For Immediate Release
December 7, 2015
Today, the U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, 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) in battlefield and civilian trauma settings. The clearance expands the device’s indication from use by the military only 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 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, 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, life-threatening bleeding while on the trauma scene.”
XSTAT 30 is 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. 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 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. 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 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.