Lung Preservation Device Could Increase Donor Pool

The system works by mimicking in vivo conditions, flushing and temporarily preserving continuous normothermic perfusion of initially unacceptable excised donor lungs for up to four hours. During this time, the function of the lungs can be reevaluated and assessed for viability as a transplantable organ. If they meet functionality criteria, and pass the transplant surgeon examination, the lungs are transplanted into a recipient.

The ventilated lung is perfused with a 15% deoxygenated suspension of red blood cells (RBCs) in STEEN Solution while critical parameters of gaseous exchange, pulmonary vascular resistance, and other key variables under normothermic conditions are monitored. The XPS also ventilates the lungs, which oxygenates the cells and makes it possible for the transplant team to examine the airways with a bronchoscope. The XVIVO Perfusion System is a product of XVIVO Perfusion (Englewood, CO, USA), and has been approved by the US Food and Drug Administration (FDA).

“This innovative device addresses a critical public health need,” said Christy Foreman, director of the office of device evaluation at the FDA Center for Devices and Radiological Health (CDRH). “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.”

Lung transplantation is a primary option in the care of patients with end-stage chronic lung diseases, such as chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), 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 United States alone; at the same time, 1,616 potential recipients remained on the waiting list.

STEEN Solution contains human serum albumin to provide normal oncotic pressure, preventing edema formation; dextran, a mild scavenger which coats and protects endothelium from subsequent excessive leucocyte interaction and thrombogenesis; and an extra-cellular electrolyte composition (lowK +) that reduces free radical generation and avoids vascular spasm under normothermic conditions.

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