PROMETRA® II PROGRAMMABLE PUMP
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Inflammatory mass has been associated with a wide range of doses and concentrations of opioids. No
dose or concentration of Infumorph can be considered completely free of risk from inflammatory
mass. The risk of inflammatory mass occurrence appears to be cumulative over time and increases
with higher concentrations and doses of opioids.
Clinical Studies
The performance and safety of the Prometra Pump was examined in an open-label, non-randomized,
multi-center study. This study was designed to demonstrate the accuracy and safety of the pump’s
delivery of Infumorph into the intrathecal space.
The primary endpoint of the study was to demonstrate accuracy of drug delivery is within the range of
85-115% through six months post implantation. Additional endpoints evaluated the safety profile, as
determined by the rate of device-related serious adverse events and device complications.
A total of 110 Patients enrolled in the study were implanted with the Prometra Pump. Patients eligible
for enrollment were suffering from cancer pain requiring strong opioids, chronic, non-malignant pain,
or required an implantable pump system replacement due to malfunction or battery depletion. The
average patient age at implant was 56 years with 54% male and 46% female patients.
Patients were followed monthly for the first 6 months post implantation. During each monthly follow-
up visit, the pump was refilled and infused volumes of medication were documented. Drug delivery
accuracy and adverse events were documented at the monthly visits.
Results
The accuracy of drug delivery was found to be 96.8% with a 90% confidence interval of 95.5% - 97.7%.
This met the required range of 85% - 115%.
Adverse Events reported during the study are shown in Table 1.
Table 1: Adverse Events Reported as Possibly, Probably, or Definitely Related to the Device or
Study Procedure
System Organ Class
Preferred Term
N (%)
Gastrointestinal Disorders
Nausea
15 (14)
Vomiting
8 (7)
General Disorders and
Administration Site Conditions
Implant Site Pain
20 (18)
Implant Site edema
11 (10)
Implant Site Erythema
9 (8)
Implant Site Swelling
4 (4)
Pain
4 (4)
Implant Site Inflammation
3 (3)
Drug Withdrawal Syndrome
2 (2)
Implant Site Haemorrhage
2 (2)
Pyrexia
2 (2)
Tenderness
2 (2)
Infections and Infestations
Incision Site Infection
4 (4)
