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XSTAT® is a first-in-kind hemostatic device for the treatment of gunshot and shrapne
injecting a group of small, rapidly-expanding sponges into a wound cavity using a syr
sponge contains an x-ray detectable marker. In the wound, the XSTAT sponges expa
cavity within 20 seconds of contact with blood. This creates a temporary barrier to blo
hemostatic pressure.
“When a product is developed for use in the battlefield, it is generally intended to wor
where advanced care might not be immediately available,” said William Maisel, M.D.
Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
technology transition to help civilian first responders control some severe, life-threate
trauma scene.”
XSTAT 30 is a temporary device for use up to four (4) hours until surgica
be used for patients at high risk for immediate life-threatening bleeding f
significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic sho
junctional wounds, and when definitive care at an emergency care facilit
minutes
XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the
retroperitoneal space; the sacral space above the inguinal ligament; or t
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2/27/2018 XSTAT | United States | RevMedx, Inc.
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