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.
The FDA explains that the newly approved technology is able to ventilate, oxygenate, and pump donor lungs that are of ‘marginal quality,’ namely ones that failed to meet the criteria needed for transplant suitability. The lungs can be pumped for up to five hours while kept at a normal body temperature, giving doctors the opportunity to determine whether the lungs are actually suitable for transplant into a patient.
Some lungs that would otherwise be discarded because of the potential for issues may then be evaluated as suitable, increasing the number of available donor lungs. However, under the humanitarian device exemption that was granted in 2014, the system was limited to use with up to 8,000 patients annually.
As of today, the FDA has granted Xvivo Perfusion Inc premarket approval, which is ‘the most stringent type of device marketing application required’ by the agency, it said in its announcement. This approval does not limit the number of patients who can benefit from the technology.