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Accuracy of the Prometra® Programmable Intrathecal Pump System in a Prospective, Non-Randomized Clinical Trial

Accuracy of the Prometra® Programmable Intrathecal Pump System in a Prospective, Non-Randomized Clinical Trial

Authors: Richard Rauck, M.D., Steven Rosen, M.D., John Barsa, M.D., Timothy Deer, M.D., Elmer Dunbar, M.D., Gopala Dwarakanath, M.D. and Gurpreet Padda, M.D.

Published: NANS 12/4/08

Poster presents data on 957 refill procedures, illustrating 97.3% ±0.4% accuracy. There was no significant difference between accuracy of refills at different flow rates quartiles of 0.0 - 0.2mL, 0.2 0.3mL, 0.3 0.4mL, and >0.4mL were used. The distribution of refill accuracy is illustrated, as well as the accuracy by month post- implant. Two months post-implant were illustrated to be significantly different from other months month 1 (mean accuracy of 93.1% ±0.8%), and 4 months post-op (mean accuracy 101.2% ± 3.3%). Much of the data leading to the statistically significant differences are anticipated to be due to human (measurement) error attributed to reading volumes at very low flow rates <0.5mL/month.