Chelmsford, Mass.— ZOLL® Medical Corporation, a manufacturer of medical devices and related software solutions, today announced that the company’s ResQCPR™ System has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) to market and begin U.S. 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 pivotal 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. If widely implemented, the ResQCPR System could save thousands of lives each year in the U.S. from out-of-hospital cardiac arrest alone, based on these study results.
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. This innovative 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, M.D., M.S., FACEP, FACC, FAHA, 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 United States and, in my opinion, should become a new standard of care.”
“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,” said Mike Black, President, Advanced Circulatory Systems. “This technology demonstrates ZOLL’s commitment to offering the most comprehensive portfolio of products for acute events where rapid medical intervention is needed.”
About ZOLL Medical Corporation
ZOLL Medical Corporation, an Asahi Kasei Group company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com.
About Asahi Kasei
The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the chemicals and fibers, homes and construction materials, electronics, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals, diagnostic reagents, and nutritional products. With more than 29,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.