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.