RevMedx receives CE Mark for XSTAT® injectable hemostatic devices

Revolutionary bleeding control technology will now be available in Europe and other International markets.

RevMedx, Inc., a leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XSTAT 30 and XSTAT 12 hemostatic devices in Europe. Unlike traditional wound treatments that may take several minutes to be effective, XSTAT can stop bleeding in seconds to stabilize injuries until patients reach an emergency facility.

XSTAT devices work by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. In a wound, the sponges rapidly expand and exert hemostatic pressure. Since its receiving initial FDA-clearance in the United States in 2014, there have been numerous successful uses of XSTAT devices in civilian and military pre-hospital settings.

Andrew Barofsky, President and CEO of RevMedx, Inc., stated, “CE Mark opens the opportunity for RevMedx to get our devices in the hands of emergency responders and surgeons in the European Union and around the world. This certification clearly indicates that the XSTAT devices and our supporting quality system met the essential requirements for product safety, performance and usability, in compliance with rigorous requirements set by the EU’s Medical Device Directive (MDD).”

For victims of violence or accidents, early control of severe bleeding may prevent shock and may be life-saving. The United States Army Institute of Surgical Research reports that 30 to 40 percent of civilian deaths by traumatic injury are the result of hemorrhaging; of those deaths, 33 to 56 percent occur before the patient reaches an emergency care facility.