Federal regulators at the FDA have approved the XVIVO Perfusion System (XPS) with STEEN Solution to preserve “high-risk” donated lungs that “initially do not meet the standard criteria" for such an operation but may be transplantable if there is more time to observe and evaluate the organ’s function to determine whether it can be used after all.
According to the agency, only 1 in 5 donated lungs are found to be suitable as replacement organs. In some cases, however, XPS can be used to warm the donor lungs to near normal body temperature and continuously flush the lung tissue with sterile STEEN Solution via pumps and filters connected to a bubble-like chamber, which preserves the lungs and removes waste products until that determination can be acertained. 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 for up to 4 hours.
It is now hoped that by giving them more time to consider lungs that may be questionable, surgeons may be able to save more critically ill patients than previously possible. For instance, although 1,754 patients received transplanted lungs in 2012, another 1,616 were left on waiting lists.
Lung transplantation is a primary option in the care of patients with end-stage chronic lung diseases, such as chronic obstructive pulmonary disease, cystic fibrosis and idiopathic pulmonary fibrosis.
“This innovative device addresses a critical public health need,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “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.”
Note: The FDA’s review of the XPS included two clinical trials supporting the safety and probable benefit of the device. Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection. As a result, the Food and Drug Administration has designated the XPS as a Humanitarian Use Device (HUD) designation used to treat or diagnose conditions or diseases that affect less than 4,000 people in the US each year.