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| How the Xstat 30 wound dressing works--Courtesy of RevMedX |
Startup RevMedX has won FDA clearance for its Xstat 30 wound dressing. It's a syringe-like device that fits into gunshot and shrapnel wounds; it 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.
The Xstat 30 device was already approved for military use by the FDA in April 2014. Its indication extension into the U.S. civilian population comes just as gun violence has gained a global spotlight in the wake of a series of high-profile attacks. Some suggest that the rate of U.S. gun deaths has been mitigated, in part, by improvements in trauma care in recent decades.
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," Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement. "It is exciting to see this technology transition to help civilian first responders control some severe, lifethreatening bleeding while on the trauma scene."
The FDA specifically cleared Xstat 30 for use 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. 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.
The device will be marketed in packages of one or three syringelike applicators that each contain 92 compressed minicellulose sponges with an absorbent coating. These expand and swell to fill the wound cavity temporarily. The number of sponges necessary depends on the size and depth of the wound; each applicator can absorb about a pint of blood and up to three applicators can be used on a given patient.
- here is the FDA announcement