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Recently approved by the FDA, the XStat® is a first-in-kind hemostatic device for the treatment of gunshot and shrapnel wounds on the battlefield. XStat works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator.
Each sponge contains an x-ray detectable marker. In the wound, the XSTAT sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood.
The compact XStat-30™ applicator includes a telescoping handle and a sealed valve tip.
The telescoping mechanism allows the handle to be stored in a shortened state to maximize compactness.
The applicator tip is designed to prevent fluid ingress and minimize the risk of premature sponge expansion.
This creates a temporary barrier to blood flow and provides hemostatic pressure.
“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 sponges work fast: In just 15 seconds, they expand to fill the entire wound cavity, creating enough pressure to stop heavy bleeding.
And because the sponges cling to moist surfaces, they aren’t pushed back out of the body by gushing blood. “By the time you even put a bandage over the wound, the bleeding has already stopped,”
Indications for Use:
XStat is a hemostatic device for the control of bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.
XStat is a temporary device for use up to four (4) hours until surgical care is acquired. XStat® is intended for use in the battlefield.
XStat IS NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.
US Patent 8,828,050 B2
X STAT Non-absorbable, expandable, hemostatic sponge for temporary internal use!
HELLENIC REPUBLIC CERTIFIED NATO NCAGE CODE G2181 UNGM 400640