A pocket-size device Xstat that has been used only on the battlefield to stop bleeding caused by gunshots has now been approved by the US Food and Drug Administration for civilian use at a wider range.
The syringe-like device called, Xstat is a life-saving invention, a first of its kind, has the ability to save many lives.
Xstat shoots tiny sponges into the wound and then they expand sealing the bleeding for up to four hours until a surgeon attends the wound. The device was developed by an Oregon startup RevMedx.
The syringe-like the device is ready loaded with 92 small sponges made from wood pulp and coated with chitosan, an antimicrobial solvent that boosts blood clotting. Also, these anti-bacterial sponges won’t dissolve into the body, which can be identified easily and removed from the body as they carry markers on them that show up on an X-ray to make sure that nothing gets stuck in the body.
In the US, up to 40% of trauma deaths are due to bleed, the Army Institute of Surgical Research, says. Of those deaths, 33 to 56 percent occur before a patient even reaches a hospital, the FDA said.
The case is even worse in the battle. The Army Combat Casualty Care Research Program says about 86 percent of military personnel killed on the battlefield die within 30 minutes of being wounded.
“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,” William Maisel, director of the FDA’s Office of Device Evaluation said. “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,” 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.”
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