The US Food and Drug Administration (FDA) has granted premarket approval (PMA) for Zoll Medical‘s ResQCPR system to market and begin distribution of the cardiopulmonary (CPR) adjunct system in the US.
Designed to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest, the system is expected to be commercially available in mid-2015.
ResQCPR system was evaluated in a pivotal study called ResQTRIAL, which showed a 49% increase in survival to one year in adult patients who experienced out-of-hospital cardiac arrest of presumed cardiac etiology, compared to treatment with conventional manual CPR.
The company said that if widely implemented, the new system could save thousands of lives each year in the US from out-of-hospital cardiac arrest alone, based on study results.
ResQTRIAL lead investigator Tom Aufderheide said: "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 United States and, in my opinion, should become a new standard of care."
In January, the company acquired Advanced Circulatory Systems and its non-invasive therapy Intrathoracic Pressure Regulation (IPR)is being used in the ResQCPR system.
This technology uses the body’s own mechanisms to improve circulation without the use of pharmaceuticals or other agents.
The system features the ResQPOD Impedance Threshold Device and the ResQPUMP Active Compression-Decompression CPR Device, which work synergistically to improve perfusion.
Advanced Circulatory Systems president Mike Black said: "The ResQCPR system is a huge advance in the treatment of cardiac arrest and we look forward to working with clinicians and rescuers around the country to implement this new system of care to increase the likelihood of survival from cardiac arrest and the potential to return patients to a full life after critical medical emergencies."
ZOLL develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies.