“Today, the U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication from use by the military only to use in adults and adolescents in the general population. Early control of severe bleeding may prevent shock and may be life-saving. According to the United States Army Institute of Surgical Research, 30 to 40 percent of civilian deaths by traumatic injury are the result of hemorrhaging. Of those deaths, 33 to 56 percent occur before the patient reaches a hospital. “When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “It is exciting to see this technology transition to help civilian first responders control some severe, life-threatening bleeding while on the trauma scene.” XSTAT 30 is cleared for use in patients at high risk for immediate, life-threatening, and severe hemorrhagic shock and non-compressible junctional wounds, when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT 30 is not indicated for use in certain parts of the chest, abdomen, pelvis or tissue above the collarbone..”