The U.S. Food and Drug Administration has cleared the use of
the XSTAT 30—an innovative sponge-filled gunshot wound dressing device—for
use in the general population. Approved last year for battlefield use, the
device can plug a gunshot wound in just 15 seconds.
The XSTAT Rapid Hemostasis System is an expandable, multi-sponge dressing that’s used to control severe, life-threatening bleeding from wounds in bodily areas where a traditional tourniquet is of no use, such as the groin or armpit. It works by pumping expandable, tablet-sized sponges into the wound, staunching bleeding while a patient is rushed to hospital.
The tablets are standard medical sponges that expand on contact with blood, and the dressing lasts for about four hours. Each applicator absorbs about a pint of blood, and up to three applicators can be used on a patient. To assist with extraction, each tablet contains a radioplaque marker that can be spotted under an X-ray.
XSTAT was originally developed for the military, but the FDA says first responders can now use the device to treat adults and teens in the general population who are experiencing life-threatening and severe hemorrhagic shock.
Early control of severe bleeding is critical. The U.S. Army Institute of Surgical Research says that 30-40% of civilian deaths by traumatic injury are the result of hemorrhaging, and 33-56% of those deaths happen before the patient reaches a hospital.
“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 Dr. William Maisel in a FDA release. “It is exciting to see this technology transition to help civilian first responders control some severe, life-threatening bleeding while on the trauma scene.”
The FDA’s guidelines specify that the device is only to be used when
“definitive care at an emergency care facility cannot be achieved within
minutes,” and is not to be used in certain parts of the chest, abdomen,
pelvis, or tissue above the collarbone.
Approval was granted after the manufacturer, RevMedX, successfully demonstrated that its civilian model was essentially the same as its military version, which was approved in April 2014.
Guns in the United States kill about 33,000 people annually, of which some 20,000 are suicides and 11,000 are homicides. This year alone, the United States has experiences 462 mass shootings. So the announcement of the XSTAT 30’s approval comes at a time when they appear to be most needed.