CHELMSFORD, Mass. — The ZOLL® ResQCPR™ System has been granted premarket approval by the U.S. Food and Drug Administration (FDA) to market and begin U.S. distribution of the CPR adjunct system.
A study evaluating the ResQCPR System, known as the ResQTRIAL, which the FDA considered in its approval process, demonstrated a 49 percent increase in survival to one year in adult patients who experienced out-of-hospital cardiac arrest of presumed cardiac etiology, as compared to treatment with conventional manual CPR.
The ResQCPR System uses Intrathoracic Pressure Regulation (IPR), a proprietary, non-invasive therapy developed by Advanced Circulatory Systems, Inc. of Roseville, Minn., which ZOLL acquired in January 2015. IPR technology uses the body’s own mechanisms to enhance circulation without the use of pharmaceutical or other agents.
The ResQCPR System is comprised of the ResQPOD® Impedance Threshold Device and the ResQPUMP® Active Compression-Decompression CPR Device, which work synergistically to improve perfusion.
The ResQCPR System is expected to be commercially available to rescuers in mid-2015.