“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.”
Here’s how the XSTAT 30 works. The device is essentially an oversized syringe filled with no less than 92 compressed sponges — but these aren’t just any old sponges. These particular sponges are made from plant cellulose and coated in chitosan, an amazing antimicrobial compound found in crustacean shells.
When inserted into a wound, the sponges quickly absorb any outpouring blood and expand to fill the wound. Not only does this create pressure that helps quell the flow, but the chitosan-coated sponges also supercharge the blood-clotting process, which in turn makes them even more effective at stopping further bleeding. In most situations, the XSTAT 30 can completely plug up a bleeding wound in 20 seconds or less, and typically lasts up to four hours — which gives the injured person time to seek medical attention and surgery if required.
This is a big deal, for obvious reasons. Early control of severe bleeding can help prevent an injured person from going into shock, which drastically increases their chances of survival. 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. Of those deaths, 33 to 56 percent occur before the patient reaches a hospital.”
There’s currently no word on when/where the XSTAT 30 will be available for purchase, but the newly-granted FDA approval means that sometime soon first responders and other health care providers will have access to this revolutionary device.
