(NEW YORK) — The U.S. Food and Drug Administration on Tuesday approved a donor lung preservation device that could result in more viable lung transplants.
In a statement on Tuesday, the FDA said that it had approved the XVIVO Perfusion System with STEEN Solution — a device that it says preserves donated lungs “that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function.” The FDA notes that 1,754 lung transplants were performed in 2012, but 1,616 potential recipients remained on a waiting list for lung transplants at the end of that year.
Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, called the device “innovative,” noting that it “addresses a critical public health need.”
By keeping potential donor lungs at normal body temperatures and continuously flushing the lung tissue with a sterile fluid solution, the XVIVO Perfusion System preserves the lungs and removes waste products while doctors can determine if the lung is viable for transplant.
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Jackie Wattles, CNN