The Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee met on July 16, 2001 in Rockville, MD. In closed committee deliberation the FDA staff presented to the panel a summary update of ongoing projects within the Anesthesia Division. The open public hearing began at 12 noon. There were no requests from the public to make presentations during the open public hearing.
During the open committee discussion the panel reviewed a PMA supplement from SensorMedics Inc. The SensorMedics high frequency oscillatory ventilator (HFOV) PMA was approved for treatment of infants in 1991, and for treatment of respiratory failure in children in 1995. This PMA supplement was for treatment of adults and large children who have acute respiratory failure. The device modifications include an increase in the flow rates and oscillation pressure, required for treatment of larger patients.
SensorMedics presented data from a clinical trial in which 75 patients were randomized to HFOV treatment and 73 patients were randomized to conventional ventilator treatment. The fraction of patients who were alive and not on respiratory support at 30 days was similar for conventional ventilator treatment (26%) and for the HFOV ventilator group (21%). The prospectively defined endpoint for non-inferiority was not met. However, survival at one month was on the average better with HFOV than with conventional therapy (63% vs 48%), as was the 6 month survival (53% vs 41%). Although the differences did not achieve statistical significance, the panel concluded that, with respect to survival, HFOV was likely to be at least as effective as conventional ventilation therapy.
The panel also considered whether the conventional therapy control group treatment protocol, defined in 1996, was adequate. The panel concluded that the control group treatment protocol was within the range of good current practice. All seven voting members voted that the PMA supplement was approvable with one condition. The condition was that labeling would state that no data are available about the use of this device for treatment of patients who had chronic obstructive pulmonary disease or asthma, and that there was no experience with the administration of aerosolized medications during HFOV ventilation. The meeting was adjourned at approximately 3:30 p.m.
Michael Bazaral, M.D., Ph.D.,
Executive Secretary, (301) 443-8609, ext 140
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