Sponge Hemostatic Agent

Non-absorbable, expandable, hemostatic sponge for temporary internal use.

NSN 6510-01-632-9440

XStat® is a first-in-kind hemostatic device for the treatment of gunshot and shrapnel wounds. XStat works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. Each sponge contains an x-ray detectable marker. In the wound, the XSTAT sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood. This creates a temporary barrier to blood flow and provides hemostatic pressure.

“When a product is developed for use in the battlefield, it is generally intended to work in a worst­case 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, life­threatening bleeding while on the trauma scene.”

Indications for Use:

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.