Presented at the 2012 AAPM Annual Meeting « Back

Final Study Results for Multicenter Evaluation of Drug Delivery Accuracy with the Prometra® Intrathecal Programmable Infusion Pump

John E Barsa, MD, jbarsa@mac.com, AAPM, APS, American Society of Neuromodulation, American Medical Association, American Society of Regional Anesthesia, American Society of Anesthesiologists, Hillsborough County (Florida) Medical Society, Florida Society of Anesthesiologists, Tampa, Florida

Introduction: Accuracy of drug delivery is an important therapeutic component when treating pain patients with an implantable pump. Pumps currently market approved are labeled for accuracy of +/- 15%. The Prometra pump design elements should improve accuracy. During a prospective, multicenter FDA-approved clinical study (Prometra’s Utilization in Mitigating Pain, or PUMP) accuracy of the Prometra programmable pump was evaluated. The study has concluded and final results are available. Materials and Methods: The PUMP study was a prospective, open-label evaluation of the Prometra pump system (Medasys, Inc., Mt. Olive, NJ) to treat chronic pain with MSO4. After obtaining IRB approval at seven clinical sites, 110 patients (age: 56 ± 13, gender: 51F) were enrolled after giving informed consent. Baseline data are collected pre-implant and follow-up is monthly for the first 6 months post-implant and then quarterly. Refill accuracy was calculated by dividing the total measured delivered volume by total volume programmed for delivery. Data were tabulated by an independent third party (inVentiv Clinical Solutions, The Woodlands, TX). Results: After a total of 100,632 device days of follow-up, mean accuracy of drug delivery was 97.8%, SD 3.0, median 98.2, range 81.8-104.0. Ninety percent confidence interval 97.4-98.3%. Conclusions: As previously reported, final study results show that the Prometra pump was accurate over the course of follow-up and over a range of flow rates.

Funding: None