Advanced Circulatory, makers of medical devices providing intrathoracic pressure regulation (IPR) therapy, will continue to work with the Food and Drug Administration (FDA) on a pathway to premarket approval (PMA) for the company’s ResQCPR system, based on recommendations from the FDA Circulatory System Devices Advisory Panel meeting on 6 May 2014.
The panel considered approval of the ResQCPR System for use in the performance of CPR to increase the likelihood of survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest.
The panel voted unanimously that there is a reasonable assurance that the device is safe, and a majority agreed that the benefits of the ResQCPR System outweigh the risks for the device’s proposed indications.
While the panel members questioned whether the data provided a reasonable assurance of effectiveness of the system based on the numerous statistical analyses presented by the company and FDA at the meeting, several explained their positive vote on risk-benefit by stating that there was a strong "signal" of effectiveness and indicated that this should be studied in a post-market setting.
The panel’s discussion also focused on the complexity of performing prehospital cardiac arrest research and the need to find innovative solutions to improve survival of the nation’s third leading cause of death, cardiac arrest.
The ResQCPR system is comprised of the ResQPOD ITD 16 and the ResQPUMP active compression decompression CPR (ACD-CPR) device. The company is seeking approval of the product combination for use in the performance of CPR to improve the likelihood of survival with favorable neurological function in adult patients with non-traumatic cardiac arrest based on the results of its pivotal clinical study, the ResQTRIAL.
The ResQCPR system is Advanced Circulatory’s next IPR Therapy technology, which is intended to regulate negative intrathoracic pressure to enhance blood flow in states of poor perfusion, including cardiac arrest and shock.
Advanced Circulatory CEO and director Mike Black noted that the company looks 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.