FDA expands use of device that keeps donor lungs viable
The portable TransMedics OCS Lung System helps physicians evaluate and improve the condition of donor lungs. Each organ is warmed and supplied with fluid, oxygen and nutrients.
Recently, the U.S. Food and Drug Administration approved expansion of the device’s use to include donor lungs previously deemed unacceptable, for reasons including geographical distance and advanced age of donor. This expansion should both increase the number of lungs deemed viable for transplant and offer new ways to utilize the donated organs.
“Bridging the divide between a donor and a recipient has always been at the cornerstone of transplantation,” said Gabriel Loor, M.D., surgical director of the lung transplant program at Baylor St. Luke’s Medical Center and a participant in clinical trials to expand usage of the OCS Lung System.
Loor estimated that 80 percent of the donor organs offered to any one institution are not utilized, whether it be due to geographical distance, the age of the donor or the function and mode of the organ.
“It doesn’t necessarily mean that they are not good organs to use,” he said. “It just means that it would be nice if we had a little bit more information on them before we committed our recipients to a transplant with them.”
As a result of the OCS Lung System’s recent trials, clinicians are now able to safely use organs that, ordinarily, would have been rejected, Loor said. “I can place the organ on this device, evaluate it for several hours and have a glimpse of how it will function in the recipient,” Loor said.
Beyond that, he added, the device offers a huge opportunity to push lung transplantation in new directions.
“Many of us believe that now we have an ideal setting to manipulate the organ,” Loor said. “Maybe administer gene therapy, stem cells, anti-inflammatory drugs. Maybe we can change the blood type of the organ and offer more organs to more recipients. Maybe we can genetically modulate the organ so it doesn’t reject. We really believe that we have a platform that we need to start looking at more creative ways to utilize for the advancement of quality organs and the quantity of organs.”