XVIVO has received market approval from the FDA for STEEN Solution™ and XPS™.
ET | Source:Xvivo Perfusion AB
On August 12, 2014 at 6:03 p.m. CET XVIVO received HDE (Humanitarian Device
Exemption) approval from the FDA for the products XPS™ and STEEN Solution™ for
sale on the American market. The approval, which is the first in the USA for
warm perfusion of organs outside the body pending transplantation, means that
STEEN Solution™, XPS™ and the accompanying single-use articles are the only
medical device products that may be legally sold for Ex Vivo Lung Perfusion
(EVLP) of initially unacceptable donated lungs at body temperature. Just over
40 percent of all lung transplantations worldwide are carried out in the USA.
The products have already received a CE mark and are approved for sale in the
After several years of product development in close collaboration with
experienced transplantation centers, and subsequent comprehensive clinical
studies in Canada and the USA to verify both product and patient safety, XPS™
and STEEN Solution™ have received FDA approval as a Humanitarian Use Device
(HUD). The work on obtaining market approval from the FDA was started in 2009
and an HDE application was submitted in July 2012. During the process, clinical
studies have been carried out to demonstrate product and patient safety, and in
March 2014 the FDA’s Advisory Panel voted unanimously that XPS™ and STEEN
Solution™ meet the requirements for HDE approval. After yesterday’s approval,
the products may now be sold in the American market, and together will be
labeled for the warm perfusion of initially unacceptable donated lungs.
EVLP with STEEN Solution™ has been used in more than 300 lung transplantations
at almost 30 clinics, in Vienna, Paris, Toronto and elsewhere, and has displayed
stable results there, similar to those that XVIVO Perfusion published from the
American NOVEL study (see press release dated March 21, 2014).
“It is a breakthrough for XVIVO that we have now received approval from the FDA
and can initiate sales of STEEN Solution™ and XPS™ in the American market after
a time-consuming and comprehensive process with high patient and product safety
requirements. The XPS™ machine and STEEN Solution™ mean that XVIVO now has a
clinically proven method that is both CE marked and approved by the FDA. This
method allows more lungs to be used for transplantation, which will potentially
enable more patients with severe lung disease to achieve a greater quality of
life as well as a longer life,” says Dr. Magnus Nilsson, CEO of XVIVO Perfusion
August 13, 2014
XVIVO Perfusion AB (publ)
For further information please contact:
Christoffer Rosenblad, CFO, +46 31 788 21 59,
For further information on XVIVO Perfusion’s business, please refer to the
company’s website, www.xvivoperfusion.com
The information was submitted for publication on August 13, 2014 at 8:30 a.m.
XVIVO Perfusion AB is a medical technology company which develops solutions and
systems for assessing and preserving organs outside the body and for selecting
usable organs and maintaining them in optimal condition pending transplantation.
The company is headquartered in Gothenburg, Sweden, and has one office in the
USA. The XVIVO share is listed on NASDAQ OMX First North and has the ticker
symbol XVIVO. More information can be found on the website
www.xvivoperfusion.com. The Certified Adviser is Redeye, www.redeye.se.
XVIVO Perfusion AB (publ), Box 53015, SE-400 14 Göteborg. Corporate identity
Tel: 46 31 788 21 50. Fax: 46 31 788 21 69.
E-mail: firstname.lastname@example.org. Website: www.xvivoperfusion.com
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