Medical device firm iTraumaCare, an early-stage medical device firm focused on developing traumatic injury solutions, has achieved its fifth 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 neck. Previously, the product’s indications for use in the US included the extremities (arms and legs), axilla (arm pit), inguinal (groin) areas and the scalp.
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 that mitigates further blood loss until the wound can be surgically repaired.
iTraumaCare’s Founder and Chief Medical Officer, Dr. Dennis Filips, said, "Addressing difficult to control hemorrhage in the neck has been a consistent problem with few solutions. This expanded indication for the iTClamp will allow first responders, medical professionals and tactical and battlefield medics to use the device in even 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 is addressing unmet needs in the field of emergency medicine by developing, manufacturing, and commercializing solutions to treat common causes of preventable death in traumatic injury scenarios.