FDA approves device to stop gunshot wound bleeding in 15 seconds

SILVER SPRING, MARYLAND — The U.S. Food and Drug Administration has approved the civilian use of the XSTAT Rapid Hemostasis System, which can stop the bleeding from an open gunshot wound in 15 seconds. The device had already been in use by the military after being approved for use in the battlefield in 2014. 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 said: "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 XSTAT 30 is for use with patients who have life-threatening hemorrhagic shock, when emergency medical care cannot be found in minutes. The treatment uses a syringe-style applicator to puts tablet-sized cellulose sponges into the wound to absorb blood and stop the bleeding. Each XSTAT 30 syringe has 92 sponges that can absorb a pint of blood. The dressing is effective for up to four hours, while the patient seeks further medical attention. Up to three applicators can be used on an individual patient. The sponges have radioplaque markers so an X-ray can pick up any sponges to help in the process of extraction.

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