FDA Approves Device That Can Plug Gunshot Wounds in 15 Seconds
The U.S. Food and Drug Administration has given clearance to startup RevMedX to introduce its XStat Rapid Hemostasis System (XStat 30) – an innovative sponge-filled gunshot wound dressing device – for civilian use. The device received FDA clearance in April 2014 to be used on the battlefield, but now ambulances in the U.S. will have the option of carrying XStat 30 as well. The device can plug a gunshot wound in just 15 seconds.
XStat 30 will be marketed in packages of one or three syringelike applicators that each contain 92 compressed minicellulose sponges with an absorbent coating. The device which is syringe-like fits into gunshot and shrapnel wounds and injects a large number of tiny, rapidly expanding sponges into the wound cavity. It’s designed to quickly control bleeding for injuries where tourniquets are not an option, such as the groin or armpit, and is intended for up to four hours of use until surgery. Each applicator absorbs about a pint of blood, and up to three applicators can be used on a patient. Further, each tablet contains a radioplaque marker that can be spotted under an X-ray to help with extraction.
Originally developed for the military, the FDA says first responders can now use XStat 30 to treat adolescents and adults in the civilian population who are facing life-threatening and severe hemorrhagic shock.
It is very important to control severe bleeding very early. XStat 30 could help to further that trend once it’s in civilian use. About 30% to 40% of traumatic injury deaths of U.S. civilians are a result of hemorrhaging, according to the United States Army Institute of Surgical Research. Of these, 33% to 56% occurred before the patient reached the hospital.
“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 Dr. William Maisel in a FDA release. “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 FDA has specifically cleared that XStat 30 should be used only in patients at high risk for immediate, life-threatening and severe hemorrhagic shock and noncompressible junctional wounds, when definitive care at an emergency care facility cannot be reached within minutes, and not to be used in certain parts of the chest, abdomen, pelvis, or tissue above the collarbone.
About 33,000 people are killed by the guns in the United States annually, of which some 20,000 are suicides and 11,000 are homicides. The United States this yes alone has experiences 462 mass shootings. So, the announcement of XStat 30’s approval comes at a time when they seem to be needed the most.