The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain

Inclusion criteria

• Subject must be at least 21 years of age.
• Subject must have experienced chronic pain for at least 6 months.
• Subject must not presently be on intrathecal therapy but must be considered a candidate for intrathecal analgesia by his pain specialist; or, a subject already on intrathecal therapy must be in need of a replacement intrathecal pump and catheter.
• Subject must be capable of giving informed consent.
• Subjects who agree to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician.
• Subjects who agree to periodic drug testing.
• Subject must be capable and willing to follow all study-related procedures, including returning for monthly refills.
• Subject must be cognitively intact and, in the opinion of the Investigator, capable of using the Patient Remote.
• Subject who is not already successfully treated with intrathecal analgesic therapy must be responsive to a trial of intrathecal or epidural morphine.
• Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
• Documented failure to respond to less invasive methods of pain control (such as physical or behavioral modifications).
• Ineffective pain control with single or multiple systemic analgesic treatments (oral, rectal, IV or transdermal) or had intolerable side effects.
• Cancer pain requiring strong opioids or non-malignant pain with average Visual Analog Scale (VAS) score of ≥ 4/10.
• Subjects who can receive an MRI.
• Subjects must be able to hear and respond to audible alarms or agree to have a support person available who is able to hear and respond to audible alarms.

Exclusion criteria

• Subject is a female who is pregnant or is planning a pregnancy.
• Subject is a nursing mother.
• Subject has at the site chosen for implantation a skin condition that would prevent the implantation procedure.
• Subject has participated in an investigational drug or device trial within 4 weeks prior to enrollment.
• Subject has any known or suspected allergy to morphine or to the materials of the infusion pump or intrathecal catheter.
• Subject shows signs of active, systemic infection.
• Subject has a known central nervous system contraindication to intrathecal therapy, including but not limited to severe spinal canal stenosis or spinal cord compression.
• Subject has a body size that is insufficient to accept the bulk and weight of the pump.
• Subject is allergic to morphine sulfate, or for whom morphine sulfate is contraindicated.
• Subject has a condition requiring diathermy procedures.
• Subject has a life expectancy of less than 9 months.
• Subject cannot independently comprehend and participate in the required assessments, including responding to the QOL, BPI, ODI and PGIC measurement tools.
• Subject is not considered to be medically or psychologically appropriate for pump implantation.
• Subject has a urine drug screen result which indicates the use of prescription drugs or controlled substances not on the order of a physician.
• Subjects with an ASA Physical Status >IV.
• Subjects with a history of spinal instability, or grade II spondylolisthesis or greater.
• Previously implanted subjects with spinal MRI findings of inflammatory mass prior to the implantation procedures.
• Subjects who are unable or unwilling to return to all of the required follow-up visits.
• Subjects who are unwilling to sign the informed consent.
• Subjects who are exposed to high-current industrial equipment (i.e. electricians or electrical engineers) or regularly exposed to MRI equipment (i.e. MRI technicians, MRI engineers and MRI clinicians).
• Subjects with active implanted devices such as pacemakers, defibrillators, cochlear implants and neurostimulators or other medical device use that can interfere with the function of the implanted intrathecal pump.