On Tuesday, May 6th, the Circulatory System Devices Panel of the Medical Device Advisory Committee provided favorable.
On Tuesday, May 6th, the Circulatory System Devices Panel of the Medical Device Advisory Committee provided favorable recommendation to the FDA 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 RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during CPR in an attempt to enhance venous return to the heart and blood flow to vital organs.
The panel voted unanimously 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 some of the members of the panel questioned the effectiveness of the device, several members of the panel explained their positive vote on risk-benefit profile by stating that there was a strong “signal” of effectiveness and indicated that this should be studied in a post-market setting. The panel also discussed the complexity of performing cardiac arrest research and the need to find solutions to improve survival of the nation’s third leading cause of death – cardiac arrest. The CEO of Advanced Circulatory, Mike Black, stated “We appreciate the positive feedback of the panel on the safety and risk-benefit profile of the RESQCPR System. 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.”
The agency is not obligated to follow its panel’s recommendation, but normally does so.
Session II of this meeting of the Circulatory System Devices Panel, originally scheduled for Wednesday, May 7th, has been postponed.
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