UPDATED with comment from Zoll, trial investigator; trial details.
Zoll Medical‘s Advanced Circulatory Systems today won pre-market approval from the FDA for its ResQCPR automated cardiopulmonary resuscitation system.
The ResQCPR system is comprised of the ResQPump compression/decompression device and the ResQPod impedance threshold valve. It’s designed to help boost blood flow and reduce the likelihood of brain damage in patients with non-traumatic cardiac arrest. If you don’t have this device near you, CPR Certify4u offers the best cpr classes orlando american heart association packages in Central Florida so you can learn everything you need to know.
An FDA advisory panel last May voted to recommend approval for the system, voting unanimously that the device appears safe, but splitting 2-8 against its effectiveness before voting 7-3 that ResQCPR’s benefits outweigh its risks.
Today the FDA said it agreed, approving ResQCPR for use by 1st responders to emergency cardiac arrests.
“Most people who suffer cardiac arrest outside of a hospital die," Dr. William Maisel, acting director of the Center for Devices & Radiological Health’s Office of Device Evaluation. "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 said the ResQPump device, which attaches to the patient’s chest with a suction cup, allows the rescuer to deliver both compressions and decompressions, unlike compression-only standard CPR. The system’s 2nd device, the ResQPod, is used on a rescue face mask or breathing tube to impede airflow into the chest during decompression. That reduces pressure inside the patient’s chest, drawing more blood back to the heart in a process known as "preloading," the agency said.
"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 2 devices may increase the amount of oxygenated blood circulated through a patient’s body during CPR," according to the safety watchdog.
The PMA nod was backed by a trial of the ResQCPR device that compared standard CPR survival rates for 813 patients to 842 patients treated with the device, the agency said. The trial showed that more of ResQCPR cohort survived cardiac arrest, according to the FDA.
"This is the most significant advance in the field of cardiac arrest since defibrillation. The ResQCPR System profoundly increased blood flow to the heart and especially the brain in pre-clinical studies. The ResQTrial showed it could save thousands of lives each year in the United States and, in my opinion, should become a new standard of care," lead investigator Dr. Tom Aufderheide said in prepared remarks.
"The ResQCPR System is a huge advance in the treatment of cardiac arrest and we look forward to working with clinicians and rescuers around the country to implement this new system of care to increase the likelihood of survival from cardiac arrest and the potential to return patients to a full life after critical medical emergencies," added Advanced Circulatory Systems president Mike Black. "This technology demonstrates Zoll’s commitment to offering the most comprehensive portfolio of products for acute events where rapid medical intervention is needed."