The FDA’s Circulatory System Devices Advisory Panel voted this month to recommend approval for Advanced Circulatory’s ResQCPR system for use during emergency CPR to help increase survival and minimize brain damage.
The panel voted unanimously that the device appears safe, but a few panelists had questions about the effectiveness of the technology. The members agreed generally that the system should be studies in a postmarket setting to determine whether current "signals" of effectiveness prove out.
The system is comprised of the ResQPump compression/decompression device and the ResQPOD impedance threshold valve. Together the devices aim to help boost blood flow and reduce the likelihood of incurring brain damage in patients experiencing non-traumatic cardiac arrest.
"We appreciate the positive feedback of the panel on the safety and risk-benefit profile of the ResQCPR System," CEO and director Mike Black said in prepared remarks. "We look forward to working with the FDA to take the panel’s recommendation into consideration and complete the next steps required to approve the ResQCPR System."
Advanced Circulatory late last year touted positive results from a National Institutes of Health sponsored study finding that the new CPR system helps improve neurologically-intact survival rates for patients who suffer in-hospital cardiac arrest.