The Xvivo Perfusion System looks like a medical device out of a science fiction movie, but it’s real and it was just granted FDA approval. The technology opens the door to a greater number of lung transplants by enabling teams to evaluate and potentially approve donor organs that would otherwise be discarded. The system was previously approved under a humanitarian device exemption, but that limited the number of patients who could benefit from the technology.
Lung transplants save lives, but the number of people in need of a transplanted organs greatly exceeds the number of viable donor organs available. This is due, in part, to the suitably of the donor lungs for transplant; according to the FDA, only 15-percent of donated lungs are actually considered suitable for transplant into patients.
This low number is due to ‘questionable’ physiological function — if a lung has possibly been injured, for example, it won’t be transplanted. So the same goes for lungs that are potentially of low quality. Increasing the number of viable lung transplants is necessary for saving lives, and that’s where the Xvivo Perfusion System comes in.