XStat: FDA Approved Syringe Filled with Expandable Sponges to Treat Gunshot Wounds in Seconds

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XStat Syringe

Being able to stop a gunshot or shrapnel wound from bleeding out could help save lives in a war zone.

While tourniquets are useful for injuries to extremities, wounds in the pelvis or shoulder require a different approach. Currently, you have to stuf gauze into the wound. Not only is gauze not FDA cleared for this type of application, it’s often very painful, imprecise, and ineffective, requiring field medics to repeat the agonizing process.

The U.S. military asked a medical technology company to come up with a better solution. The working idea was a medical version of Fix-a-Flat, the foam you squirt in punctured tires to plug up a hole.

“One of the co-founders of the company, Dr. Ken Gregory, was shopping at a Williams-Sonoma and discovered this kitchen sponge that was dried and compressed. You’d bring it home, splash water under it, and it would pop up into a normal-sized kitchen sponge,” Andrew Barofsky, RevMedx’s CEO tells CNN. “That was kind of a lightbulb moment.”

That’s when XSTAT™ was invented.

“XStat™ is a novel device that can be rapidly deployed, providing fast-acting hemorrhage control to stabilize a wounded patient for transport,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This will be an important new treatment option for our nation’s military to treat injured soldiers who may not be in close proximity to a medical facility.”

XStat received FDA approval in April, and RevMedx is now ready to get it into the hands of medics, says Barofsky. He expects to provide a limited quantity of XStats to the U.S. military in 2014, with the hopes of expanding the market to other clients, such as paramedics and law enforcement officers in the future.

Removing the pellets from the injured is the current problem in it’s design. Forceps are used to pull out each sponge, though RevMedx is working on biodegradable designs that could be left in the body, or adding a string to the sponges so they could be pulled out like a string of beads. Until those developments make it to market, blue, radiopaque threads are sewn into the sponges, allowing any strays stuck in the wound to be identified with x-rays and removed.

XSTAT 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.

“We are pleased to receive approval for the XSTAT device, which brings a new capability to military medics for treating a major cause of preventable combat death,” said Andrew Barofsky, CEO of RevMedx. “We are committed to offering new solutions for the unmet needs of military first responders and their patients.”

Tool can plug gunshot wounds in seconds

Syringe filled with tiny sponges fills up wound, applies compression in seconds.

XStat heals bullet wounds in seconds

A new hemostatic dressing that can seal a bullet wound within seconds of its application is under development by RevMedx in Portland. Called ‘XStat’, the treatment involves the use of a lightweight applicator to deliver small compressed sponges into a wound in the pelvis or shoulder. The sponges then expand to stem blood flow and exert pressure on the wound.

New Sponge-Filled Syringe Seals Up Bullet Wounds in 15 Seconds

The Xstat syringe pushes a number of tiny sponges into a wound, stopping blood loss and applying needed pressure, all in just 15 seconds.

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