA approval allowed the use of the device with only standard criteria donor lungs. This current approval expands the indications for use to include preservation of donor lung pairs initially deemed unacceptable for transplantation based on limitations of cold storage preservation.

How does it work? The TransMedics OCS Lung System works by supplying donor lungs with oxygen and nutrients through ventilation and warm 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. The TransMedics OCS Lung System is used for preservation of standard criteria donor lung pairs and for preservation of donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold storage preservation.

What will it accomplish? The TransMedics OCS Lung System has the potential to increase the number of available donor lungs by making a donor organ available for a given recipient that otherwise would not be considered an appropriate match (e.g., due to geographical distances). The device also may facilitate the use of donor lungs that physicians believe not to be "standard criteria," such as lungs from older donors or donation after circulatory death.

Compared to the standard of care cold storage method for preservation of donor lungs, the TransMedics OCS Lung System reduces the time during which the lungs lack blood and oxygen support outside of the body. In a clinical study to evaluate safety and effectiveness of preservation of donor lungs initially deemed unacceptable, the rate of Primary Graft Dysfunction Grade 3 (PGD3) within 72 hours post-transplantation was increased in patients transplanted with these types of lungs preserved by the TransMedics OCS Lung System. PGD3 is a severe form of acute lung injury that is associated with poor clinical outcomes. However, clinical outcomes, such as survival and rate of bronchiolitis obliterans syndrome (BOS) at 2 years post- transplantation, were similar when compared to the standard of care cold storage method. BOS is a common long-term complication after lung transplantation.

When should it not be used? The TransMedics OCS Lung System should not 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):

The long-term safety and effectiveness of the OCS Lung System will be evaluated in post-market studies.