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FDA Clears Military Wound Dressing for Civilian Use
The FDA has approved the use of the XStat-30 wound dressing (RevMedX, Inc.), an expandable, multisponge dressing used to control severe, life-threatening bleeding from wounds in areas where 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 only by the military 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% of civilian deaths by traumatic injury are the result of bleeding. Of those deaths, 33% to 56% occur before the patient reaches a hospital.
XStat-30 was approved for use in patients at high risk for immediate, life-threatening, and severe hemorrhagic shock and noncompressible 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.
The dressing can be used for up to 4 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. The number of sponges needed for effective hemorrhage control will vary, depending on the size and depth of the wound. Each applicator can absorb about a pint of blood, and up to three applicators may be used on a patient.
The FDA cleared XStat-30 through the 510(k) review process after the manufacturer demonstrated that the product was substantially equivalent to XStat, which was granted marketing authorization for battlefield use in April 2014.
Source: FDA; December 7, 2015.