EleGARD System Released for Human Use; Selected Agencies to Start Deploying April 1
[March 15, 2019: Minneapolis, MN] The EleGARD™ Patient Positioning System by AdvancedCPR Solutions™ has been released for human use. The device will be placed in selected evaluation sites by April 1, and the company expects its first human use will occur shortly thereafter.
In keeping with general controls required to market a Class 1 device, AdvancedCPR Solutions’ quality system and product development process were evaluated for this release of the EleGARD System for human use, and the device has been Listed with the US FDA as a Class 1 device. With this Release and Listing, the EleGARD Patient Positioning System is now available for use by medical professionals.
The EleGARD delivers rapid, secure and safe ElevatedCPRTM therapy patient positioning in the pre-hospital and hospital setting.
ElevatedCPR therapy is a broad, patent-protected, technologically-advanced method of performing device-assisted head up CPR that could potentially improve survival from cardiac arrest. ElevatedCPR therapy incorporates lifting the head, heart, and thorax in a multi-angled incline, in a timed sequence, in conjunction with the best practice standards of resuscitation protocols. Preclinical evidence shows a number of benefits associated with this therapy relative to intracranial pressure (ICP), cerebral perfusion pressure (CerPP) and coronary perfusion pressure (CorPP).
Founded in Minneapolis, Minnesota in 2015 by an experienced team that previously developed multiple novel resuscitation technologies currently in widespread clinical practice, AdvancedCPR Solutions (formerly Minnesota Resuscitation Solutions) is an early stage medical device firm focused on the development and commercialization of ElevatedCPR therapy delivery mechanisms, methods and devices to potentially improve survival of cardiac arrest.