The Food and Drug Administration said approval of the XVIVO Perfusion System could lead to more successful transplants of lungs for people with cystic fibrosis and other respiratory diseases.
The device consists of a bubble-like chamber where the lungs are stored and connected to a series of pumps and filters that provide oxygen and a sterile cleansing solution. Lungs can be kept in the machine for four hours as doctors evaluate their suitability for transplant.
Only about one in five lungs donated today initially meet the medical criteria for transplantation. By giving doctors more time to examine the organs, FDA officials say more lungs may ultimately be transplanted. The device maker is based in Englewood, Colorado.