FDA Expands Use of Blood Control Device to Scalp

The U.S. Food and Drug Administration (FDA) has approved an expanded use of a blood control device made by early-stage medical device firm iTraumaCare.

The agency is allowing the company’s iTClamp Hemorrhage Control System to be used to control severe scalp bleeding. The device already is approved to control bleeding in the arms, legs, groin and arm pit.

The iTClamp is designed to control severe bleeding – a leading cause of death in traumatic injury – in seconds, according to the Canadian company. The iTClamp seals the edges of a wound closed to create a temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can surgically be repaired.

“The scalp is often one of the bloodiest wound sites, with uncontrolled bleeding becoming a major issue in patient treatment,” iTraumaCare CEO/founder Dr. Dennis Filips said, “This expanded indication will allow first responders and medical professionals to use the iTClamp in more meaningful ways to improve patient care.”

Incorporated in 2010 and based in Edmonton, Canada, with its global commercialization headquarters in San Antonio, Texas, iTraumaCare develops, manufactures and commercializes solutions to treat traumatic injuries.