FDA Allows Novel Battlefield Wound Treatment to Be Marketed

Since mid-World War II, nearly 50 percent of combat deaths have been due to bleeding out. Half of those likely could have been saved if timely and appropriate care had been available.

The U.S. Food and Drug Administration recently announced it has allowed the marketing of an expandable, multi-sponge wound dressing for controlling bleeding from certain types of battlefield wounds. The XSTAT is manufactured by RevMedX, Inc., in Wilsonville, Ore., and is for military use only as a temporary dressing for wounds in areas where a tourniquet cannot be placed, such as the groin or armpit. XSTAT can be used up to four hours, which could allow time for the patient to receive surgical care, according to FDA.

FDA's announcement said XSTAT was reviewed through FDA's de novo classification process for novel, low- to moderate-risk medical devices that are first-of-a-kind.

The agency cited the U.S. Army Medical Department, Medical Research and Materiel Command as the source for data showing that, since mid-World War II, nearly 50 percent of combat deaths have been due to bleeding out. "Of those, half could likely have been saved if timely, appropriate care had been available," it states.

The XSTAT 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. The sponges cannot be absorbed by the body and all sponges must be removed from the body before a wound is closed. For ease of visualization and to confirm removal of every sponge, each sponge contains a marker visible via X-ray," according to the announcement.

"XSTAT is a novel device that can be rapidly deployed, providing fast-acting hemorrhage control to stabilize a wounded patient for transport. This will be an important new treatment option for our nation's military to treat injured soldiers who may not be in close proximity to a medical facility," said Christy Foreman, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health.

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