In response to the prioritization of junctional hemorrhage control, research studies into the potential application of expanding hemostatic agents were undertaken and the injectable hemostatic XStat™ was developed, receiving FDA approval for use on the battlefield in 2014, and in civilian settings in 2015. It offers another option for controlling external hemorrhage and is best suited for deep narrow tract and junctional wounds that are otherwise difficult to compress with external pressure.

The XStat system consists of flat, circular, compressed minisponges that are coated with chitosan and packaged in an applicator. The applicator has a small-diameter insertion device available for use in narrow wound tracts. XStat is injected into the wound cavity and the compressed hemostatic minisponges expand on contact with blood. The expanded sponges, now 12–15 times their original volume, exert pressure on the walls of the wound cavity from within, thereby eliminating the need for manual compression. The chitosan may promote clotting, but the tamponade effect of the expanded sponges is the primary mechanism of action. The research studies resulting in the FDA approval were performed in animal models, although there have been case reports of its successful use in humans since then.

The FDA approval is 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 hours until surgical care is acquired. XStat is NOT approved 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.

Each XStat minisponge has a radiopaque marker so the sponges can be located with radiography at the time of surgery. Do not attempt to remove sponges in the field.

XStat is an alternative hemostatic adjunct for compressible (external) hemorrhage not amenable to limb tourniquet use or as an adjunct to tourniquet removal. XStat is best for deep, narrow-tract junctional wounds and does not require additional manual pressure once administered.

XStat is designed to control severe bleeding in traumatic wounds, particularly in situations where standard methods like direct pressure and tourniquets may be insufficient or impractical. It consists of a syringe-like applicator filled with small, expandable sponges made from a proprietary material called "ChitoSAM," which is coated with chitosan, a naturally occurring compound that promotes blood clotting.

When the XStat is applied to a bleeding wound, the sponges are inserted into the wound cavity, where they expand and exert pressure to promote hemostasis (stopping bleeding). The sponges also contain a radiopaque marker, which allows for easy identification on X-rays in case surgical removal is required.

# BENEFITS OF XSTAT

### Rapid Hemostasis

XStat provides rapid hemostasis by exerting pressure on bleeding wounds, promoting clot formation, and reducing blood loss. The expandable sponges fill the wound cavity, creating a tamponade effect and facilitating clotting.

### Ease of Application

XStat is designed for ease of use and can be quickly applied by medical personnel in high-stress environments. The syringe-like applicator allows for controlled and precise placement of the expandable sponges directly into the wound.

### Does not require Manual Pressure

XStat does not require a 3-minute period of external manual pressure on the wound after application like other hemostatic dressings and adjuncts.

### Radiopacity for Identification

XStat sponges contain a radiopaque marker, allowing for easy identification on X-rays. This feature helps locate and remove the sponges during surgical procedures if necessary.