The US Food and Drug Administration (FDA) has approved a device that will allow more lungs to be available for transplant. The Xvivo Perfusion System with Steen Solution Perfusate can temporarily ventilate, oxygenate, and pump preservation solution through lungs previously deemed unacceptable for transplant.
The device was originally given marketing authorization in 2014 under a “humanitarian device exemption,” but this regulatory pathway limited the device’s use to a maximum of 8000 patients per year. Now through FDA’s premarket approval process, the Xvivo Perfusion System will no longer have these restrictions, which will increase the number of lungs available and therefore, the number of patients who will benefit.
Lungs that initially failed to meet the standard transplant criteria can be ventilated, oxygenated, and perfused at a standard normal body temperature for up to 5 hours using the Xvivo Perfusion System. The transplant team can then perform a more careful assessment of lung function to determine how the organs work when they are perfused with a solution outside of the body.
The FDA based part of the approval on a study that assessed patient survival in lung transplantation. A total of 332 donor lungs were assigned to 1 of 3 groups: the control group (suitable lungs transplanted to 116 recipients after standard preservation); lungs initially determined to be unsuitable which were then perfused with the Xvivo Perfusion System and transplanted to 110 recipients; and lungs that were perfused with Xvivo Perfusion System but still unsuitable for transplant. The control group had a 1-year-survival rate of 94% compared with 86.4% in the lung perfusion group. This difference was not considered clinically significant. Acute rejection, bronchial complications, and respiratory failure and infections were the most common adverse events reported.
“Sadly, too many patients on transplant lists die waiting for suitable lungs,” said Benjamin Fisher, PhD, director of the Division of Reproductive, Gastro-renal, Urological Devices at the FDA’s Center for Devices and Radiological health. “[W]e support the development of innovative technologies that can increase the organ donor pool for transplant patients in need of suitable lungs.”
FDA approves device to help increase access to more lungs for transplant [news release]. Silver Spring, MD: US Food and Drug Administration; April 26, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-device-help-increase-access-more-lungs-transplant. Accessed May 8, 2019.