Battlefield Wound Dressing (XSTAT-30 ) Okayed for Civilian Use

December 07, 2015

A novel wound dressing now used to control severe bleeding on the battlefield will be available to civilian first responders treating trauma patients, the US Food and Drug Administration (FDA) has announced.

The agency today cleared XSTAT-30 (RevMedX) wound dressing for patients at high risk for immediate, life-threatening, and severe hemorrhagic shock and noncompressible junctional wounds when they can't be treated at an emergency-care facility within minutes. XSTAT-30 is not indicated for certain parts of the chest, abdomen, pelvis, or tissue above the collarbone, according to an FDA news release.

The wound dressing product consists of a syringe-style applicator holding 92 compressed cellulose sponges with an absorbent coating. The sponges expand with blood and fluid to fill the wound cavity, temporarily blocking blood flow for up to 4 hours. Each applicator's worth of sponges can absorb about one pint of blood, although the number of sponges needed to control bleeding will vary by the size and depth of the wound.

The FDA cited research by the US Army showing that 30% to 40% of civilian deaths from traumatic injury result from hemorrhaging, often before the patient reaches the hospital.

The FDA approved an earlier version of the product — XSTAT — for military use in April 2014. Will Fox, vice president of sales and marketing at RevMedX, said his company had always envisioned a civilian application for the blood-absorbing sponges. People injured in car wrecks, industrial accidents, and shootings have the same kind of severe wounds seen on the battlefield, Fox told Medscape Medical News.

The agency limited the initial product to military use last year to give it a trial run before expanding the indication, he said.

The FDA cleared XSTAT-30 through its 510(k) review process, in which the manufacturer showed that the product was substantially equivalent to its XSTAT predecessor in terms of safety and effectiveness.

More information on today's FDA decision is available on the agency's website.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.