Supporting clinical data
After extensive experimental research, the use of EVLP has been successfully introduced into clinical practice. The first lung to be successfully transplanted after EVLP was in Sweden in 2001 and the protocol was later modified for long-term assessment by the group in Toronto.
Centers worldwide have implemented EVLP in their clinical programs following the Toronto protocol either using the XPS™ or a manual approach. Published reports from several centers show favorable clinical outcomes and clinical trials confirm these results.
Landmark studies confirm long-term safety of EVLP
The HELP Study
Reviewing the results of 50 consecutive lung transplantations performed after warm EVLP by the Toronto group in 2012, the authors concluded that 4-hour normothermic acellular EVLP is safe and provides similar outcomes compared with conventionally selected and transplanted donor lungs.
Good interim results presented – The NOVEL Study
The NOVEL study was the first prospective, multicenter clinical trial designed to evaluate the safety of Ex Vivo Lung Perfusion (EVLP) as a method to screen and identify good quality grafts from lungs previously rejected for transplantation.
The one-year follow up of the study showed that EVLP using the integrated XPS™ circuit with STEEN Solution™ as perfusate is a safe diagnostic tool to increase the percentage of transplanted lungs by screening the unused donor pool.