Circulatory System Devices Advisory Panel Provides Favorable Recommendation to FDA on Risk-benefit Profile of ResQCPR System
May 16, 2014 — Advanced Circulatory, makers of medical devices providing Intrathoracic Pressure Regulation (IPR) Therapy, will continue to work with the U.S. 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 May 6.
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 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’s ResQCPR System consists of the ResQPOD Impedance Threshold Device (ITD) 16 and the ResQPUMP Active Compression Decompression CPR (ACD-CPR) device. The ResQPOD ITD regulates airflow into the lungs during CPR and is intended to enhance negative pressure in the chest, allowing more blood to be pulled back to the heart and lowering intracranial pressure. The therapy is designed to increase cardiac output, blood pressure, and blood flow to the brain and other vital organs. The ResQPUMP (CardioPump in the European Union) ACD-CPR Device is used to perform active compression decompression (ACD) CPR, which is intended to improve conventional CPR by promoting complete and active chest wall recoil. The synergistic combination of these two devices is designed to enhance the vacuum effect in the chest, and has been shown in European clinical and pre-clinical studies to provide near-normal circulation during cardiac arrest. The ResQCPR data presented at the panel meeting demonstrate a 52% increase in survival with favorable neurological outcome (Modified Rankin Scale score of ≤ 3) at hospital discharge for patients who suffer out-of-hospital sudden cardiac arrest as compared to treatment with standard CPR.
For more information: advancedcirculatory.com