RevMedx receives FDA clearance for XSTAT™, a first-in-kind hemostatic device for the treatment of gunshot wounds on the battlefield.
WILSONVILLE, Ore. (April 7, 2014) – RevMedx, Inc., announced today that the U.S. Food and Drug Administration (FDA) has cleared XSTAT™, a hemostatic device for the control of bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. XSTAT is a temporary device for use up to four hours until surgical care is acquired and is intended for use in the battlefield. The FDA reviewed XSTAT through its de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind.
"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."
Uncontrolled external hemorrhage is the leading cause of death on the battlefield. Bullets, knives or shrapnel can cause penetrating wounds in junctional areas—where the legs or arms meet the torso—that cannot be treated with a tourniquet or manual compression. The XSTAT device was designed to address this unmet need in combat medicine.
XSTAT works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. In a wound, the XSTAT sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood. This creates a temporary barrier to blood flow and provides hemostatic pressure. Each sponge contains an x-ray detectable marker to aid in surgical removal. 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 clearance 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.”
RevMedx plans to make the XSTAT available for battlefield use later this year. The development of XSTAT was supported by grants from the U.S. Special Operations Command and the U.S. Army Medical Research and Materiel Command’s Combat Casualty Care Research Program.
Based in Wilsonville, Ore., RevMedx is a privately-held medical device company that designs, develops, and manufactures lifesaving medical products. Working closely with Special Forces medics, RevMedx succeeded in developing XSTAT, a first-in-kind hemostatic device for the control of bleeding from junctional wounds on the battlefield. Find out more at www.revmedx.com.