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It’s been approved for a year and a half on the battlefield and now a new device is approved for use in civilian ERs, too. The Food and Drug Administration has approved wider use of the XSTAT 30 wound dressing.
The syringe-shaped device shoots little sponges into the wound. They expand to fill the space and stop the bleeding for up to four hours – until a surgeon can get to work.
Between 30 and 40 percent of trauma deaths are caused by bleeding, the Army Institute of Surgical Research, says. “Of those deaths, 33 to 56 percent occur before the patient reaches a hospital,” the FDA said.
It’s worse in battle. The Army Combat Casualty Care Research Program says 86 percent of all military personnel killed in battle die within 30 minutes of being wounded. Nearly half of all battlefield deaths since World War Two have been from bleeding.
“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 the FDA’s Dr. William Maisel.
“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 device is shaped so that it can be used where a tourniquet or large dressing would be useless –for instance, in the groin or armpit. “XSTAT 30 is not indicated for use in certain parts of the chest, abdomen, pelvis or tissue above the collarbone,” the FDA said.
Manufacturer RevMedX, Inc. of Wilsonville, Oregon says the compressed sponges inside expand to as much as 10 times their size as they soak up blood.
“The majority of people with massive abdominal bleeding die before they reach the hospital."
A spokesman for the company says there's no information on whether the device has been used, and so it's impossible to say whether it has saved any lives.
"RevMedx delivered our first of several shipments of XSTAT to U.S. Special Forces in March of this year. We have heard that XSTAT has been fielded by Special Forces units but have no confirmed uses on patients at this time," he said.
Each mini-sponge carries a little marker that makes it show up on an x-ray, so any left behind during emergency surgery can be found and removed.
RevMedX specializes in battlefield wound devices. It’s also working on a wound dressing embedded with little sponges.
Other companies are working on similar products. Also this month, Arsenal Medical of Massachusetts said it won a $14 million contract from the U.S. Army to develop ResQFoam, a different material designed to be stuffed into big wounds and hold off the bleeding for long enough to get the patient into surgery.
“The majority of people with massive abdominal bleeding die before they reach the hospital,” Dr. David King, a trauma surgeon at Massachusetts General Hospital, said in a statement released by the company.
“Many of these deaths could be prevented if we were able to temporarily stabilize a patient long enough to reach a trauma center.”