FDA approves XSTAT 30 wound dressing from RevMedX

The FDA has cleared the use of the XSTAT 30 wound dressing from RevMedX, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication from use by the military only to use in adults and adolescents in the general population. The FDA cleared XSTAT 30 through the 510(k) review process after the manufacturer demonstrated the product was substantially equivalent to the XSTAT, which was granted marketing authorization for battlefield use in April 2014.

Comment: The dressing can be used for up to four hours, which could allow time for the patient to receive surgical care. The device is available in packages of one or three syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating. The sponges expand and swell to fill the wound cavity, creating a temporary physical barrier to blood flow. The number of sponges needed for effective haemorrhage control will vary, depending on the size and depth of the wound. Each applicator can absorb about a pint of blood, and up to three applicators may be used on a patient.