A couple months ago we reported on a new device from RevMedx, out of Wilsonville, Oregon, specifically designed to treat gunshot wounds. The XStat Rapid Hemostasis System is basically a huge injector syringe with what look like tablets inside, that are actually sponges that expand once in the wound. The sponges are coated with a hemostatic agent and have a radiopaque marker attached for easy removal later under X-ray imaging. The wound can be plugged in less than fifteen seconds, allowing hemostasis and blood clotting to begin around the sponges.

The FDA has just issued approval for the Xstat to be used by the U.S. military, but only on areas of the body where a tourniquet would be inappropriate. It’s indicated for up to four hours of use, which should allow ample time to get a wounded soldier to a battlefield surgeon.

From the FDA’s announcement:

According to the U.S. Army Medical Department, Medical Research and Materiel Command, since mid-World War II, nearly 50 percent of combat deaths have been due to exsanguinating hemorrhage (bleeding out). Of those, half could likely have been saved if timely, appropriate care had been available. The device consists of three, syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating. The sponges expand and swell to fill the wound cavity, after approximately 20 seconds upon contact with water from blood or bodily fluid. This creates a temporary physical barrier to blood flow. The number of sponges needed for effective hemorrhage control will vary depending on the size and depth of the wound. Up to three applicators may be used on a patient. The tablet-shaped sponges are each 9.8 millimeters in diameter and 4 to 5 millimeters in height. They can absorb 3 milliliters of blood or body fluid. An applicator filled with 92 sponges, therefore, can absorb about 300 milliliters of fluid.

Flashback: XStat Rapid Hemostasis System for Gunshot Wounds Works in 15 Seconds…

Product page: XStat…

Press release: FDA allows marketing for first-of-kind dressing to control bleeding from certain battlefield wounds…