Non-absorbable, expandable, hemostatic sponge for temporary internal use.
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. 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.”
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.
XStat-30™ is currently in pre-production and will be available for battlefield use later this year.
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.
The XStat-12™ applicator for narrow wound tracts is currently under development. The applicator body includes a frangible tip, a detachable plunger and a finger flange with snap-fit features to secure multiple devices for low-profile packaging and storage.
CAUTION: Investigational device. Limited by federal law to investigational use.