Authors: Timothy Deer, MD, Steven Rosen, MD, Elmer Dunbar, MD, John Barsa, MD, Gurpreet Padda, MD, Gopala Dwarakanath, MD and Richard Rauck, MD
Published: Napa 8/13/2009
Poster presents efficacy data on 18 months of median daily dosing and 1,098 refill procedures. Mean accuracy of refill visits was determined to be 97.4% with a 90% confidence interval of 96.8% - 98.0%. Accuracy each month of the study was analyzed and determined to be between 92.5% and 103%, well within the target endpoints of 85% - 115%. Accuracy between different flow rates was also analyzed, as well as function of residual volume; accuracy was consistent throughout. It was specifically noted that accuracy remained consistently high at high residual volumes (16-20mL), which indicates high accuracy at low flow rates. When compared to baseline, efficacy data illustrated statistically significant decreases in mean pain and disability scores at all visits. 84% of patients recorded improvements in VAS, 76% in NRS, and 68% in ODI. Finally, no unanticipated adverse events were attributable to the device or the procedure.