Donated or donor lungs can now be preserved, following the approval of XVIVO Perfusion System (XPS) with STEEN Solution by the U.S. Food and Drug Administration on Aug. 12.
XPS is a device that preserves donor lungs that initially don’t meet standard benchmarks for transplantation but may have the possibility for it, in cases of when there’s much time for observation and evaluation of the organ, to decide if the donated lung is doable for transplantation.
“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,” Christy Foreman, director of the Office of Device Evaluation at the Center for Devices and Radiological Health of the FDA, said in a statement.
The XPS device received the Humanitarian Use Device or HUD designation that means the device diagnoses or treats a health condition or disease that affects fewer than 4,000 individuals per year in the U.S. The device also was reviewed via a Humanitarian Device Exemption (HDE) pathway.
To get such type of approval, the manufacturer must be able to demonstrate safety and probably benefits of the device, such as not exposing the patients to unreasonable or considerable risk of injury or illness and the benefits outweighing the possible risks.
Apart from that, the company must prove that there’s no legally marketed comparable device available for the diagnosis or treatment of the condition or disease.
According to the FDA, the primary option to treat patients with end-stage chronic lung diseases such as cystic fibrosis, idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease.
About one out of five lungs donated meets the standard yardsticks for donor lung and is then used for transplantation. In cases when further time is required to ensure that the donated lungs meet the standard requirements for transplantation, this is where the XPS comes in.
The XPS device warms the donated lung close to normal temperature of the body and cleanses continuously its tissue with STEEN Solution that preserves lungs and gets rid of waste products. It also freshens the lungs that oxygenate cells and make it possible for a transplant team to carefully study the airways of the lungs using a bronchoscope.
Donated or donor lungs can be preserved in the device for a maximum of four hours, which is the time for a transplant team to inspect the lungs given and assess their functions. If the lungs meet particular functionality standards and pass the examination of the transplant surgeon, these lungs are then transplanted into a patient.
The XVIVO Perfusion, Inc., based in Englewood, Colorado, manufactured the XVIVO Perfusion System with STEEN Solution.
