XSTAT 12 is designed to treat life-threatening bleeding from penetrating wounds in junctional areas that may be too narrow to access with the XSTAT 30.
XSTAT 12 is a first-in-kind hemostatic device for the treatment of gunshot and
shrapnel wounds. It is designed to treat life-threatening bleeding from
penetrating wounds in junctional areas that may be too narrow to access.
XSTAT devices work by injecting a group of small, rapidly-expanding sponges
into a wound cavity using a syringe-like applicator. In a wound, the sponges
rapidly expand and exert hemostatic pressure. Each sponge contains an x-ray
detectable marker to confirm complete surgical removal. It enables treatment
of penetrating trauma from smaller caliber bullets, stab wounds and other lifethreatening injuries that require immediate treatment.
Indications for Use
XSTAT is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla and bleeding from narrow entrance extremity wounds in the arms or legs 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. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non- compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.
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.
The XSTAT device is designated as a “Prescription Only” device, to be used by physicians and/or trained medical professionals only