{"id":3166,"date":"2014-08-13T06:30:00","date_gmt":"2014-08-13T06:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/xvivo-has-received-market-approval-from-the-fda-for-steen-solution-and-xps\/"},"modified":"2014-08-13T06:30:00","modified_gmt":"2014-08-13T06:30:00","slug":"xvivo-has-received-market-approval-from-the-fda-for-steen-solution-and-xps","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/xvivo-has-received-market-approval-from-the-fda-for-steen-solution-and-xps\/","title":{"rendered":"XVIVO has received market approval from the FDA for STEEN Solution\u2122 and XPS\u2122."},"content":{"rendered":"
On August 12, 2014 at 6:03 p.m. CET XVIVO received HDE (Humanitarian Device Exemption) approval from the FDA for the products XPS\u2122 and STEEN Solution\u2122 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\u2122, XPS\u2122 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.\u00a0 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 European market.<\/strong><\/div>\n

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\u2122 and STEEN Solution\u2122 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\u2019s Advisory Panel voted unanimously that XPS\u2122 and STEEN Solution\u2122 meet the requirements for HDE approval. After yesterday\u2019s 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. <\/span><\/p>\n

EVLP with STEEN Solution\u2122 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).<\/span><\/p>\n

\u201cIt is a breakthrough for XVIVO that we have now received approval from the FDA and can initiate sales of STEEN Solution\u2122 and XPS\u2122 in the American market after a time-consuming and comprehensive process with high patient and product safety requirements. The XPS\u2122 machine and STEEN Solution\u2122 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,\u201d says Dr. Magnus Nilsson, CEO of XVIVO Perfusion AB.<\/span><\/p>\n

August 13, 2014
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson
CEO<\/span><\/p>\n

\n

For further information please contact:
<\/span>
Christoffer Rosenblad, CFO, +46 31\u00a0788 21 59, christoffer.rosenblad@xvivoperfusion.com<\/a><\/span>
For further information on XVIVO Perfusion\u2019s business, please refer to the company\u2019s website, www.xvivoperfusion.com<\/a><\/span><\/p>\n

The information was submitted for publication on\u00a0August 13, 2014\u00a0at 8:30 a.m.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

On August 12, 2014 at 6:03 p.m. CET XVIVO received HDE (Humanitarian Device Exemption) approval from the FDA for the…<\/p>\n","protected":false},"template":"","class_list":["post-3166","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-lang-en","mfn-news-tag-mfn-regulatory","mfn-news-tag-mfn-regulatory-listing","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"\nXVIVO has received market approval from the FDA for STEEN Solution\u2122 and XPS\u2122. - XVIVO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.xvivogroup.com\/us\/pressreleases\/xvivo-has-received-market-approval-from-the-fda-for-steen-solution-and-xps\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"XVIVO has received market approval from the FDA for STEEN Solution\u2122 and XPS\u2122. - 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