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FDA Approves Zoll CPR System

March 9, 2015

The FDA on Monday announced approval of a dual-device system for first-responders that could improve survival rates for people suffering heart attacks. 

The ResQCPR System is comprised of the ResQPump Active Compression Decompression CPR device and ResQPod 16.0 Impedance Threshold Devices. The ResQPump has a double-grip handle that attaches to the patient’s chest with a suction cup and compresses the chest when the rescuer pushes it. The pump includes a pressure gauge to help first-responders maintain recommended compression depth and a timing mechanism by which to pace the compressions.

The ResQPod fits onto a face mask or breathing tube to block airflow into the chest when the chest is decompressing, reducing pressure inside the patient’s chest. The technique also increases blood flow to the heart, which tends to improve overall blood circulation, the FDA said.

Clinical studies compared outcomes of 813 subjects who received standard CPR with those of 842 subjects who got CPR via the ResQCPR System. Subjects treated with ResQCPR showed a higher survival rate, the agency said.

ResQCPR was developed by Advance Circulatory Systems, which was purchased by Zoll Medical in December 2014.  An FDA advisory panel unanimously recommended approval of the system last May. — Elizabeth Orr