First transplantation of lungs using Steen solution carried out in North America

27 October 2008

Swedish company Vitrolife (STO: VITR) has announced that lung transplantations using its Steen Solution technology have been carried out in North America. The transplantations were performed in Toronto, Canada, and are part of the study that is being carried out as a basis for the application for sales approval in the USA and Canada.

“It is very good to be able to observe that three further patients with lung disease have been able to be helped by means of this new technology, that it has been adopted by North America’s most experienced lung transplantation clinic and that the clinical study involving our unique product is now well underway,” said Magnus Nilsson, Vitrolife’s CEO.

At the beginning of September Vitrolife announced that approval had been received from the Canadian authorities to start a study with Steen Solution. The study, which has been designed in consultation with the American FDA, is planned for quarters three to four of 2008 and will be the key element in the application for sales approval in USA and Canada. It is within the framework of this study that the first three transplantations have now been carried out in Toronto in Canada.

Vitrolife says that the first lung transplantation outside Sweden using the Steen Solution technology was recently performed in one of the large EU countries and that within the region there are a further number of clinics in the starting blocks, ready to use the technology. Earlier on in the development and the first clinical use eight transplantations were carried out using STEEN Solution at the University Hospital of Lund, where this pioneering technology was developed under the leadership of Professor Stig Steen.

Vitrolife’s 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 at normal body temperature before possible use.

With the Steen Solution method, the number of potential organs that can be transplanted increases considerably. In the USA, for example, less than 20 percent of the lungs donated are transplanted today, due to uncertainty about the function of the organ. In time the Steen Solution method can lead to a fivefold to tenfold increase in the number of lung transplantations carried out, as the need for donated organs using today’s methods considerably exceeds supply.

Steen Solution has already been approved for sales in Europe and Australia. The patent has so far been approved in Australia and the USA.


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