FDA Approves CPR Devices

FDA www.fda.gov has approved the ResQCPR System, a system of two devices for first responders to use while performing Cardiopulmonary Resuscitation (CPR) on people whose hearts stop beating. The two devices are intended to be used together to assist in performing CPR on adult patients with out-of-hospital non-traumatic cardiac arrest.

The first device, the ResQPump Active Compression Decompression CPR Device has a double-grip handle that attaches to the patient’s chest with a suction cup. This allows the rescuer to push to deliver compressions and lift for decompressions, which is different than what is currently used in standard CPR. It also includes a pressure gauge to help rescuers maintain recommended compression depth along with 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 place on the patient, it impedes airflow into the chest during chest decompression when using the ResQPump.

This reduces the pressure inside the patient’s chest and draws more blood back to the heart, a concept known as preloading. 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. The two devices used together may increase the amount of oxygenated blood circulated through a patient’s body during CPR.

FDA reviewed the data to approve the system that also included conducting a randomized clinical trial that compared the survival rates of 813 subjects who received standard CPR as opposed to 842 subjects who received CPR with the ResQCPR system. The clinical trial results showed that a larger number of subjects who received CPR with the ResQCPR system survived cardiac arrest.

Adverse events associated with the system were similar to those associated with standard CPR. However, pulmonary edema was more common in ResQCPR subjects than in standard CPR subjects.

The ResQCPR System is manufactured by Advance Circulatory Systems, Inc. www.advancedcirculatory.com a division of ZOLL Medical www.zoll.com.