{"id":3220,"date":"2013-07-09T06:30:00","date_gmt":"2013-07-09T06:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/all-patients-included-in-the-novel-trial-in-the-usa-with-steen-solution\/"},"modified":"2013-07-09T06:30:00","modified_gmt":"2013-07-09T06:30:00","slug":"all-patients-included-in-the-novel-trial-in-the-usa-with-steen-solution","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/all-patients-included-in-the-novel-trial-in-the-usa-with-steen-solution\/","title":{"rendered":"All patients included in the NOVEL trial in the USA with STEEN Solution\u2122"},"content":{"rendered":"
In June all the patients were included in the clinical study with STEEN Solution\u00d4 according to plan. Interim results confirms previous single center experience, that initially rejected lungs evaluated with Ex Vivo Lung Perfusion (EVLP) perform similarly to standard criteria lungs after transplantation and that the use of EVLP to screen the marginal donor pool is safe. The patients will be followed up for one year after transplantation.<\/strong><\/div>\n

The NOVEL trial is a multicenter study performed at 6 sites in USA and was designed to safely increase the percentage of usable lungs from the donor pool. In the study, clinical outcomes associated with ex-vivo lung perfusion (EVLP) of initially rejected or marginal lungs were compared with contemporary matched controls. A total of 42 patients received transplants using the STEEN Solution\u2122 method and was matched with 42 control patients. The initial results indicate that initially rejected lungs that were perfused with Steen Solution\u2122 perform as well as lungs that initially were deemed good for use. This is in line with experiences from centers in Europe and Canada where EVLP with STEEN Solution\u2122 is in clinical practice.<\/span><\/p>\n

At the International Society of Heart and Lung Transplantation (ISHLT) conference in Montr\u00e9al, the interim results were presented and confirmed previous single center experiences that initially rejected lungs evaluated with Ex Vivo Lung Perfusion (EVLP) perform similarly to standard criteria lungs after transplantation. The results also indicate that the use of EVLP to screen the marginal donor pool is safe. At the same conference, the combined outcome data from Toronto (Canada), Vienna (Austria) and Paris (France) were presented with 140 assessed and 114 transplanted lungs. More than 240 patients have now received lungs evaluated with STEEN Solution\u2122 method which would have otherwise remained unused without this technology. <\/span><\/p>\n

\u201cThe clinical results from the study are very encouraging and demonstrates that STEEN Solution\u2122 safely makes many more organs available for this life-saving treatment of patients with end-stage lung deceases\u201d says Dr Magnus Nilsson, CEO of XVIVO Perfusion. <\/span><\/p>\n

July 9, 2013<\/span><\/p>\n

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

\n

For further information please contact:
<\/span>
Christoffer Rosenblad, CFO, tel: 46 31\u00a0788 21 59, e-mail: 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

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\u00a0July 9, 2013\u00a0at 8:30 a.m.<\/span><\/p>\n

This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

In June all the patients were included in the clinical study with STEEN Solution\u00d4 according to plan. 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