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FDA NEWS RELEASE

For Immediate Release: April 3, 2014
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

 

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

Today, the U.S. Food and Drug Administration allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care.

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. 

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.

“XSTAT is a novel device that can be rapidly deployed, providing fast-acting hemorrhage control to stabilize a wounded patient for transport,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “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.”

The FDA reviewed XSTAT through its de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind.

The FDA’s review of the XSTAT submission included animal studies demonstrating its effectiveness at stopping bleeding and the absorption capacity of the device. In addition, non-clinical biocompatibility data and human factors testing were provided to demonstrate the safety and usability of the device.

The XSTAT is manufactured by RevMedX, Inc., in Wilsonville, Ore.

For more information:

FDA: Medical Devices 
U.S. Army Medical Department, Medical Research and Materiel Command 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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