XPS™

XPS™

The flexible comprehensive EVLP platform

The XVIVO Perfusion System (XPS™) is part of our ambition to provide our customers with solutions and systems that can improve the transplant process outcome, facilitate the work of the transplant team and enhance the long-term outcomes and quality of life for the transplant recipient.

Increase your lung donor pool with a fully flexible and comprehensive platform for EVLP

  • Proven clinical protocol and extensive clinical practice
  • Developed with daily clinical challenges in mind
  • Based on expertise and experience from clinicians

First FDA approved device for EVLP

The XPS™ is CE-marked and FDA approved for ex vivo lung perfusion of initially unacceptable donated lungs*. The NOVEL Study in USA was designed to establish the safety of the method.

The NOVEL Study – Establishing the safety of the method

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 that have been unused or rejected for transplantation.

The one-year follow up of the study showed that EVLP with XPS™ and STEEN Solution™ is a safe tool to increase the percentage of transplanted lungs by screening the unused donor pool.

The NOVEL study – movie

XPS™ – the first FDA approved and clinically proven EVLP technology on the market

  • Gives you total control of the entire EVLP process
  • Supported by clinical experience and knowledge
  • All required EVLP components integrated
  • X-ray possibilities
  • In-line gas monitoring
  • Continuous data recording – evaluate for safety and control

Integrated system for innovative technique

  • CardioHelp XVIVO Centrifugal Pump
    – Quadrox-iR next-generation oxygenator
  • Separate sterile area and perfusionist non-sterile area
  • Heater/Cooler (15-39°C)
  • Hamilton C2 ICU Ventilator
  • In-line gases (pO2, pH)
  • Touchscreen user interface
  • Extract and analyse data
  • Configured to allow X-ray of lungs

Operational benefits on-site

  • Flexible and comprehensive platform for normothermic EVLP
  • User remains in control as the EVLP process is performed on-site
  • Continuous data recording – evaluate for safety and control
  • User-friendly system
  • Supported by clinical experience and knowledge
  • X-ray possibilities

Flexibility

  • Adjustable to preferred clinical protocol
  • Adjustable flow to preferred clinical protocol
  • Adjustable ventilation

All required EVLP components integrated

XPS™ is a fully integrated off-the-shelf cardiac bypass system that includes all components needed to safely run normothermic EVLP. The XPS™ system is based on innovative technology from leading companies and includes a centrifugal pump (MAQUET CardioHelp), heater/cooler and ICU-ventilator (Hamilton C2).

The XPS™ is intended to be used with STEEN Solution™ for flushing and temporary continuous normothermic perfusion of initially unacceptable excised donor lungs, during which time the function of the lungs can be evaluated and assessed as viable transplantable organ.**

** as per FDA approval August 2014.

The XVIVO Perfusion System (XPS™) is intended for flushing and temporary continuous normothermic machine perfusion of isolated lungs, during which time the function of the lungs can be assessed for transplantation. (for all other countries)

Developed with daily clinical challenges in mind

The system was developed together with clinicians with genuine experience and knowledge from normothermic EVLP using STEEN Solution™. Understanding the clinical needs and challenges transplant teams encounter in daily work, XPS™ facilitates the clinical decision making and offers a flexible comprehensive platform for EVLP.

Allowing for standardization of EVLP

XPS™ was developed to provide transplantation teams with a consistent and easy-to-use method of performing EVLP in the hospital. The objective was to develop an automated perfusion system that would allow for standardization of EVLP, without interfering with the need for clinical flexibility.

The donor lungs are transported in regular manner, in a cooler box from the procurement site. The donor lungs are flushed thoroughly with Perfadex® and then put on the EVLP platform. After warming up according to a detailed protocol, it is up to the EVLP team to set preferred ventilation and perfusion strategies depending on the requirements of each donor lung. Integrated in-line perfusate gas monitors (PGM) enables for real-time trending of pH and pO2 during the entire EVLP procedure. The XPS™ also enables precise continuous monitoring of EVLP performance metrics, all pre-set by the EVLP team.

xray

X-ray possibilities

XPS™ is specifically designed for allowing X-ray while performing normothermic EVLP. If a mobile unit is not available, XPS™ may be transported within the hospital as it is built with a long life battery. This allows for simultaneous X-ray without interrupting the EVLP process.

Continuous data recording – evaluate for safety and control

The touch-display monitors and software allows monitoring the procedure and components as well as data capturing. The software captures and displays key performance data in real time. Parameters displayed are PVR, delta pO2 etc. Data can easily be downloaded via an USB port.

display_2

In-line Perfusate Gas Monitors (PGM) for real-time trending

The XPS™ is equipped with two in-line gas monitors, which enables real-time trending of pH and pO2 during EVLP.

 

Supporting data – Clinically proven

The use of EVLP has after extensive experimental research been successfully transformed into clinical practice. Published reports from several centers show favorable clinical outcomes and clinical trials confirm these results.

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 that have been unused or rejected for transplantation. The participating centers in the NOVEL study used PERFADEX®, STEEN Solution™ and the XPS™ system to evaluate and assess rejected donor lungs.

The one-year follow up of the study showed 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.

Read more

Order: REF 19040 XPS™; 1 unit REF 19030 XPS™ (for US market only); 1 unit
Content: 1 unit. The XPS™ is a fully integrated off-the-shelf cardiac bypass system that includes components needed to safely run normothermic EVLP. The XPS™ system includes a centrifugal pump (MAQUET CardioHelp), heater/cooler and ICU-ventilator (Hamilton C2).
Storage: Store at room temperature
Intended use: The XPS™ is intended to be used with STEEN Solution™ for flushing and temporary continuous normothermic perfusion of initially unacceptable excised donor lungs, during which time the function of the lungs can be evaluated and assessed as viable transplantable organ.**

** as per FDA approval August 2014.

The XVIVO Perfusion System (XPS™) is intended for flushing and temporary continuous normothermic machine perfusion of isolated lungs, during which time the function of the lungs can be assessed for transplantation. (For all other countries)

 

The system received the CE mark in March 2014 together with the accompanying disposable products. In August 2014 the FDA approval was obtained and the system is now available for all customers in the US.

 XPS™ has been developed in contact with Toronto General Hospital and according to their successful clinical development of EVLP. All of the participating centers in the ongoing NOVEL trial in the US are using the XPS™ system. The XPS™ will make the EVLP procedure easier to perform, demand less time to set up and use fewer personnel than would a manually performed EVLP.

*Humanitarian Device. Authorized by Federal law in the USA 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.