Indications For Use - Abbott NeuroSphere 3875 User Manual

used with the generator to help the patient manage
prescribed stimulation programs.

Indications for Use

This neurostimulation system is indicated for spinal
column stimulation via epidural and intraspinal 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. CRPS II (causalgia) is defined as a painful
condition arising from damage to a nerve. Nerve
damage may result from traumatic or surgical nerve
injury. Changes secondary to neuropathic pain seen in
CRPS I (RSD) may be present, but are not a diagnostic
requirement for CRPS II (causalgia).
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