FDA Approval for Lung Preservation Device
- January 31, 2018
The U.S. Food and Drug Administration (FDA) has announced its approval of a unique device that can make more lung transplants possible. Designed by a Swedish company, the XVivo Perfusion System (XPS) with Steen Solution is used with donor lungs that upon initial assessment do not meet the criteria for transplantation, but with further evaluation may actually be deemed viable.
The XPS device provides a stable environment where those lungs can be kept for up to four hours, or at least until they are examined. To preserve the lungs, it warms them up so they stay at near body temperature. To remove waste products, the lung tissue is flushed continually with a sterile Steen solution.
The availability of this system could help solve the supply gap in lung transplants, a critical public health problem. According to the FDA, only one in five donor lungs are used in transplants. In 2012, for instance, lung transplants in the United States numbered 1,754. But there were still 1,616 candidates on the waiting list as the year closed.
“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,” said Christy Foreman of the FDA’s Center for Devices and Radiological Health.
Vivo Perfusion AB, the company behind the XPS device, is looking forward to helping increase the number of lung transplants performed. CEO Dr. Magnus Nilsson said, “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.”
The FDA requires the company to carry out post-marketing studies to determine if the system has any long-term effects and negative outcomes.
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