Zoll ResQCPR system receives premarket approval from the FDA

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Zoll’s ResQCPR system has been granted premarket approval by the US Food and Drug Administration (FDA) to market and begin US distribution of the CPR adjunct system.

The technology, which has been shown to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest, is expected to be commercially available in mid-2015.

A study evaluating the ResQCPR system, known as the ResQTRIAL, which the FDA considered in its approval process, demonstrated a 49% 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. A Zoll press release says that if widely implemented, the ResQCPR system could save thousands of lives each year in the US from out-of-hospital cardiac arrest alone, based on these study results.

The ResQCPR System uses intrathoracic pressure regulation, a proprietary, non-invasive therapy developed by Advanced Circulatory Systems, which Zoll acquired in January 2015. This 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.

Lead investigator for the ResQTRIAL, Tom Aufderheide, commented, “This is the most significant advance in the field of cardiac arrest since defibrillation. The ResQCPR system profoundly increased blood flow to the heart and especially the brain in pre-clinical studies. The ResQTRIAL showed it could save thousands of lives each year in the USA and, in my opinion, should become a new standard of care.”

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