XSTAT® P30

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XSTAT® P30 Revolutionizing the treatment of gunshot and knife wounds

CoTCC Recommended

Medical Authorization Required for Purchasing

To purchase this XSTAT® device, please complete and submit the below medical authorization form to info@panakeiausa.com.

*The XSTAT device is designated as a “Prescription Only” device, to be used by physicians and/or trained medical professionals only.

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Description

Injectable Hemostatic Device

XSTAT® is a first-in-kind hemostatic device for the treatment of gunshot and shrapnel wounds. XSTAT works by injecting small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator.

Introducing XSTAT® P30
Developed in collaboration with the US Military, the XSTAT® P30 encloses minisponges in three porous pouches to make removing sponges from wounds faster and easier. In addition, XSTAT® P30 has less packaging and a smaller cube space than the XSTAT® 30 Generation 2.

Fast Facts

  • Rapidly expanding minisponges stop bleeding using internal pressure
  • Fast-acting wound packing in seconds vs. traditional methods
  • CoTCCC recommended for compressible (external) hemorrhage not amenable to limb tourniquet use or as an adjunct to tourniquet removal, (Best for deep, narrow-tract junctional and extremity wounds)
  • XSTAT® significantly outperformed hemostatic dressings in 2017 study*

*AFSMA RDT&E study “Evaluation of XSTAT and Combat Gauze in a Coagulopathic Model of Lethal Junctional Hemorrhage”, JSOM Volume 17 Edition 3/Fall 2017

Product Specifications

  • XSTAT® is the only injectable wound treatment that immediately controls hemorrhage from penetrating wounds where other methods fail
  • Applies in seconds and stops bleeding immediately without manual compression
  • Intuitive applicator is easy to learn and easy to use
Additional information
Weight 1 lbs
Dimensions 12 × 12 × 5 in
Brand

RevMedX

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Trauma Supplies

XSTAT® Information
XSTAT®
By REVMED X logo
Injectable Hemostatic Device

Features

  • Stops bleeding in seconds with rapidly expanding sponges
  • Recommended by the Committee for Tactical Combat Casualty Care
  • Developed in collaboration with US Special Forces
  • FDA-cleared for civilian use
  • 2 size options available for large and smaller wounds
  • Mini-sponges expand up to 10x their size
  • Radio opaque marker easily visible via x-ray
How it Works

XSTAT works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. The sponges themselves are standard medical sponges that are compressed. Once they come in contact with liquid, they rapidly expand and fill a substantially larger volume than their compressed state. Besides helping block blood flow, the sponges also provide a surface on which blood can begin clotting. 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.

XSTAT How it works

Image credit: RevMedx – https://www.revmedx.com/xstat/

XSTAT® FAQS

XSTAT is a first-in-kind hemorrhage control device designed to quickly stop severe bleeding in junctional areas of the groin or axilla where tourniquets or other methods are not successful. It is the only injectable hemostatic device cleared for pre-hospital internal use.

Mini-sponges are inside the applicator. The mini-sponges are made of surgical grade cellulose-a material derived from plants.

Direct pressure is the most effective way to stop bleeding. XSTAT stops bleeding at the source of the injury. When XSTAT is inserted into the wound cavity and sponges are deposited, they expand up to 10x their original size when in contact with exudate or blood. The sponges fill the wound cavity and provides compressive forces inside to stop bleeding.

XSTAT sponges are not absorbable; they can be removed manually using basic forceps. Each mini-sponge has a radiopaque marker embedded on top. Under normal imaging, the sponges will show up as an “x” for clear visibility for removal.

  • Most hemorrhage control products are indicated for external use only. XSTAT is a one of a kind dressing that is designed for internal use.
  • XSTAT applies compression at the source of bleeding which stops bleeds more quickly.
  • XSTAT was designed to create pressure inside the wound to possibly alleviate the need for immediate manual external compression
  • XSTAT’s mini-sponges expand fully in 20 seconds resulting in faster hemostasis and significantly less total blood loss (Note: a transfusion can cost around $1,200/unit of blood).
  • Ease of use/intuitive – human factors testing has shown that XSTAT, in the hands of a trained clinician, can be quickly applied with minimal knowledge of the product.
  • Lightweight and compact- an applicator can be easily carried in a kit or bag.

No, there is no hemostatic agent in XSTAT. Recent studies have cautioned about the long-term use of hemostatic agents and the increased risk of embolus formation*.
*Otrocka-Domagala, et.al, Safety of the long term application of QuickClot Combat Gauze, ChitoGauze Pro and Celox Gauze, Polish Journal of Veterinary Sciences, Vol. 19, No.2 (2016), 337-343

Yes, a part of the XSTAT family is XSTAT-30 and XSTAT-12. The XSTAT-30 is 30mm in diameter while the XSTAT-12 is 12 inches in diameter.

XSTAT-30 is larger than the XSTAT-12 and was designed for large exit wounds. The XSTAT-12 is smaller in diameter and was designed for entrance wounds and other smaller penetrating trauma such as stab wounds and small caliber rounds.

In addition, the amount of sponges in the two applicators differ. The XSTAT-30 applicator has around 90 sponges while the XSTAT-12 has around 36 per applicator.

Under the Indications for Use, XSTAT could be used as a more effective solution than hemostatic dressings and junctional tourniquets in terms of time of application, potential total blood loss, and ease of use.

Benchtop testing has shown that XSTAT exerts approximately 10-15% above MAP (Mean Arterial Pressure); sufficient to stop bleeding but not to cause possible ischemia.