Traumatic injury medical devices developer Innovative Trauma Care (iTraumaCare) has obtained 510(k) clearance from the US Food and Drug Administration (FDA) to market its iTClamp hemorrhage control system in the country.
iTClamp controls severe bleeding within seconds and helps prevent death due to traumatic injury.
The function of the device is to seal the edges of a wound, creating a temporary pool of blood under pressure. The resulting clot helps in controlling blood loss until the patient is provided with surgical assistance.
The product was awarded the CE Mark in Europe in March 2013 and was licensed for sale in Canada in late 2012. The company says it will be available in the US within the next one to two months.
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."
The iTClamp hemorrhage control system, which is iTraumaCare’s first product, is classified as a Class II medical device.
