A syringe filled with an expandable, multi-sponge dressing may just be the answer to saving lives. The U.S. Food and Drug Administration (FDA) has just approved the use of XSTAT 30 for paramedics and other first responders.
RevMedx XStat® 30mm is a device that contains 92 compressed cellulose sponges that will absorb 276 milliliters of blood or exudate. The device was formerly limited to military use only, but now with the FDA approval, it will be used on life-threatening bleeding from wounds in areas where a tourniquet cannot be placed (such as the groin or armpit).
“Wounds suffered in the junctional area, including the pelvis or axilla (shoulder), are considered ‘non-compressible wounds,’ and often lead to uncontrolled bleeding and the death of the patient. XStat 30 is a rapid deployment device that can treat many non-compressible wounds and help save lives on the battlefield,” RevMedx wrote on its website.
The earlier first responders can control severe bleeding the better it is in preventing shock, and XSTAT 30 will help to save more lives. Thirty 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, according to the United States Army Institute of Surgical Research.
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Acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health William Maisel, M.D., M.P.H., said in a statement: “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.
“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 has only been cleared for patients who are at a high risk for immediate, life-threatening, and severe hemorrhagic shock and non-compressible junctional wounds, and only when definitive care at an emergency care facility cannot be achieved within minutes, according to the FDA press release.
Andrew Barofsky, CEO and President of RevMedx Inc., said on their website: “We are pleased to have reached this important milestone of launching XSTAT. We designed the XSTAT with direct input from military medics and first responders to provide a unique solution to the issue of junctional hemorrhage.”
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 FDA wrote in a statement.
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 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 added.
Watch this video from CNN about XSTAT 30 being used on the battlefield:
XSTAT is the first of its kind and “consists of a 30mm diameter syringe filled with compressed mini-sponges that, when in contact with blood or fluid, expand up to 10x their size. These sponges are designed to create a temporary barrier to blood flow and provide hemostatic pressure until the patient can receive surgical care. Each mini-sponge contains a radiopaque marker for easy detection with x-ray imaging,” the maker said on its website.
“We are looking forward to creating new and exciting products based on the XSTAT concept,” Barofsky said.