The FDA approved 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 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.
"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.”
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.