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FDA Approves Donor-Lung Preservation Device
The FDA has approved the XVIVO Perfusion System (XPS) with STEEN Solution (XVIVO Perfusion, Inc.), a device 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.
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. Approximately one in five 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 U.S., and at the end of that year, 1,616 potential recipients remained on the waiting list.
According to the FDA, if additional time is needed to determine whether 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 to 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 4 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’s examination, they are transplanted into a recipient.
The FDA’s review of the XPS included two clinical trials that supported the safety and probable benefit of the device. Both studies compared the outcomes of lung-transplant patients who received non-ideal donor lungs preserved using ex vivo lung perfusion with STEEN Solution with the outcomes of transplant patients who received ideal donor lungs that were preserved using conventional cold storage techniques.
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 condition of the FDA’s approval, the manufacturer will conduct a post-marketing study of the long-term effects of the device and associated adverse events.
Source: FDA; August 12, 2014.