The FDA has approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device used to preserve donated lungs that do not initially meet the standard criteria for lung transplantation, but which may be transplantable if there is more time to observe and evaluate the organ’s function to determine whether the lung is viable for transplantation.

Only 1 in 5 donated lungs meets the standard criteria for a donor lung and is transplanted into a recipient. In 2012, 1,754 lung transplants were performed in the United States and at the end of that year, 1,616 potential recipients remained on the waiting list.

The XPS received a Humanitarian Use Device (HUD) designation and was reviewed through the Humanitarian Device Exemption (HDE) pathway.

If additional time is needed to determine if a donated lung meets the standard criteria for lung transplantation, the XPS can be used to warm the donor lungs to near normal body temperature and continuously flush the lung tissue with a sterile fluid solution, called STEEN Solution, which preserves the lungs and removes waste products.

The XPS also ventilates the lungs, which oxygenates the cells and makes it possible for the transplant team to examine the lungs’ airways with a bronchoscope.

Donor lungs can stay in the machine for up to four hours; during this time the transplant team can examine the lungs and evaluate their function. If after further evaluation the lungs meet certain functionality criteria, and pass the transplant surgeon examination, they are transplanted into a recipient.