Lung transplantation remains the only known life-saving treatment for end-stage lung disease as many patients die while waiting for suitable lungs to become available for transplant. On average, only 15 percent of lungs obtained from deceased donors are suitable for transplantation.
To increase the viability to provide more lungs for transplant, FDA https://www.fda.gov has approved the device called “Xvico Perfusion System” with Steen Solution Perfusate. The device is able to temporarily ventilate, oxygenate, and pump preservation solution through the lungs when the lungs are thought to be acceptable for transplant.
The device enables the transplant team to perform a more careful assessment of lung function to get a better sense of how the organs are working when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant. The most common adverse events associated with the device includes acute rejection, bronchial complications, respiratory failure, and infections.
FDA granted the premarket approval which is the most stringent type of device marketing application required by FDA to Xvico Perfusion Inc. https://www.xcicoperfusion.com, a company with headquarters in Sweden. FDA determined that the premarket application contained sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use.