FDA
Approves Device That Can Plug Gunshot Wounds in 15 Seconds
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.
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