The FDA has approved XSTAT (RevMedX), a novel device to control bleeding from certain types of wounds received in battle. This expandable, multi-sponge temporary wound dressing is for military use only, and is intended for areas that a tourniquet cannot be placed (eg, groin or armpit).
XSTAT contains 3 syringe-style applicators with 92 compressed, cellulose sponges that have an absorbent coating. A temporary physical barrier to blood flow is created as the sponges expand and swell to fill the cavity of the wound after about 20 seconds of contact with water from blood or bodily fluid. Up to 3 applicators may be used on a patient and each applicator has the capability to absorb approximately 300mL of fluid. The sponges must be removed before a wound is closed and cannot be absorbed by the body.
The FDA approval of XSTAT through the de novo classification process was based on animal studies that demonstrated its effectiveness at stopping bleeding and the absorption capacity of the device. Non-clinical biocompatibility data and testing of human factors were included in the submission for safety and usability support.
Each tablet-shaped sponge is 9.8mm in diameter and 4–5mm in height.
For more information call (888) 463-6332 or visit FDA.gov.