Abstract
The Model 8831 Personal Therapy Manager (PTM) offers a patient-controlled analgesia (PCA) option for the SynchroMed Infusion System (Medtronic Inc., Minneapolis, MN). The safety and effective operation of the PTM activator was evaluated in 45 patients in five European centers receiving intrathecal drug infusion for the treatment of chronic pain via a SynchroMed pump. The total volume of drug delivered intrathecally over a four-week follow-up period was calculated. Adverse events were recorded and pain levels were measured via the Visual Analog pain Scale (VAS), Brief Pain Inventory, and SF-12 Quality of Life scores. Patient satisfaction with the device and its instruction manual was also assessed by questionnaire. The expected and calculated intrathecal drug volumes (and therefore drug doses) were the same, demonstrating that the device worked as intended. There were no device-related serious adverse events. Overall, 96% of patients were satisfied with the activator. Patients appreciated being able to control their pain and considered the device and its instructions easy to use. The PTM was shown to be safe and functioning properly in the intrathecal treatment of pain. The successful addition of a PCA function to the SynchroMed system may create a new standard in intrathecal pain therapy.
Published Version
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