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 2000 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, or the Scandinavian protocol using the XVIVO LS™ . 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.

The NOVEL/ NOVEL Extension Trial

In August 2014, the FDA granted Humanitarian Device Exemption (HDE) approved use of the XPS™ with STEEN Solution™ for normothermic EVLP of initially unacceptable donated lungs. XPS™ with STEEN Solution™ is the first FDA approved system for EVLP of marginal lungs. In April 2019, the FDA granted Pre-Market Approval (PMA) for use of the XPS™ with STEEN Solution™ for normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex vivo function of the lungs can be reassessed for transplantation. A PMA is the most stringent FDA approval process for medical devices in the United States, with requirements for both safety and efficacy to be met.

To read more about the Novel/Novel Extension Trial, press here.

  • 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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