iTraumaCare, an early-stage medical device firm focused on developing traumatic injury solutions, has achieved its fourth regulatory milestone with an expanded indication for use from the US Food and Drug Administration (FDA).
The regulatory body has expanded the indications for the company’s first product, the iTClamp hemorrhage control system, to include the temporary control of severe bleeding of the scalp.
Previously, the product’s indications for use in the US included only the extremities (arms and legs), axilla (arm pit) and inguinal (groin) areas.
The iTClamp is designed to control severe bleeding – a leading cause of death in traumatic injury – in seconds. 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 be surgically repaired.
iTraumaCare CEO and founder Dr Dennis Filips noted the scalp is often one of the bloodiest wound sites, with uncontrolled bleeding becoming a major issue in patient treatment.
"This expanded indication will allow first responders and medical professionals to use the iTClamp in even more meaningful ways to improve patient care," Dr Filips added.