Clinical

Supporting clinical data

After extensive experimental research, the use of EVLP (Ex Vivo Lung Perfusion) has been successfully introduced into clinical practice. The first lung to be successfully transplanted after EVLP was in Lund, Sweden in 2001 and the protocol was later modified for long-term assessment by the group in Toronto, Canada.

Centers worldwide have implemented EVLP in their clinical programs following the Toronto protocol either using the XPS™ or a manual approach. Published reports from a number of individual centers show favorable clinical outcomes and clinical trials confirm these results.

Landmark studies confirm long-term safety of EVLP

The HELP Study

The HELP study, completed 2010 in Toronto, published the results of their ongoing use of EVLP at their site in 2012(JCTVS. 2012 Nov;144(5):1200-6). Reviewing the results of 50 consecutive lung transplantations performed after warm EVLP by the Toronto group, 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 EVLP as a method to evaluate 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 screen the unused donor pool in order to increase the percentage of lungs transplanted.

  • EVLP with XPS™

    • XPS Disposable Lung Kit™ including all components needed for one EVLP procedure • Gas mix

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  • EVLP with XVIVO LS™

    • XVIVO LS Disposable Lung Set™ including all components needed for one EVLP procedure • Gas mix • STEEN Solution™

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  • EVLP with manual method

    • Hardware/Software • STEEN Solution™ • Disposables • Tubing • Gas mix

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