The FDA today approved a CPR device that the agency claims may improve a patient's chances of surviving cardiac arrest.
The FDA today approved a cardiopulmonary resuscitation (CPR) device that the agency claims may improve a patient’s chances of surviving cardiac arrest.
Manufactured by Advance Circulatory Systems, the ResQCPR System is comprised of 2 devices designed to be used together to increase a patient’s oxygenated blood circulation during CPR.
The first device, the ResQPump Active Compression Decompression CPR Device, suctions to a patient's chest and allows a first responder to deliver compressions, aided by a pressure gauge and a timing mechanism.
The second device, the ResQPod 16.0 Impedance Threshold Device, is fitted onto a rescue face mask or breathing tube placed onto the patient, where it impedes airflow into the chest during chest decompression. This reduces the pressure inside the chest and draws more blood back to the heart.
The FDA based its nod on clinical data from a number of studies evaluating the efficacy and safety of the ResQCPR System, including a randomized trial in which a greater number of patients who received CPR with the system survived cardiac arrest than those who were treated with standard CPR.
“Most people who suffer cardiac arrest outside of a hospital die,” said William Maisel, MD, MPH, acting director of the FDA’s Office of Device Evaluation, in a press 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, non-traumatic cardiac arrest.”
Adverse events experienced by patients treated with the ResQCPR System were comparable to those associated with standard CPR, though the FDA noted that pulmonary edema occurred more frequently in ResQCPR subjects than in standard CPR recipients.
Approximately 300,000 Americans experience an out-of-hospital cardiac arrest each year, according to estimates from the US Centers for Disease Control and Prevention.