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news.Vitrolife, a global biotechnology and medical device group, has received approval from the Canadian authorities to start a study with Steen Solution.
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The study, which has been designed in consultation with the FDA, is planned for quarters three to four of 2008 and will be the key element in the application for sales approval in the US and Canada.
Vitrolife’s product Steen Solution is part of a new method for functional testing and preservation of lungs outside the body. The technology makes it possible for the first time to test the function of donated lungs outside the body by pumping Steen Solution into the organ’s system of vessels before possible use.
Steen Solution has already been approved for sale in Europe and Australia. The patent has so far been approved in Australia and the US.