XVIVO Perfusion System for Donor Lung Preservation and Assessment Finally Approved by FDA

XVIVO Perfusion, a company based out in Göteborg, Sweden, has been approved to introduce its Xvivo Perfusion System in the United States to effectively renew lungs that would otherwise would not be good enough for transplantation. The system ventilates, oxygenates, and pumps the Steen Solution Perfusate, a buffered extracellular solution, through the donor lungs while they’re inside the device. It essentially keeps the lungs alive and breathing independent of a human body. Since organs are typically cooled, packed, and rapidly shipped after harvesting, they’re not really kept alive and end up degrading quickly.

The XVIVO Perfusion System, because it can feed and keep alive donor lungs, can therefore greatly expand the potential donor pool of organs that would be viable at the time of implantation. As far as the FDA’s approved indication, it is to be used to perfuse, ventilate, and oxygenate imperfect lungs that initially failed certain quality criteria. After up to five hours of such treatment, the lungs are to be re-evaluated and at that point they may end up ready for implantation.

Moreover, in the future the system may give clinicians extra information to make optimal plans for implantation and even maybe calm clinicians that are normally trying to really speed the process along. Additionally, the time to delivery can now also potentially be expanded and therefore organs may be delivered to more distant places safely.

Here’s a video of Dr. Shaf Keshavjee at TEDMED 2010 showing off an earlier version of the system and explaining the motivation for it and how it works:

 

Product page: XVIVO Perfusion System…

Via: FDA