The FDA has approved the XVIVO Perfusion System (XPS) with STEEN Solution for preserving donated lungs that do not initially meet the standard criteria for lung transplantation but 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.
The XPS can be used to warm the donor lungs to near body temperature and flush out waste products with the STEEN solution if more time is needed to determine if the donated lung is viable for transplantation. The XPS ventilates the lungs to aid the team in examining the lungs’ airways with a bronchoscope. The system can preserve donor lungs for up to 4 hours.
The XPS was designated as a Humanitarian Use Device (HUD) and was reviewed through the Humanitarian Device Exemption (HDE) pathway. Two clinical trials compared outcomes of lung transplant patients who received non-ideal donor lungs preserved using ex vivo lung perfusion with STEEN Solution to lung transplant patients who received ideal donor lungs from conventional storage techniques. Study results showed that recipients of the ideal and non-idela lungs had comparable survival rates up to 12 months post-transplant and similar rates of organ rejection.
For more information visit FDA.gov.