In January of 2007, Flowonix began a clinical trial to evaluate the safety, efficacy, and accuracy of the Prometra® Programmable Pump.
The objective of the study was to determine whether the Prometra Programmable Implantable Pump System was safe, effective, and accurate for the delivery of preservative-free morphine sulfate approved for intrathecal administration. The study used a non-randomized, open-label, multi-center approach, and enrolled 110 patients from seven investigational sites.
Successful outcomes were benchmarked at industry standards for programmable intrathecal pumps.
Data was to be collected at baseline, monthly for six months, and quarterly after six months. The study illustrated that Prometra was accurate, safe and effective.
The accuracy of the pump was found to be significantly greater than the industry benchmark of ±14.5%. Further studies will explore what impact a significantly greater accuracy has upon improvement of function and quality of life.
Additionally, Flowonix is proud to have published several papers on the programmable infusion system: