Application for market approval of STEEN SolutionTM in the USA has been submitted to the FDA
Vitrolife has submitted an application to the American Food and Drug Administration (FDA) regarding market approval of STEEN SolutionTM, a product used for cleansing and evaluation of lungs outside the body (ex vivo) before transplantation.
The application was based on successful results from the clinical trial that Vitrolife is conducting in the USA with STEEN SolutionTM. This new innovative method has been shown to enable that those lungs that previously had been deemed not usable, were usable after performing perfusion with STEEN SolutionTM when the organ was taken out of the donor’s body. The use of STEEN SolutionTM has therefore the potential to significantly increase the number of lungs available for transplantation, something that could be lifesaving for many patients since there today is a lack of available organs to transplant.
“The submission of the application to the FDA for market approval is a milestone in the clinical and commercial development of Vitrolife’s unique and innovative STEEN SolutionTM” says Magnus Nilsson, head of Vitrolife’s subsidiary Xvivo Perfusion AB that focus on developing and commercializing products for organ transplantation.
If the application is approved by the FDA, it is estimated that sales in the USA can commence in the end of 2012 whereafter Xvivo Perfusion AB can start marketing STEEN SolutionTM and other products related to the clinical use of STEEN SolutionTM that the company has developed.
July 10, 2012 Gothenburg, Sweden VITROLIFE AB (publ) Thomas Axelsson CEO