A Medical Device Daily
A lightweight, pre-mixed, dressing compound proven to stem high-pressure bleeding in moderate-to-severe wounds has received FDA clearance after six weeks of review. WoundStat, available for both soldiers and civilians, is easy to carry and can be applied on the spot, according to its manufacturer, TraumaCure (Bethesda, Maryland).
"The FDA's speedy approval of WoundStat means that we can get it more quickly into the hands of those who need it most today - our warfighters in harm's way around the world." said Devinder Bawa, CEO of TraumaCure. "The product's effectiveness is particularly important with core body wounds that a tourniquet can't reach. We believe that WoundStat has the potential to provide the military with another important tool to minimize battlefield deaths caused by hemorrhaging."
The company said that a study in the Journal of Trauma showed that WoundStat stopped potentially deadly arterial hemorrhaging in three minutes, and continued to do so for at least two hours. The study was conducted by a multidisciplinary team of researchers at the Reanimation Engineering Shock Center of Virginia Commonwealth University (VCURES; ).
The technology behind WoundStat is the result of more than three years of R&D work by VCURES. The university conducts research on life-saving technologies, and plays a key role in training Special Operation Combat Medics in the U.S. military.
TraumaCure makes wound treatment used to treat traumatic injury, for surgical procedures, or similar needs.