An Oregon company recently won approval from the Food and Drug Administration (FDA) for XStat, a hemostatic device for treating gunshot and shrapnel wounds on the battlefield.
RevMedX of Wilsonville, Ore., developed XStat to control bleeding in body areas like the groin, which are not amenable to the application of a tourniquet.
XStat works by injecting a group of small, rapidly expanding sponges into a wound cavity using a syringe-like applicator. In the wound, the sponges expand and swell to fill the cavity within 20 seconds of contact with blood, creating a temporary barrier to blood flow and providing hemostatic pressure.
John Steinbaugh, RevMedX’s vice president of strategic development, says XStat traces its beginnings to a combat dressing invented by Oregon Biomedical Engineering Institute (OBEI). U.S. Special Operations Command (USSOCOM) wanted the organization to develop a combat pressure dressing, so OBEI formed RevMedX to handle the final development and production of XStat, he says.
XStat comes in two versions — XStat-30 for large shrapnel or rifle round wounds and XStat-12 for pistol round or smaller shrapnel wounds, Steinbaugh says. Steinbaugh is a retired U.S. Army master sergeant with 25 years’ experience, 20 of them as a Special Forces medic with more than 50 months of combat experience during his career.
XStat-30 is 5-1/4-inches long and designed so the device’s handle stores inside the applicator. XStat-12 is a smaller device that uses the same sponge size but comes in a pack of three, which are equal to one XStat-30.
“The handle is a stainless-steel rod about 7/8-inch in diameter that slides inside the tube, but when you pull it back it locks onto open onto a disc,” Steinbaugh says. “The tip of the XStat opens like a valve, so there’s no prep needed on the part of the medic.”
Steinbaugh points out the XStat uses a proprietary type of sponge that’s compressed down to about 3 mm in size from its 50-mm original size.
“When it makes contact with fluid, such as blood in a groin wound, it expands to 15 times its size, jamming tightly into the bleeding wound,” Steinbaugh notes. “It applies very firm force to the walls of the wound, which applies constant pressure to the artery.”
Steinbaugh says the big difference between XStat and other combat gauze products is that with other gauzes, when the medic takes his hand away there’s no more pressure on the wound and bleeding resumes. The medic has to hold pressure on other gauze products until the wound clots.
Because XStat expands and puts its own pressure on the wound, he says, if the wound begins to re-bleed, the blood will hit sponges that haven’t already expanded, which will stop the re-bleed. Only about one-third of XStat’s sponges expand on initial contact with a bleeding wound.
Steinbaugh says RevMedX is in the process of ramping up manufacturing and “is working hand-in-hand with the U.S. Army so we can deliver enough product for them. USSOCOM will get the first order.”
RevMedX also has spun off the technology to develop X-Gauze, which uses the same sponge technology embedded into gauze. It can be used on any wound where it’s necessary to pack gauze to stem bleeding and has similar pressure qualities to XStat. Steinbaugh envisions X-Gauze versions being developed for the U.S. military, law enforcement and emergency medical services (EMS) use.
About the author: Alan M. Petrillo is a Tucson, Ariz., journalist who writes for national and regional magazines and newspapers. He’s also the author of the mystery, Full Moon, books on historical military small arms, and the nonfiction work, Ice Hockey in the Desert.