Prometra Post-Approval Study

A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System

The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

This study is proposed under part of the post-Premarket Approval (PMA) requirements. This study is a prospective, non-randomized, open-label, multicenter study. It will be performed at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years.

Inclusion Criteria:

1. Patient meets at least one of the following:

   • is suffering from malignant pain (i.e., cancer pain)
   • has chronic, non-malignant pain
   • subject was enrolled in PUMP I or PUMP II study and chooses to participate in this Post-Approval study
   • Patient with an existing implantable pump for pain therapy that requires replacement

2. Patient is at least 22 years of age.

3. Investigator considers the patient to be able and willing to fulfill all study requirements.

4. Patient has provided written informed consent to participate in the study.

Exclusion Criteria:

1. Patient meets any of the contraindications for use of the Prometra System
2. Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.
3. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.