Minnesota medical device maker Advanced Circulatory Systems won a panel date with the FDA to review a PMA bid for its ResQCPR resuscitation systems.
The FDA’s Circulatory System Devices Panel will convene May 6, 2014, to discuss and vote on information related to the ResQCPR device, a manual CPR assistance system. The technology helps to restore blood flow to the heart and vital organs to improve a patient’s chance of survival and lessen the risk of brain damage following a cardiac arrest.
ACS is hoping to win FDA approval to market the device for use during CPR for adults with non-traumatic cardiac arrest, according to the FDA memo.
The technology is part of a suite of ResQ devices, including the ResQPump and ResQPOD cardiopulmonary resuscitation assistance devices.
ACS’s ResQCPR combines the company’s ResQPOD impedance threshold device with the ResQPUMP active compression decompression system. The company late last year touted positive results from a National Institutes of Health sponsored study finding that combining the two approaches helps improve neurologically-intact survival rates for patients who suffer in-hospital cardiac arrest.
