NOVEL study

The NOVEL Lung Trial

The NOVEL Lung trial, sponsored by XVIVO Perfusion, is the first prospective and 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 that have been unused or rejected for transplantation.

The study started in 2011 and initially involved 6 centers in US. The study was extended to 17 centers participating. All participating centers used the XPS™ with STEEN Solution™, a fully integrated and flexible system that includes all components needed to safely run normothermic EVLP.

XPS™ – First FDA approved system for EVLP

In August 2014 the FDA approved use of the XPS™ integrated circuit with STEEN Solution™ for warm EVLP of initially unacceptable donated lungs. XPS™ with STEEN Solution™ is the first FDA approved system for EVLP of marginal lungs*.

Good interim results

Clinical outcome data from the first year of the NOVEL trial confirmed that EVLP with XPS™ and STEEN Solution™ is a safe diagnostic tool to increase the percentage of transplanted lungs by screening the unused donor pool. The trial was completed in July 2017 in the USA with the goal of 110 patients in each arm.

*Humanitarian Device. Authorized by Federal law for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation. The effectiveness of this device for this use has not been demonstrated.

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More than 70% of lungs donated worldwide are deemed unusable and not used for transplantation. Ex Vivo Lung Perfusion (EVLP) has been developed to expand the donor pool for lung transplantation.

What is Ex Vivo Lung Perfusion (EVLP)?

Ex Vivo Lung Perfusion (EVLP) is a process of evaluating and preparing donor lungs outside of the body prior to transplantation. EVLP with the XVIVO Perfusion System (XPS™) represents the next frontier in transplant medicine.

EVLP with XPS™ and STEEN Solution™ is a valuable and FDA approved resource to assess organs and potentially improve some that would have been turned down because of suboptimal quality.

How does it work?

EVLP with XPS™ and STEEN Solution™ is a method to assess viability of donated lungs. EVLP aims to expand the potential donor pool, by providing a near physiologic environment ultimately leading to decreased inflammation and rejection.

The EVLP technique is now routinely used clinically in Europe and North America. More than 300 lungs previously thought to be unusable have already been successfully transplanted using the method.

The process involves a 4-6 hours period during which the donated lungs are placed inside a sterile XVIVO Organ Chamber™ attached to a ventilator, pump and filters. The lungs are maintained at normal body temperature and perfused with STEEN Solution™, which is a colloid solution that contains nutrients, proteins and electrolytes, with or without red blood cells, depending upon choice of protocol. The warming and reperfusion period allows time for the lung to re-establish a near physiologic environment whilst the unique composition of the perfusate facilitates maintenance of homeostasis and removal of excess water in the lung. During the process, key indicators of lung function are evaluated continuously, e.g. gaseous exchange, airway pressure and lung compliance. When they are determined to be suitable, the lungs are transplanted into a waiting patient.

Advantages of EVLP include

  • Lungs are ventilated during the warm EVLP process to assess efficacy of physiologic gaseous exchange under near physiologic conditions
  • More time for preparation (to plan optimal timing of transplant surgery)
  • More time to make sure the lungs meet acceptability criteria
  • Increase the utilization of marginal/rejected donor lungs thereby expanding the donor pool