MONDAY, April 29, 2019 — The Xvivo Perfusion System has been approved by the U.S. Food and Drug Administration to help doctors determine whether lungs are suitable for transplant, the agency said in a news release.
The device can temporarily ventilate, oxygenate and pump preservation solution through the lungs, allowing a transplant team to conduct a more thorough assessment of lung function.
The device was given limited approval in 2014, curtailing its use to a maximum of 8,000 patients per year, the agency said. The new approval removes that and other restrictions.
Lung transplant remains the only approved treatment for advanced lung disease, and many people die while waiting for donor lungs to become available. On average, 15 percent of donor lungs are suitable for transplant, the FDA said. About 2,530 lung transplants were performed last year, U.S. government statistics show.
The device’s most common adverse reactions included bronchial complications, respiratory failure and infections.
The product is produced by the Swedish company Xvivo Perfusion Inc.