The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.
The technology keeps lungs close to body temperature and continuously ventilate the tissue to keep cells oxygenated and allow doctors to examine airways. Donor lungs can stay viable in the XPS device for up to 4 hours while physicians assess function and prepare a patient.
XVIVO won permission to use the device with its already-approved Steen solution, which flushes lung tissue while it’s in the XPS system to remove waste products. In combination the products could help expand the pool of viable donor lungs by giving physicians more time to examine donor organs and by refreshing damaged tissue.
"This innovative device addresses a critical public health need," FDA Center for Devices & Radiological Health director Christy Foreman said in prepared remarks. "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."
XVIVO must conduct post-market surveillance and report adverse events and long-term patient outcomes as a condition of its FDA approval, the agency said.
