Traumatic injury medical devices developer iTraumaCare has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its iTClamp Hemorrhage Control System.
iTClamp is designed to control severe bleeding, in seconds, and help prevent death due to traumatic injury.
The device seals the edges of a wound to create a temporary pool of blood under pressure. This forms a stable clot controlling blood loss until the patient is provided with surgically assistance.
Licensed for sale in Canada in late 2012 and awarded CE Mark for sale in Europe in March 2013, the product will be available in the US in 30 to 45 days, the company said.
iTraumaCare CEO and founder Dr. Dennis Filips, said, "With this regulatory milestone achieved, we look forward to putting the iTClamp in the hands of health care professionals in the United States and improving patient care."
Classified under Class II medical devices, iTClamp is iTraumaCare’s first product.