Clinical accuracy and safety using the SynchroMed II intrathecal drug infusion pump.

ABSTRACT:

Background and objectives

We evaluated the infusion accuracy and device-related safety of implantable drug infusion pumps in subjects with chronic pain or severe spasticity.

Methods

Nine centers in the United States enrolled patients receiving intrathecal drug delivery systems to manage chronic pain and/or severe spasticity. Infusion accuracy was assessed at 6 and 12 months by comparing syringe-measured delivered volumes to programmer-predicted volumes. Safety was evaluated through analysis of adverse events. Separate laboratory testing conducted by the manufacturer also evaluated infusion accuracy.

Results

Eighty of 82 enrolled subjects were implanted. Sixty-five and 54 subjects, respectively, were analyzable for accuracy at 6 and 12 months. On average at 6 months, t

SUBMITTER: Wesemann K 

PROVIDER: S-EPMC4218763 | biostudies-literature | 2014 Jul-Aug

REPOSITORIES: biostudies-literature