The European Union (EU) has granted CE mark approval to iTraumaCare's iTClamp Hemorrhage Control System, designed for controlling critical bleeding in seconds.
The device seals the edges of a wound to create a temporary pool of blood under pressure and form a stable clot that mitigates further blood loss until the wound can be surgically repaired.
iTraumaCare CEO and founder Dennis Filips said, "We are delighted with the rapid acceptance of the iTClamp and look forward to launching in Europe soon."
The company said the iTClamp, which was licensed for sale in Canada in late 2012, will be available to medical professionals in participating EU countries within 30 to 45 days.
It is expected that the product will be cleared by the US Food and Drug Administration in 2013.
Canada-based iTraumaCare develops, manufactures and commercializes emergency medicine to treat common causes of preventable death in traumatic injury scenarios.
