FDA-approved device could give late-stage lung disease patients a greater chance of getting transplants

The Xvivo Perfusion System with Steen Solution Perfusate has been given premarket approval by the Food and Drug Administration, giving transplant teams a tool to assess lung function and transplant viability on organs that would otherwise be considered unusable. The device, manufactured by Xvivo Perfusion Inc., is used to temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through the lungs to determine their functionality.

Only about 15 percent of donated lungs are acceptable for transplantation, says the FDA, because often their viability is questionable due to poor lung quality, injury, etc. or because doctors have little time to find a suitable match. For end-stage lung disease, transplant is the only solution and many people who need them die waiting for a new lung. This new device aims to change that.  

The Xvivo Perfusion System works by allowing marginal quality lungs that initially failed to meet standard transplant criteria to undergo assessment in a standard normal body temperature for up to five hours, FDA explained. This provides an opportunity for surgeons to reassess transplant suitability, allowing them to transplant a certain percentage of lungs that were initially deemed to be unsuitable. The device consists of a perfusion cart with mechanical and electrical components that ventilate, oxygenate and perfuse the lungs with a lung preservation solution.

The FDA said it evaluated study results involving 332 sets of donor lungs separated into three groups:

· The control group consisted of lungs initially deemed suitable for transplant and provided to 116 recipients after standard preservation

· The second group of lungs were initially deemed unsuitable for transplant and, after being perfused with the Xvivo Perfusion System, were implanted into 110 recipients

· The third group were perfused with the Xvivo Perfusion System and were still deemed not suitable after the perfusion, and therefore were not implanted into patients.

The one-year survival rate was 94 percent for the control group compared to 86.4 percent for the lung perfusion patients but difference in rates were not considered clinically significant.

FDA says the technology had already received authorization in 2014 under a humanitarian device exemption but it could only be used on a maximum of 8,000 patients annually. This latest approval, FDA’s more stringent premarket approval pathway, has no patient limit which the agency said should help give patients who need a lung transplant a greater chance of receiving one.