FDA approves two-device CPR system

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The FDA gave a green light to a dual-device cardiopulmonary resuscitation (CPR) system designed to maximize the compression-decompression process and improve blood circulation to the heart and other organs.

In May 2014, the FDA’s Circulatory System Devices Advisory panel recommended approval of the system for first responders who perform CPR in people with nontraumatic, out-of-hospital cardiac arrest. The system includes the ResQPump, which allows rescuers to compress and decompress the patient’s chest and a pressure gauge to monitor compression depth and timing. The second device, the ResQPod, is placed on a rescue face mask or into a breathing tube to impede airflow during chest decompression. The preloading process helps draw more oxygenated blood to the heart during CPR.

“Most people who suffer cardiac arrest outside of a hospital die,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a release. “The ResQCPR System may increase oxygenated blood circulation during CPR, which in turn may improve the likelihood of survival.”

The FDA based its decision on clinical trial data that compared the ResQCPR System to standard CPR. Results showed the ResQCPR was more effective than standard CPR with similar adverse event rate, although more patients in the ResQCPR experienced pulmonary edema.

Advance Circulatory System manufactures the ResQCPR System. In late 2014, the Roseville, Minn.-based company announced that it was being acquired by Zoll Medical of Chelmsford, Mass. It is now a division of Zoll.