The FDA today approved a device that could make more donated lungs available for transplant.
The XVIVO Perfusion System (XPS) with STEEN Solution provides doctors more time to observe and evaluate the function of a donated lung to determine whether it meets the criteria for transplant. Due to the fact that most donated lungs do not meet the initial criteria for transplantation, the XPS could make a major difference for patients suffering from 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, in a press release
. “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.”
The FDA said only 1 out of every 5 lungs that are donated meet the criteria to be transplanted into a patient. The agency further noted there were 1754 lung transplants performed in the United States in 2012, though 1616 potential recipients remained on the waiting list at the end of that year.
In instances where more time is necessary to evaluate whether a donated lung is suitable for a lung transplant, the XPS device can warm the donor lungs to near normal body temperature. The device also flushes lung tissue with the STEEN Solution, a sterile fluid that removes waste products and preserves the organ.
The XPS also provides ventilation for the lungs to oxygenate its cells and make it possible for doctors to examine the airways with a bronchoscope. Donor lungs are subsequently able to stay in the device for up to 4 hours, allowing for a thorough evaluation of organ function.
The XPS underwent 2 clinical trials that compared outcomes for lung transplant patients who received non-ideal donor lungs preserved using ex vivo lung perfusion with STEEN Solution with transplant patients who received ideal donor lungs preserved using conventional storage techniques. The researchers found similar rates of organ rejection and survival up to 12 months after transplant in both the ideal and non-deal groups.
The XPS was granted Humanitarian Use Device (HUD) designation and was approved by the FDA through the Humanitarian Device Exemption (HDE) pathway, which evaluates devices that treat or diagnose diseases and conditions affecting fewer than 4000 patients per year.
The conditional approval requires a follow-up study for the long-term effects and adverse events associated with the XPS.