A joint meeting of the Circulatory System Devices Panel and the Neurological Devices Panel was held on September, 2004. The Panel discussed and made recommendations regarding clinical trial design in the evaluation of cardiopulmonary resuscitation (CPR) enhancing devices/therapies for cardiac arrest patients.
The panel heard presentations by FDA and several public speakers regarding CPR devices employed for cardiac arrest patients. The FDA requested recommendations from the Panel regarding the type of data and study required to effectively evaluate performance of these devices. The panel agreed that a single arm study with historical controls would not be appropriate. The panel recommended a randomized prospective study for CPR devices. The panel suggested that clinical studies need not be limited to patients who have arrested in the field, but could also include in-hospital cardiac arrest patients. However, the panel recommended that the two populations should be evaluated separately. The panel also discussed the use of data from post-market registry, the evaluation of neurological endpoints and length of follow-up for safety and efficacy.
The panel also heard presentations by FDA and several public speakers regarding the effects of mild hypothermia employed for cardiac arrest patients. Several panel members believed that the existing data in the literature, although small in number of patients enrolled, are adequate to support the safety and effectiveness of surface cooling for achieving mild hypothermia in unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest. The panel indicated that endovascular cooling catheters raise different safety issues. The safety data needed for cooling catheters would be dependent upon the device characteristics and the results of animal studies performed with the device.
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