CAUTION: Investigational device. Limited by federal law to investigational use.
XStat is an investigational hemostatic dressing under development by RevMedx for the control of severe bleeding from pelvis or shoulder wounds not amenable to tourniquet application in adults and adolescents.
XStat works by applying a group of small, rapidly-expanding sponges into a wound cavity using a lightweight applicator. 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 sponges are composed of standard medical sponge that is coated with a hemostatic agent and compressed. Each Xstat sponge contains a radiopaque marker for easy detection via X-ray.
In the wound, the Xstat sponges expand and create a barrier to blood flow, present a large surface area for clotting, and provide gentle pressure. No direct manual pressure is required.
In a preclinical model with aggressive non-compressible hemorrhaging, Xstat provided statistically significant improvement in hemostasis and survival 60 minutes after injury with a large reduction in blood loss, resuscitation fluid requirement, and medic treatment time compared to conventional hemorrhage control dressings.
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 is designed to treat narrow wound tracks. The single-use device consists of a 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.