FDA approves new CPR devices

The FDA announced that it has approved a cardiopulmonary resuscitation system for use in adults with out-of-hospital, nontraumatic cardiac arrest.

The system (ResQCPR, Advance Circulatory Systems Inc.) consists of two devices to be used together by first responders. The first device (ResQPump Active Compression Decompression CPR Device) has a double-grip handle that attaches to the patient’s chest with a suction cup, enabling the rescuer to push for compressions and lift for decompressions. The device also includes a pressure gauge and timing mechanism to help maintain the necessary compression depth and rate, respectively, according to a press release from the FDA.

The second device (ResQPod 16.0 Impedance Threshold Device), which fits onto a face mask or breathing tube, impedes airflow into the chest during decompression, which reduces chest pressure and draws a greater volume of blood into the heart. This can result in a greater volume of blood flowing back to the heart during the next compression, potentially improving overall blood circulation compared with traditional CPR, according to the release.

William Maisel

The approval was based on results from a randomized trial of 842 patients who received CPR with the system and 813 who received standard CPR. Those who received CPR with the system had a higher survival rate. Adverse events were similar between the two groups; however, pulmonary edema occurred more frequently among those treated with the system, according to the release.

“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 the release. “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, nontraumatic cardiac arrest.”