TARGET (Abbott) DRG treatment for lower-limb CRPS Types I and II

Objective:  To demonstrate continued safety of the Axium Neurostimulator System for dorsal root ganglion (DRG) stimulation.

Eligibility Criteria

Inclusion Criteria

  1. Subject is male or female between 22 and 75 years of age.
  2. Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
  3. Subject has a baseline VAS score of > 60 mm for overall pain at the time of the baseline assessment.
  4. Subject is willing and able to comply with the study requirements.
  5. Subject is able to provide written informed consent.
  • Exclusion Criteria

  1. Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
  2. Subject is currently involved in medically related litigation, including workers compensation.
  3. Subject has a life expectancy of less than one year.
  4. Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
  5. Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
  6. Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted.
  7. Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.

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