Rapid Hemostasis System for Gunshot Wounds

The XStat device is a syringe-like applicator that injects tablet-sized sponges into wounds that are not amenable to tourniquet application. The sponges, which are standard medical sponges coated with a hemostatic agent and then compressed, expand once they come in contact with liquid, rapidly filling a substantially larger volume than their compressed state. Besides helping to block blood flow, the sponges also provide a surface on which blood can begin to clot. And because the sponges have to be eventually removed, each has a tiny radiopaque marker so that any remaining in the body can be spotted on X-ray.

Two applicator sizes are under development: a 30 mm diameter applicator for larger wounds and a 12 mm diameter applicator for narrow wound tracks. The XStat-30 applicator includes a telescoping handle that can be stored in a shortened state to maximize compactness, as well as a sealed valve tip designed to prevent fluid ingress and minimize the risk of premature sponge expansion. The XStat-12 applicator consists of a narrower cylindrical applicator body with a frangible tip and a detachable plunger. The applicator body includes a finger flange with snap-fit features to secure multiple devices for low-profile packaging and storage.

In a preclinical model with aggressive noncompressible hemorrhaging, the Xstat devices provided statistically significant improvement in hemostasis and survival 60 minutes after injury even with a large reduction in blood loss, resuscitation fluid requirement, and medic treatment time, compared to conventional hemorrhage control dressings. The XStat devices are products of RevMedx (Wilsonville, OR, USA), and are currently an investigational product in the United States.

“It's primarily intended for deep wounds with heavy bleeding inside, with no way of putting direct pressure on the wound, and no way to wrap a tourniquet around it,” said Anthony Pusateri, PhD, portfolio manager of the US Department of Defense (Washington DC, USA) Hemorrhage and Resuscitation Research and Development Program. “Basically, it's designed for use in the axillary and inguinal regions, or the junction of the legs and arms with the torso - too high for a tourniquet and too deep for a dressing.”

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