FDA Approves Donor-Lung Preservation Device
Technology may lead to more transplants, FDA says
WEDNESDAY, Aug. 13, 2014 (HealthDay News) -- The XVIVO Perfusion System has been approved by the U.S. Food and Drug Administration to help preserve donor lungs that ultimately may be used for transplant, the agency said Tuesday in a news release.
The device is expected to be used to preserve lungs that initially may not meet transplant criteria but could be used after doctors have been given more time to evaluate the organ, the agency said. The just-approved device can be used to warm donor lungs to the appropriate temperature and flush lung tissue with a sterile solution called STEEN. The device also provides oxygen to the donor organ's cells for up to four hours.
Device manufacturer XVIVO Perfusion, based in Englewood, Colo., will be required to conduct a post-approval study of the device's long-term effects and any adverse reactions, the FDA said.
"This innovative device addresses a critical public health need," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a statement. "With this approval, there may be more lungs available for transplant, which could allow more people with end-stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant."