HomeIH InterestsFDA Panel Votes to Approve TransMedics Device

FDA Panel Votes to Approve TransMedics Device

On Thursday the FDA’s Gastroenterology & Urology Devices panel voted in favor of approving TransMedics’ Organ Care System for the transportation of donor lungs to waiting transplant recipients. The portable system enables organ perfusion, ventilation and monitoring and is intended to preserve donor lungs in a near physiologic, ventilated,and perfused state for transplantation. As TransMedics says on their website, their device “[simulates] the conditions of the human body and [allows] the organ to function as it normally does” and is an alternative to standard cold transport. The OCS has the potential to increase the amount of time the organs are viable and allow the transplant surgeon to assess organ function outside the body, among other benefits.

The panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, according to a report from MassDevice. While the FDA is not required to follow the recommendation of the panel, it usually does.

TransMedics is conducting clinical trials to test the device for the transport of the heart and liver. These trials will be used to support U.S. market approval. The OCS Heart and OCS Lung devices are CE-marked and available in Europe, Australia and Canada.