FDA Clears XSTAT to Stop Gun and Knife Wounds in Arms and Legs
RevMedX secured FDA 510(k) clearance for XSTAT 12 and XSTAT 30 devices used to stop severe bleeding from knife and gun-shot wounds in the arms or legs.
The devices are large syringes that quickly push dozens of tablet-sized highly absorbent pieces of foam into a wound. Once the foam tablets are inside the wound, they quickly expand, blocking the blood from escaping and delivering pressure onto the wound from within. Each tablet contains a radiopaque marker so it can be easily found using X-ray fluoroscopy during surgery.
The devices have previously been FDA approved for use in civilian and battlefield situations, but only to treat junctional wounds around the groin and shoulders.