FDA Clears Military Traumatic Wound Dressing for Civilian Use

XSTAT 30 is an expandable, multi-sponge dressing that has been used on the battlefield to control severe, life-threatening bleeding that is non-compressible (in locations like the torso, groin or armpit where a tourniquet cannot be placed). The FDA’s clearance yesterday expands the device’s indication from use in military settings only to use in adults and adolescents in civilian settings.

“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., in the FDA’s press release on the clearance. Maisel is acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

XSTAT 30 may now be used in patients at high risk for severe hemorrhagic shock and non-compressible wounds when definitive care at an emergency care facility cannot be achieved within minutes.

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