The XStat 30, a sponge-filled syringe that can plug deep and narrow wounds from gunshots or stabbings in seconds, has received approval from the U.S. for use in the arm and leg.
The FDA also gave RevMedx, the Oregon-based company that makes the device, approval to market a smaller version, the XStat 12, which is designed to treat smaller wounds from a stabbing or smaller caliber firearm. Andrew Barofsky, the CEO of manufacturer RevMedx, said the FDA’s decision would advance the company’s mission “to reduce death and disability from traumatic bleeding injuries caused by war, violence, or accidents.”
The device has been used on the battlefield and in civilian hospitals since it launched in 2014, aided by a $5 million grant from the U.S. Army. But its first approval in 2015 by the Food and Drug Administration kept its use among civilian first responders limited to areas like the groin and armpits, where it can be difficult to treat a wound with a gauze tourniquet.
The green light could help civilian first responders prevent gunshot victims from bleeding to death while en route to an emergency facility. Data from the United States Army Institute of Surgical Research suggests 30% to 40% of civilian traumatic injury deaths are due to blood loss. Of those, it’s estimated that 56% occur before the patient reaches an emergency care facility.
The XStat devices, which reportedly cost about $100 and are only available by prescription, contain small, expandable cellulose sponges designed to expand to 15 times their size when they come in contact with blood. As with gauze bandages designed for surface wounds, that’s meant to create a barrier to blood flow, present a large surface area for clotting, and apply pressure to the wound. The sponges are also marked such that an X-ray can detect them, allowing surgeons to more easily remove them later.
Other “hemostatic” devices use a similar method to address surface wounds. Celox A, a syringe-like applicator filled with granulated Celox gauze, has been used by military, trauma crews, and law enforcement for dealing with smaller surface wounds (it’s now about $20 on Amazon).
You can see how the XStat is used to plug a very realistic-looking knife wound in seconds in this video: