Donor-Lung Preservation Device Approved
TUESDAY, Aug. 12, 2014 -- 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.
Transplant is an option for people with severe lung problems, such as chronic obstructive pulmonary disease (COPD), cystic fibrosis or idiopathic pulmonary fibrosis, the FDA 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 agency explained. 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.
Visit the FDA for more about this approval.
Posted: August 2014