XSTAT 30 Wound Dressing Approved by FDA for Civilian Use
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XSTAT 30 Wound Dressing Approved by FDA for Civilian Use

December 8, 2015

The Food and Drug Administration (FDA) has issued an approval of a military-grade wound dressing for civilian use.

The dressing is the XSTAT 30, 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). Early control of severe bleeding can prevent shock and can be live-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, 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."

The dressing can be used for up to four hours, which could allow time for the patient to receive surgical care. The device is available in packages of one or three syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating. The sponges expand and swell to fill the wound cavity, creating a temporary physical barrier to blood flow. Each applicator can absorb about a pint of blood.

The FDA approval clears XSTAT 30 to be used 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 manufactured by RevMedX, Inc.