FDA clears lifesaving device that can plug bullet wounds in seconds
The FDA has cleared a lifesaving military device for civilian use. The XSTAT 30 created by RevMedX is expandable, multi-sponge filled syringe used to control life-threatening bullet wounds. It has been in use by the military since April 2014.
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The device contains 92 tablet-sized sponges that expand upon contact with blood. The syringe can stop bleeding within 15 seconds allowing the injured to be rushed to the hospital without hemorrhaging.
A FDA press release notes that according to the United States Army Institute of Surgical Research, 30 to 40 percent of civilian deaths by traumatic injury are the result of hemorrhaging and 33 to 56 percent of those deaths occur before the patient reaches a hospital.
"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."
Although the device has been cleared for civilian use, the XSTAT 30 is to only be used in patients at high risk for immediate, life-threatening, and severe hemorrhagic shock when care at an emergency care facility cannot be quickly achieved.
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