Clinical Trial of the Senza™ SCS System in the Treatment of Chronic Upper Limb and Neck Pain

Study subjects will be identified from the pool of candidates for SCS therapy affiliated
with, or referred to, the clinical sites. Subjects will participate in this investigational
plan that includes entry criteria evaluation, Baseline assessments, trial stimulation phase,
and post-trial assessment. Subjects with a successful Trial Phase will receive a permanent
implant of an Implantable Pulse Generator (IPG) and leads, and undergo 12 months of
stimulation delivery with assessments at 1, 3, 6, 9, and 12 months Post-Permanent Device
Activation.

Subjects who sign the informed consent will undergo evaluations to determine eligibility for
the study based on the inclusion and exclusion criteria. Baseline assessments will also
include measures for pain, disability, functioning, medication use, quality of life,
depression and sleep.

Implantation and use of the Senza System will follow the Nevro Physician's Manual and
supporting Manuals. Subjects will undergo a Trial Phase lasting up to 14 days to determine
his/her response to SCS therapy. Following the Trial Phase with external device stimulation,
subjects will be assessed for their pain, and those who have a successful Trial Phase will be
eligible to proceed to permanent implantation of a SCS system.

Following permanent device implant, the IPG will be "activated" and thus, stimulation
delivered on an ongoing basis for 12 months. At 1 month and 9 months following Post-Permanent
Device Activation, assessments of pain and adverse events will be made. At 3, 6, and 12
months Post-Permanent Device Activation, subjects will be assessed for pain and adverse
events as well as disability, functioning, medication use, quality of life, depression and
sleep. Patient Global Impression of Change, Clinician Global Impression of Change and subject
satisfaction will be recorded at 3 and 12 months Post-Permanent Device Activation.

Inclusion Criteria:

1. Have been diagnosed with chronic, intractable pain of the upper limb and/or neck
related to the cervical spine and/or neuropathic arm pain

2. Considering daily activity and rest, have average upper limb and/or neck pain
intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment

3. Be an appropriate candidate for the surgical procedures required in this study based
on the clinical judgment of the implanting physician

4. Be on stable pain medications, as determined by the Investigator, for at least 28 days
prior to enrolling in this study and be willing to stay on those medications with no
dose adjustments until activation of the permanently implanted SCS device

5. Be 18 years of age or older at the time of enrollment

6. Be willing and capable of giving informed consent

7. Be willing and able to comply with study-related requirements, procedures, and visits

8. Be capable of subjective evaluation, able to read and understand English-written
questionnaires, and are able to read, understand and sign the written inform consent
in English.

9. Have adequate cognitive ability to use a patient programmer and recharger as
determined by the Investigator

Exclusion Criteria:

1. Have a medical condition or pain in other area(s), not intended to be treated with
SCS, that could interfere with study procedures, as determined by the Investigator

2. Have evidence of an active disruptive psychological or psychiatric disorder as
determined by a psychologist

3. Have a current diagnosis of a progressive neurological disease as determined by the
Investigator

4. Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive
peripheral vascular disease or uncontrolled diabetes mellitus

5. Have a condition that the Investigator determines would significantly increase
perioperative risk

6. Significant cervical stenosis

7. Any previous history of surgery on the posterior elements (laminectomy, posterior
fusion)

8. Be benefitting within from an interventional procedure and/or surgery to treat upper
limb pain (Subjects should be enrolled at least 30 days from last benefit)

9. Have an existing drug pump and/or another active implantable device such as a
pacemaker

10. Have a condition currently requiring or likely to require the use of MRI or diathermy

11. Have metastatic malignant disease or active local malignant disease

12. Have a life expectancy of less than 1 year

13. Have an active systemic or local infection

14. Be pregnant (if female and sexually active, subject must be using a reliable form of
birth control, be surgically sterile or be at least 2 years post-menopausal)

15. Have within 6 months of enrollment a significant untreated addiction to dependency
producing medications or have been a substance abuser (including alcohol and illicit
drugs)

16. Be concomitantly participating in another clinical study

17. Be involved in an injury claim under current litigation -