RevMedx, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the use of the XSTAT 30 wound dressing in both 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."
Early control of severe bleeding may prevent shock and may be life-saving. The United States Army Institute of Surgical Research reports that 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 an emergency care facility.
XSTAT is a first-in-kind hemostatic device for the treatment of severe bleeding in the axilla or groin area (known as junctional wounds). XSTAT works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. In a wound, the sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood. This process creates a temporary barrier to blood flow and provides hemostatic pressure. Each sponge contains an x-ray detectable marker to aid in surgical removal.
"We are pleased to receive this additional clearance for XSTAT, which now brings to bear new capabilities to civilian first responders" said Andrew Barofsky, CEO and President of RevMedx Inc. "With this clearance, XSTAT’s life-saving technology can now be used in a variety of settings by trained medical personnel" said Barofsky.