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.
- Subject is male or female between 22 and 75 years of age.
- Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
- Subject has a baseline VAS score of > 60 mm for overall pain at the time of the baseline assessment.
- Subject is willing and able to comply with the study requirements.
- Subject is able to provide written informed consent.
- Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
- Subject is currently involved in medically related litigation, including workers compensation.
- Subject has a life expectancy of less than one year.
- Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
- Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
- Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted.
- 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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