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FDA News Release

FDA approves CPR devices that may increase chance of surviving cardiac arrest

For Immediate Release

March 9, 2015

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The U.S. Food and Drug Administration 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 (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest.

The Centers for Disease Control and Prevention estimates that approximately 300,000 Americans experience an out-of-hospital cardiac arrest each year. CPR is an emergency procedure that can be life-saving for people in cardiac arrest. During this procedure, rescuers manually compress the patient’s chest and manually ventilate the lungs to keep blood oxygenated and circulating until the heart and breathing restart—or until the rescuers can apply advanced life-saving techniques, such as defibrillation. If provided immediately after cardiac arrest, this standard CPR procedure increases a patient’s chance of survival. 

The ResQCPR System consists of two devices that 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, allowing the rescuer to push to deliver compressions and lift for decompressions, which is different than standard CPR. It also includes 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 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. When used together, the two devices may increase the amount of oxygenated blood circulated through a patient’s body during CPR.

“Most people who suffer cardiac arrest outside of a hospital die,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the 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.”

The 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. 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 ResQCPR system were similar to those associated with standard CPR; however, pulmonary edema (the accumulation of fluid in the lungs) was more common in ResQCPR subjects than in standard CPR subjects.

The ResQCPR System is manufactured by Advance Circulatory Systems, Inc. in Roseville, Minnesota.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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Page Last Updated: 03/09/2015
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