FDA OKs Technology That Preserves Lungs for Transport and Transplant

The U.S. Food and Drug Administration (FDA) approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device made by XVIVO Perfusion Inc. 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 products have already received a CE mark and are approved for sale in the European market.

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, according to figures cited by the FDA. In 2012, 1,754 lung transplants were performed in the United States and at the end of that year, 1,616 potential recipients remained on the waiting list. A little more than 40 percent of all lung transplantations worldwide are carried out in the United States, according to XVIVO officials.

“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.”

If additional time is needed to determine if 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 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 four 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 examination, they are transplanted into a recipient.

The XPS received a humanitarian use device (HUD) designation and was reviewed through the humanitarian device exemption (HDE) pathway. A HUD is a device that treats or diagnoses a disease or condition affecting fewer than 4,000 individuals in the United States per year.

In order to receive this type of approval, a company must demonstrate, among other things, safety and probable benefit—i.e., that the device will not expose patients to an unreasonable or significant risk of illness or injury, and that the probable benefit of the device outweighs the risk of illness or injury. In addition there can be no legally marketed comparable devices, other than another HDE, available to treat or diagnose the disease or condition.

The FDA’s review of the XPS included two clinical trials supporting the safety and probable benefit of the device. Both 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 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 approval, the manufacturer will conduct a post-approval study of the long-term effects of the device and adverse events.

“It is a breakthrough for XVIVO that we have now received approval from the FDA and can initiate sales of STEEN Solution and XPS in the American market after a time-consuming and comprehensive process with high patient and product safety requirements,” said says Dr. Magnus Nilsson, CEO of XVIVO Perfusion AB. “The XPS machine and STEEN Solution mean that XVIVO now has a clinically proven method that is both CE marked and approved by the FDA. This method allows more lungs to be used for transplantation, which will potentially enable more patients with severe lung disease to achieve a greater quality of life as well as a longer life.”

XVIVO Perfusion’s U.S. base is in Englewood, Colo. The company is headquartered in Gothenburg, Sweden.