TARGET Post-Approval Study

A maximum of 376 adult subjects with moderate to severe chronic, intractable, pain of the
lower limbs due to CRPS types I and II will undergo a trial of the Axium Neurostimulator
System across 40 study sites in the United States. Only subjects who report a 50% or greater
reduction in overall pain intensity through direct patient-reported percentage of pain relief
will receive the permanent implant. Subjects will then return to the office for follow-up at
1, 3, 6 and 12 months post-permanent implant.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.