Sponge-Filled Syringe to Treat Gunshot Wounds Approved for Military Use

The FDA has approved a first-of-a-kind hemostatic dressing to control bleeding from battlefield wounds in the pre-hospital setting. The XStat™, manufactured by RevMedx, Inc., of Wilsonville, Oregon, is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as in the pelvis/groin or shoulder/armpit regions. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care.

Necessity

According to the U.S. Army Medical Department, Medical Research and Materiel Command, since mid-World War II, nearly 50 percent of combat deaths have been due to bleeding out. Of those, half could likely have been saved if timely, appropriate care had been available. At the present time, military field medics have to pack layers of gauze into a wound to stop the bleeding, a time-consuming process that does not always work. Moreover, medics are taught that if the bleeding does not stop within three minutes, to go through the extremely painful process of pulling out the gauze and starting the process again.

The Device

According to the FDA, the XStat consists of three, syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating. RevMedx’s XStat syringe injects these hemostatic sponges into deep wounds. After approximately 20 seconds of contact with water from blood or bodily fluid, the sponges expand to fill the wound cavity, creating a temporary physical barrier to blood flow. No direct manual pressure is required. The number of sponges needed for effective hemorrhage control will vary depending on the size and depth of the wound. Up to three applicators may be used on a patient.

The Sponges

The tablet-shaped sponges are each 9.8 millimeters in diameter and 4 to 5 millimeters in height. They can absorb 3 milliliters of blood or body fluid. An applicator filled with 92 sponges can absorb about 300 milliliters of fluid.The sponges cannot be absorbed by the body and all sponges must be removed from the body before a wound is closed. For ease of visualization and to confirm removal of every sponge, each sponge contains a marker visible via X-ray.

FDA Review

The FDA reviewed XStat through its de novo classification process, a regulatory pathway for novel, low- to moderate-risk medical devices that are first-of-a-kind. In a preclinical model with aggressive non-compressible hemorrhaging, Xstat provided statistically significant improvement in hemostasis and survival 60 minutes after injury with a large reduction in blood loss, resuscitation fluid requirement, and medic treatment time compared to conventional hemorrhage control dressings.

The FDA’s review of XStat included animal studies demonstrating its effectiveness at stopping bleeding and the absorption capacity of the device. Non-clinical biocompatibility data and human factors testing were also provided to demonstrate the safety and usability of the device.

Interview with Co-Developers

On March 5, 2014, RevMedx’s Chief Executive Officer, Andrew Barofsky, and Director of Strategic Development, John Steinbaugh (a former special forces medic), appeared on Fox Business Channel’s Opening Bell and explained how their device can be used both on the battlefield to seal wounds and in civilian application by first responders.