FDA Clears Traumatic Wound Treatment for Civilian Use

Citing the U.S. Army Institute of Surgical Research, FDA reported 30-40 percent of civilian deaths by traumatic injury result from bleeding, and of those deaths, 33 to 56 percent occur before the patient reaches a hospital.

The U.S. Food and Drug Administration has approved use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds where a tourniquet cannot be placed for adults and adolescents in the general population. Until this week, it was approved for military use only.

Citing the U.S. Army Institute of Surgical Research, FDA reported 30-40 percent of civilian deaths by traumatic injury result from bleeding, and 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 Dr. William Maisel, M.D., MPH, acting director of the Office of Device Evaluation in 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," he added.

XSTAT 30 is now 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. It is not indicated for use in certain parts of the chest, abdomen, pelvis, or tissue above the collarbone, according to the agency, which said the dressing can be used for up to four hours, which could allow time for the patient to receive surgical care. FDA cleared it through the 510(k) review process after the manufacturer demonstrated the product was substantially equivalent to the XSTAT, which was granted marketing authorization for battlefield use in April 2014.

XSTAT 30 is manufactured by RevMedX, Inc., in Wilsonville, Ore.

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