Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications for Use: The AxiumTM Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**
*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study.
**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively.
Contraindications: Patients contraindicated for the Axium Neurostimulator System are those who are unable to operate the system and are poor surgical risks. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to proceed to the INS procedure.
Potential Adverse Events: The implantation of a neurostimulation system involves risk. Implant Manual must be reviewed for detailed disclosure.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.
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