FDA clears syringe-like device to dress wounds

Posted at 2:55 PM, Dec 10, 2015
and last updated 2015-12-10 14:55:05-05

The U.S. Food and Drug Administration has cleared a traumatic wound dressing device for use by the general public.

The XSTAT 30 had previously been approved for use in the military to treat life-threatening wounds. 

With the XSTAT 30, a group of small, rapidly-expanding sponges are injected into a gaping wound, creating a temporary barrier to blood flow, according to RevMedX, an Oregon-based company that makes the XSTAT 30. 

The FDA notes that the dressing can be used for up to four hours and each applicator can absorb about a pint of blood. The XSTAT 30 is not for use in "certain parts of the chest, abdomen, pelvis or tissue above the collarbone." 

“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, in a press release. “It is exciting to see this technology transition to help civilian first responders control some severe, life-threatening bleeding while on the trauma scene.”
Watch the video above for a demonstration of how the XSTAT 30 works. Note: The simulation is graphic.