FDA approves XSTAT-30 bullet wound plugging device

Posted on 9 Dec 2015 by Michael Cruickshank

The US Food and Drug Administration (FDA) has this week approved an innovative device used to treat bullet wounds for civilian use.

The XSTAT-30 is a small syringe-like device which is used to rapidly stop bleeding from open bullet wounds.

Manufactured by biotech company RevMedX, the device works by inserting a large number of small, tablet-shaped sponges into a bullet wound.

These sponges expand on contact with blood, effectively acting as a tourniquet, allowing blood to clot and thus preventing the patient from bleeding out.

Previously restricted to use by the military, the device was cleared for use in civilian adults and adolescents suffering from “severe, life-threatening bleeding from wounds”.

“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,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

“It is exciting to see this technology transition to help civilian first responders control some severe, life-threatening bleeding while on the trauma scene.”

The XSTAT-30, also known as the XSTAT Rapid Homeostasis System, is intended to be used on regions of the body where traditional tourniquets are difficult or impossible to use. This includes regions like the shoulders and groin.

When inserted into a wound the small sponges are able to absorb up to 1 pint (473ml) of blood. Each XSTAT-30 lasts around 4 hours, and can reportedly be applied up to three times to a wound site.

Due to the small size of the individual sponges and the risk of them being left inside the body of the patient, each contains a ‘radioplaque’ marker that enables it to be spotted under an X-ray.

Given that a significant portion of the number of deaths caused by bullet wounds are the result of patients bleeding out, such a device has the potential to save many lives.

Furthermore, the approval of this device comes at a time of heightened awareness of gun violence in the US.

The country has been plagued by a large number of mass shootings over the past year, on top of the 12,571 killed in gun violence in 2014.

With firearm controls still politically difficult in the US, innovative devices such as the XSTAT-30 could provide a stop-gap solution on the path to reducing this death toll.