The U.S. Food and Drug Administration
has cleared the use of the XSTAT 30 wound dressing device to control severe, life-threatening bleeding from wounds in battlefield as well as for civilian purposes.
The syringe-shaped device shoots little sponges into the wound. They expand to as much as 10 times their size to fill the space and stop the bleeding for up to four hours – until a surgeon can get to work.
The device can help in preventing a large number of deaths in emergency situations.
The $100 syringe can be used in patients at high risk for immediate, life-threatening, and severe hemorrhagic shock and non-compressible junctional wounds, where emergency care facility is not available instantly.
The number of sponges needed for effective hemorrhage control will depend on the size and depth of the wound. Each applicator can absorb about a pint of blood.
According to the USFDA, between 30 and 40 per cent of trauma deaths are caused by bleeding, and of these deaths, 33 to 56 per cent occur before the patient reaches a hospital. In the case of a battlefield, it is worse, as 86 percent of all military personnel killed in battle die within 30 minutes of being wounded.
“When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available,” said the FDA’s Dr. William Maisel.
The USFDA said the device can be used where a large dressing would be useless -for instance, in the groin or armpit. “XSTAT 30 is not indicated for use in certain parts of the chest, abdomen, pelvis or tissue above the collarbone,” the USFDA added.
According to its makers, RevMedX, Inc., in Wilsonville, Oregon, there is a little marker in each mini-sponge that makes it show up on an x-ray. This means that they are easy to detect if left behind during emergency surgery. The device is available in packages of one or three syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating.