AdvancedCPR Solutions Completes Requirements Necessary for CE Marking For EleGARD™ Patient Positioning System
[July 30, 2019: Minneapolis, MN] AdvancedCPR Solutions has completed the requirements to apply the CE Mark for its EleGARD Patient Positioning System. The CE marking confirms that the EleGARD System meets the requirements of the European Medical Devices Directive, which now allows AdvancedCPR Solutions to begin clinical use, and to commercialize the EleGARD System in the European Union and other CE Mark geographies.
“As we move into the marketplace, this CE Marking will enable us to work with several European clinical sites to deploy the EleGARD System, and begin work with sales and distribution partners who have expressed interest in launching the device in their geographic markets,” commented AdvancedCPR Solutions’ CEO Phil Faris.
Founded in Minneapolis, Minnesota in 2015 by an experienced team that previously developed multiple novel resuscitation technologies currently in widespread clinical practice, AdvancedCPR Solutions is an early stage medical device firm focused on the development and commercialization of delivery mechanisms, methods and devices that enable the ElevatedCPRTM method to potentially improve survival of cardiac arrest. The ElevatedCPR method is a broad, patent-protected and technologically-advanced technique for performing device-assisted head up CPR that incorporates raising the head, heart, and thorax in a multi-level elevation, in a timed sequence, in conjunction with the best practice standards of resuscitation protocols. Preclinical studies have demonstrated a number of benefits associated with the ElevatedCPR method relative to intracranial pressure (ICP)1 2 3, cerebral perfusion pressure (CerPP)1 2 3 4 5 6 7 and coronary perfusion pressure (CorPP) )2 3 4 5 6 7. The company’s initial device, the EleGARD Patient Positioning System, precisely, rapidly, and consistently positions patients for airway management and CPR, and supports positioning for the delivery of the ElevatedCPR method in the pre-hospital and hospital settings.