First transplantation of lungs using Steen solution carried out in
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
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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