GAITHERSBURG, MD — Members of the Food and Drug Administration (FDA) Circulatory System Devices Advisory Panel voted in favor of approving the ResQCPR System (Advanced Circulatory Systems, Roseville, MN) to perform CPR.
The panel reviewed the evidence that this system could be used to provide CPR to adults with nontraumatic cardiac arrest and to increase the likelihood of survival with favorable neurologic function and deemed that the system had a favorable risk/benefit profile.
The system comprises two devices—the ResQ POD impedance threshold device (or valve), which is already approved by the FDA, and the ResQ PUMP active compression/decompression device.
The impedance-threshold valve is placed in the patient's mouth, to limit passive lung inflation during the chest-decompression phase, boosting intrathoracic pressures and enhancing perfusion of the heart and brain.
The compression/decompression device has a double-grip handle that attaches to the patient's chest with a suction cup, which allows the rescuer to push to deliver compressions and lift for decompressions.
The system is designed to regulate negative intrathoracic pressure to enhance blood flow in states of poor perfusion, including cardiac arrest and shock.
As reported earlier by heartwire , a randomized trial suggested that when paramedics perform out-of-hospital CPR using this system, it boosts a patient's chances of being discharged with good neurologic function. However, an accompanying editorial pointed to mixed results in earlier studies.
In the current safety and efficacy review, the advisory panel voted unanimously that there is a reasonable assurance that the device is safe.
A majority agreed that the benefits of the ResQCPR System outweigh the risks for the device's proposed indications.
Some panel members questioned whether the many statistical analyses presented by the company and FDA at the meeting provided a reasonable assurance of effectiveness of the system.
However, several panel members explained their positive vote on risk/benefit ratio by stating that there was a strong "signal" for effectiveness, which should be studied in a postmarket setting.
The panel also discussed the complexity of performing prehospital cardiac arrest research and the need to find innovative solutions to improve survival from cardiac arrest, the third leading cause of death in the US, according to a statement issued by the device manufacturer.
"We appreciate the positive feedback of the panel on the safety and risk/benefit profile of the ResQCPR System," Advanced Circulatory's CEO and director, Mike Black, commented in a statement. "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."
Heartwire from Medscape © 2014 Medscape, LLC
Cite this: FDA Advisory Panel Recommends Approval of New CPR System - Medscape - May 09, 2014.