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XVIVO
  • Contact us
  • Customer support
  • Home
  • Technology
    • Introduction to Ex Vivo Lung Perfusion
    • The Ex Vivo Lung Perfusion Process
    • Clinical
    • Protocols
    • Starting your clinical EVLP program
    • Articles about EVLP
    • EVLP with Manual method
    • EVLP with XPS™
    • Training and workshops
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    • XPS Disposable Lung Kit™
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      Organ Chamber™
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      Lung Cannula Set™
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Progress made in the NOVEL study in the USA

Indiana University Health in Indianapolis, USA has performed its first transplantation using lungs from a DCD (Donation after Circulatory Death) donor within the framework of the NOVEL-study. This has been made possible by using STEEN Solution™ and the XPS™ to evaluate the lung function outside the body. The FDA advisory committee meeting will be held on March 20, 2014.

The number of lungs from DCD donors used in lung transplantation is limited today, but using the STEEN Solution™ method, these lungs can also be used for transplantation to a greater extent than would otherwise be possible. It is XVIVO Perfusion’s assessment that the number of lung transplants can be many times greater in the future when the use of lungs from DCD donors is more extensively employed.

Dr Thomas Wozniak, Lung Transplant Surgical Director at IU Health stated recently that "Despite the fact that most DCD lungs satisfy standard criteria for transplantation, changes can occur during the DCD process that can render some of these organs suboptimal. Prior to the availability of XVIVO, there was no way to determine which of these lungs would fail other than implanting them into recipients. For this reason, we have not previously utilized DCD lungs. With XVIVO perfusion, we are now more able to predict which of these lungs will be suitable for implantation into a recipient. To date, our program has transplanted 2 patients utilizing XVIVO technology that otherwise would not have been considered for DCD lungs."

The FDA process is proceeding according to plan and XVIVO Perfusion has submitted material for the advisory committee meeting to be held on March 20, 2014. The expert panel consists of external experts and it primarily assesses the results from the NOVEL study in the USA. The expert panel gives advice and recommendation to the FDA regarding regulatory questions.

"It is good news that IU Health has performed its first transplantation of lungs from a DCD donor using STEEN Solution™ and the XPS™. As the donor pool can become many times greater if there is access to DCD donors’ lungs and the STEEN Solution™ EVLP method enables more patients with severe lung disease improved access to lung transplantation and therefore to enjoy a longer and better life." says Dr Magnus Nilsson, CEO of XVIVO Perfusion.

March 14, 2014
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO

For further information please contact:


Christoffer Rosenblad, CFO, 46 31 788 21 59, christoffer.rosenblad@xvivoperfusion.com

For further information on XVIVO Perfusion’s business, please refer to the company’s website, www.xvivoperfusion.com

XVIVO Perfusion is required to publish the information in this press release in accordance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. The information was submitted for publication on March 14, 2014 at 8:30 a.m.

This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.

About us

Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs so transplant teams around the world can save more lives.
Our solutions allow leading clinicians and researchers to push the boundaries of transplantation medicine.
XVIVO is headquartered in Gothenburg, Sweden, and has offices and research sites on three continents. The company is listed on Nasdaq.

Contact

Swedish Office
XVIVO Perfusion AB
Box 53015
SE-400 14 Göteborg
Sweden

Phone: +46 31 788 21 50
Fax: +46 31 788 21 69
info@xvivogroup.com

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