The US FDA has approved the Xvivo Perfusion System, 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.
