FDA Approves CPR System

Made by Advanced Circulatory Systems Inc., a division of ZOLL Medical, the ResQCPR System consists of two devices that are used together to assist in performing CPR on adult patients with out-of-hospital, non-traumatic cardiac arrest.

The U.S. Food and Drug Administration announced March 9 that it has approved the ResQCPR System for first responders to use while performing cardiopulmonary resuscitation on people whose hearts have stopped beating, with FDA stating that using the system during these emergencies can improve patients' chance of surviving cardiac arrest.

Made by Advanced Circulatory Systems Inc., a division of ZOLL Medical, the ResQCPR System consists of two devices that are used together to assist in performing CPR on adult patients with out-of-hospital, non-traumatic cardiac arrest. The first device is the ResQPump Active Compression Decompression CPR Device, which has a double-grip handle that attaches to the patient's chest with a suction cup, allowing the rescuer to push to deliver compressions and lift for decompressions. It has a pressure gauge to help rescuers maintain recommended compression depth and a timing mechanism to help the rescuer maintain the necessary compression rate. The second device, the ResQPod 16.0 Impedance Threshold Device, fits onto a rescue face mask or breathing tube. When placed on the patient, it impedes airflow into the chest during chest decompression with the ResQPump, reducing the pressure inside the patient's chest and drawing more blood back to the heart. "A greater volume of blood being drawn into the heart can mean a greater volume of blood flowing out of the heart during the next compression which may improve overall blood circulation as compared to standard CPR. When used together, the two devices may increase the amount of oxygenated blood circulated through a patient's body during CPR," according to FDA.

"Most people who suffer cardiac arrest outside of a hospital die," said Dr. William Maisel, MD, MPH, acting director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health. "The ResQCPR System may increase oxygenated blood circulation during CPR, which in turn may improve the likelihood of survival in adult patients with out-of-hospital, non-traumatic cardiac arrest."

FDA reviewed data supporting the approval of the ResQCPR System, including a randomized clinical trial that compared survival rates of 813 subjects who received standard CPR to 842 subjects who received CPR with the ResQCPR System. More subjects who received CPR with the ResQCPR System survived cardiac arrest, FDA reported.

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