Device addresses traumatic wounds in hard-to-treat places

SUBMITTED PHOTO: JOHN STEINBAUGH - Each XSTAT-30 is equipped with 92 sponges that expand to 10 times their compressed size to apply pressure to wounds.Marking a potentially lifesaving step in the struggle to make treatment of some life-threatening wounds easier, the U.S. Food and Drug Administration on Dec. 7 approved a product developed by a Wilsonville-based company to stop bleeding from traumatic injuries in places that are hard to treat by traditional methods.

The XSTAT 30 is a large syringe filled with 92 small, hyper-absorbent sponges. It is inserted into a wound and when the plunger is pressed, fills the injury with sponges that apply pressure to the wound as they expand. The sponges can be left in place for up to four hours.

Using the device in civilian settings allows first responders to better treat one of the biggest threats to victims of traumatic injuries.

“According to the United States Army Institute of Surgical Research, 30 to 40 percent of civilian deaths by traumatic injury are the result of hemorrhaging,” the FDA said in a statement. “Of those deaths, 33 to 56 percent occur before the patient reaches a hospital.”SUBMITTED PHOTO - Sponges used in the XSTAT-30 are marked with radiopaque dye, making them visible to x-ray machines.

The device was developed by RevMedx, a company created in 2009 by a grant from the United States Army. The Army wanted a company to develop a device to address “junctional hemorrhage,” or a wound to a place where a limb joins the body near a body cavity, like the groin, shoulder or lower abdomen. Those sorts of wounds often house major blood vessels, and are difficult to treat with a tourniquet.

“It’s been several years of laboratory testing, different types of laboratory testing ... until we really settled on the idea of sponges,” said Will Fox, vice president of sales and marketing for RevMedx.

Fox said that the initial idea for the product came after an employee visited Williams & Sonoma, and saw their “pop-up” sponges — flattened sponges that expand when they come into contact with water.

Sponges used in the XSTAT 30 are a bit different, however. Besides being sterile, each is fitted with radiopaque marking that makes them visible to x-ray machines. When they come into contact with liquid, they expand to 10 times their compressed size, and take on a macaroni-like shape that allows them to better apply pressure to a wound.

The XSTAT 30 was approved by the FDA for military use in April 2014, and began shipping to the Army in March 2015. It has met with a positive reception, Fox said.

Now that the FDA has approved the product for emergency responder use, civilians will benefit from its potential to treat injuries like gunshot wounds in hard-to-treat areas. RevMedx expects that the prescription-only device will

initially be deployed on am-bulances and with SWAT teams.

Fox said that the XSTAT 30 is a step toward a future in which access to emergency treatment for traumatic injuries is far more widespread than it is today. He points to the Department of Homeland Security’s “Stop the Bleed” initiative, which aims to make knowledge of basic wound treatment techniques — applying pressure and a tourniquet among them — commonplace.

Someday, however, the XSTAT 30 might be a part of every first aid kit.

“Where AEDs were 10 years ago — that’s really where we’re going with hemorrhage control access,” Fox said.

Contact Jake Bartman at 503-636-1281 ext. 113 or This email address is being protected from spambots. You need JavaScript enabled to view it..

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