FDA clears RevMedX wound dressing for civilian use

The FDA said today granted RevMedX’s XStat 30 wound dressing expanded 510(k) clearance to include adults and adolescents in the general population from an indiction of military use only.

The XStat 30 wound dressing is an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed, the agency said.

“When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available. It is exciting to see this technology transition to help civilian first responders control some severe, life-threatening bleeding while on the trauma scene,” FDA CDRH Office of Device Evaluation acting director Dr. William Maisel said in prepared remarks.

Wilsonville, Ore.-based RevMedX’s XStat 30 is cleared for patients at high risk of immediate, life-threatening and sever hemorrhagic shock and non-compressible junctional wounds in cases where definitive care at an emergency care facility cannot be achieved in a short period, the FDA said.

The dressing can be used for up to 4 hours, to allow the patient time to receive surgical care, the federal watchdog said.

The sponge-like wound closure device expands to fill wound cavities, creating temporary physical barriers to blood flow. Each applicator can absorb approximately a pint of blood.

The XStat 30 was cleared for battlefield use in April 2014.

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