Home Reviews FDA Approves Device to Heal Gunshot Wounds in Battlefields

FDA Approves Device to Heal Gunshot Wounds in Battlefields

by Stella Kabura
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As terrorist attacks become rampant in countries like Nigeria and Kenya, the FDA has recently approved the use of the XStat, a unique homeostatic device for the treatment of gunshot and shrapnel wounds on battlefields or war-torn areas, that could save lives in 20 seconds.

“XStat™ is a novel device that can be rapidly deployed, providing fast-acting hemorrhage control to stabilize a wounded patient for transport,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health.

The device came about after the U.S. military had requested RevMedx, a medical technology company to develop a way to stop gunshot and shrapnel wounds from excessive bleeding. According to Foreman, the device would serve as a new treatment option for military to treat wounded soldiers who may not be in close proximity to a medical facility. Perhaps, in future tragic events such as that of the Westgate Mall attack that killed more than 60 individuals, injuring over 200 in Nairobi, Kenya, this device may in the near future reduce the impact of injury on victims.

In recent months, Somalia’s al-Qaeda linked al-Shabaab has been blamed for bomb attacks in various parts of Kenya such as Nairobi, Garisa and Mombasa, with victims left in critical condition. Moreover, the outlawed group in May vowed to move their war to Kenya, in a broadcast by a top commander urging fighters to rise up against Nairobi, thus instilling fear amongst citizens.

Yet, in events such as bombings or battles, the standard method of plugging wounds includes packing them with bandages and tampons and then applying direct pressure for several minutes, of which, can take several minutes too long, experts say. In fact, bleeding out in victims is a major cause of fatalities.

Nevertheless, the device works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. Each sponge contains an x-ray detectable marker. In the wound, the XSTat sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood of which, creates a temporary barrier to blood flow while provides hemostatic pressure.

Indications for the use of XStat™ intended for use in the battlefield include the control of bleeding from junction wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents, while also acting as a temporary device for use up to four hours until surgical care is acquired, note innovators. However, it is not indicated for use in the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.

However, amidst terror attacks, ​XStat-30™ is currently in pre-production and will be available for battlefield use later this year 2014.

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