Prior to harvest and transplantation, donor lungs have to be verified for viability. And those that can’t be confirmed initially are often scrapped for fear of not being suitable for recipients. Yet, many of these discarded lungs are perfectly fine, simply requiring a longer term evaluation in preparation for transplantation. The XPS system from XVIVO Perfusion (Göteborg, Sweden) has just received regulatory approval from the FDA for preserving donor lungs that are otherwise challenging initially to confirm.
Donor lungs are placed inside the machine that maintains a proper temperature while perfusing the lungs with a sterile liquid called STEEN Solution and oxygenating them to allow examination with a bronchoscope. The system gives clinicians up to four hours of evaluation of the donated organs, hopefully making a lot more donor lungs available for successful transplantation.
From an FDA announcement of the approval:
The FDA’s review of the XPS included two clinical trials supporting the safety and probable benefit of the device. Both trials compared outcomes of lung transplant patients who received non-ideal donor lungs preserved using ex vivo lung perfusion with STEEN Solution to lung transplant patients who received ideal donor lungs that were preserved using conventional cold storage techniques. Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection. As a condition of approval, the manufacturer will conduct a post-approval study of the long-term effects of the device and adverse events.
Here’s Dr. Shav Keshavjee showing off pig lungs being kept alive in the EVLP at TEDMED 2010:
Product page: Ex Vivo Lung Perfusion (EVLP)…