A Multi-Center Controlled Study to Characterize the Real-world Outcomes of High Rate Spinal Cord Stimulation Therapy Using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System
Phase: NA
Conditions: Chronic Pain
Sponsor: Boston Scientific Corporation

 
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                                                                VELOCITY Protocol, 91113648 Rev/Ver AB 
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A Multi-Center Controlled Study to characterize the real-world outcomes 
of High Rate Spinal Cord Stimulation therapy using Boston Scientific 
(BSC) PRECISION Spinal Cord Stimulator System  
 
 
VELOCITY 
 
 
CLINICAL INVESTIGATION PLAN 
 
 
A4059 
 
Sponsored By 
Boston Scientific Corporation 
Neuromodulation 
 25155 Rye Canyon Loop 
Valencia, CA 91355 
United States of America 
 
 
International Representative 
Boston Scientific Limited 
Ballybrit Business Park, 
Galway, Ireland 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 

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Contact Information 
 
Role 
Contact  
Clinical Contact 
Heleen Scholtes  
Clinical Project Manager 
Boston Scientific Neuromodulation 
Vestastraat 6 
6468 EX Kerkrade 
Netherlands 
Mobile: +31(0) 6 3987 9694 
Email: Heleen.scholtes@bsci.com 
 
Roshini Jain 
Director, Clinical Sciences 
Boston Scientific Neuromodulation 
25155 Rye Canyon Loop 
Valencia, CA 91355 
Phone: +1 661 949 4350 
Mobile: +1 469 766 9888 
E-mail: Roshini.jain@bsci.com 
 
Principal Investigator 
Vivek Mehta 
Consultant in Pain Medicine, Deputy Director 
Pain and Anaesthesia Research Centre 
St Bartholomew's Hospital 
West Smithfield 
London EC1A 7BE 
United Kingdom 
E-mail: vivek.mehta@mac.com 
 
 
 
 
Original Release: 04 December 2015, Version AA 
 
Current Version: 09 December 2016, version AB 
 
 
 
 
 

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Revision History 
 
Revision 
Number 
Release Date 
Template 
number and 
version 
Section 
Change 
Reason for 
Change 
AA 
04 December 
2015 
90702637 
AE 
NA 
NA as initial release 
NA 
AB 
09 December 
2016 
90702637 
AH 
All 
Update of standard 
protocol text 
BSC Protocol 
template update 
Contact 
information 
Updated 
Updated with 
change 
All 
Update to 
Programming 
Settings 
Clarified  
Programming 
Settings 
Data Collection 
Schedule 
Demography and 
Medical History items  
from screening to 
Baseline / 
Concomitant 
Medication at 
Standard of Care 
visits Optional  
Corrections 
All 
Updated References 
Updates 
References 
Section 17.2 
Investigator 
Responsibilities 
Section on Device 
accountability taken 
out 
NA due to the use 
of commercial 
device 

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2. Protocol Synopsis 
VELOCITY 
A Multi-Center Controlled Study to characterize the real-world outcomes 
of High Rate Spinal Cord Stimulation therapy using Boston Scientific 
(BSC) PRECISION Spinal Cord Stimulator System 
Primary 
Objective 
To characterize the real-world outcomes of high rate spinal cord stimulation 
(HR-SCS) therapy as an aid in the management of chronic intractable pain of 
the trunk, including unilateral or bilateral pain associated with the following: 
failed back surgery syndrome, intractable low back pain using the Boston 
Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave 
Technology. 
 
Planned 
Indication(s) for 
Use  
The Precision SCS System with MultiWave Technology is indicated as an aid in 
the management of chronic intractable pain. 
 
Test Parameters BSC PRECISION SCS System with MultiWave Technology at a stimulation 
rate of up to 10 kHz 
Control 
Parameters 
None: Each subject will serve as their own control. 
Study Design 
Prospective, multi-center, single-arm study 
Planned 
Number of 
Subjects 
Up to 60 implanted subjects 
 
Planned 
Number of 
Centers / 
Countries 
Up to 10 sites / Europe 
 
Primary 
Endpoint 
Low back pain responder rate at 3 months post-activation as compared with 
Baseline.  
**A responder is defined as ≥30% low back pain reduction from Baseline 
without change in opioids** 

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VELOCITY 
A Multi-Center Controlled Study to characterize the real-world outcomes 
of High Rate Spinal Cord Stimulation therapy using Boston Scientific 
(BSC) PRECISION Spinal Cord Stimulator System 
Secondary 
Endpoints 
The following secondary endpoints will be analyzed. Assessments required for 
deriving each endpoint are denoted in parentheses. 
• 
Change in average low back pain from Baseline to 3 months post-Activation 
(NRS) 
• 
Change in average leg pain from Baseline to 3 months post-Activation 
(NRS) 
• 
Percent pain relief of low back pain at 3 months post-Activation (PPR) 
• 
Percent pain relief of leg pain at 3 months post-Activation (PPR) 
• 
Change in low back pain with activity from Baseline to 3 months post-
Activation (NRS) 
• 
Change in leg pain with activity from Baseline to 3 months post-Activation 
(NRS) 
• 
Patient global impression of change at 3 months post-Activation (PGI-C) 
• 
Change in disability from Baseline to 3 months post-Activation (ODI v2.1a) 
• 
Change in quality of life from Baseline to 3 months post-Activation (SF-
36v2) 
Exploratory 
Endpoints 
The following exploratory endpoints will be analyzed. Assessments required for 
deriving each endpoint are noted in parentheses.  
• 
Change in average low back pain from Baseline through 6, 12 months post-
Activation (NRS) 
• 
Change in average leg pain intensity from Baseline through 6, 12 months 
post-Activation (NRS) 
• 
Change in low back pain intensity with activity from Baseline through 6, 12 
months post-Activation (NRS) 
• 
Change in leg pain intensity with activity from Baseline through 6, 12 
months post-Activation (NRS) 
• 
Percent pain relief of low back pain through 6, 12 months post-Activation 
(PPR) 
• 
Percent pain relief of leg pain through 6, 12 months post-Activation (PPR) 
• 
Change in average daily leg pain intensity (NRS) from Baseline through 3, 
12 months post-activation (Diary) 
• 
Change in average daily low back pain intensity (NRS) from Baseline 

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VELOCITY 
A Multi-Center Controlled Study to characterize the real-world outcomes 
of High Rate Spinal Cord Stimulation therapy using Boston Scientific 
(BSC) PRECISION Spinal Cord Stimulator System 
through 3, 12 months post-activation (Diary) 
• 
Change in disability from Baseline Visit through 6, 12 months post-
Activation (ODI v2.1a) 
• 
Patient global impression of change through 6, 12 months post-Activation 
(PGI-C) 
• 
Change in quality of life from Baseline Visit through 6, 12 months post-
Activation (SF-36v2) 
• 
Change in opioid prescription from Baseline through 6, 12 months post-
Activation (Concomitant Medications) 
Health 
Economics 
Endpoints 
Economic value of HR-SCS at 12 months post-Activation (RUI, SF-36v2, 
Concomitant Medications, Procedure Information) 
Safety 
Parameters 
Rate of occurrence of all device or procedure related adverse events (AEs), 
SAEs including serious adverse device events (SADEs), unanticipated serious 
adverse device effects (USADEs) through end of study. 
Method of 
Assigning 
Patients to 
Treatment 
N/A 
Study Schedule 
Study events occur at the following time points: 
• 
Screening Period (Up to 60 days following Informed Consent)  
• 
Baseline Visit (Medication Lock)  
• 
SCS Implant procedure (s)  
• 
Device Activation Visit (Day 0) 
• 
Programming Visit (45 ± 7 days post-Activation Visit) 
• 
3-Month Visit (90 ± 14 days post-Activation Visit) 
• 
6-Month Visit (180 ± 30 days post-Activation Visit) 
• 
12-Month Visit (365 ± 30 days post-Activation Visit). 
Study Duration 
Overall study duration is anticipated to take approximately 25 months from first 
patient enrollment to end of study close out activities. 

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VELOCITY 
A Multi-Center Controlled Study to characterize the real-world outcomes 
of High Rate Spinal Cord Stimulation therapy using Boston Scientific 
(BSC) PRECISION Spinal Cord Stimulator System 
Key Inclusion 
Criteria 
IC1. 
Complaint of persistent or recurrent low back pain for at least 180 days 
prior to Screening 
IC2. 
No back surgery within 6 months prior to Screening 
IC3. 
Average low back pain intensity of 6 or greater on a 0-10 numerical 
rating scale during Screening (NRS) as evaluated by interview 
IC4. 
Baseline Oswestry Disability Index score >40 and <81 
IC5. 
18 years of age or older when written informed consent is obtained  
IC6. 
Willing and able to comply with all protocol-required procedures and 
assessments/evaluations 
IC7. 
Subject signed a valid, EC-approved informed consent form (ICF) 
provided in local language 
Key Exclusion 
Criteria 
EC1. 
Average leg pain is greater than or equal to average low back pain 
during Screening (NRS). 
EC2. 
Radiographic evidence of spinal instability requiring fusion 
EC3. 
Require implantation of lead(s) in the cervical epidural space 
EC4. 
Requires implantation of paddle-style SCS lead(s) via a laminotomy 
and/or laminectomy 
EC5. 
Current systemic infection, or local infection in close proximity to 
anticipated surgical field, at Screening 
EC6. 
High surgical risk 
EC7. 
Previous spinal cord stimulation trial or is already implanted with an 
active implantable device(s) (e.g. pacemaker, drug pump, implantable 
pulse generator) 
EC8. 
A female who is pregnant, is breastfeeding, or is of childbearing 
potential and planning to get pregnant during the course of the study or 
not using adequate contraception.  
EC9. 
A condition currently requiring or likely to require the use of MRI or 
diathermy  
EC10. Participating (or intends to participate) in another drug or device clinical 
trial that may influence the data that will be collected for this study 
EC11. Any diagnosis or condition that, in the clinician’s best judgment, might 
confound reporting of study outcomes (e.g. pelvic pain, anginal pain, 
chronic migraine)  

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VELOCITY 
A Multi-Center Controlled Study to characterize the real-world outcomes 
of High Rate Spinal Cord Stimulation therapy using Boston Scientific 
(BSC) PRECISION Spinal Cord Stimulator System 
Statistical Methods  
Primary 
Statistical 
Hypothesis 
H0: πHR ≤ 0.20 
H1: πHR > 0.20 
where πHR is the proportion of responders* to high rate SCS treatment at 3 
months post-activation , and 0.20 is the Objective Performance Criteria (OPC). 
*A responder is defined as ≥ 30% low back pain reduction from Baseline 
without change in opioid intake. 
Statistical Test 
Method 
The primary statistical hypothesis will be tested using Fisher’s Exact test for a 
single proportion. 
Sample Size 
Parameters 
 
 
Test significance level () 
0.025 
1 or 2 sided test                            
1 
πHR 
0.40      
OPC 
0.20  
Power (1- β) 
0.90 
Attrition (%) 
10 
N 
60 
Interim 
Analyses 
This study will have a total of 2 looks, with one interim analysis at: 
• 36 subjects at 3 months post-Activation: futility and efficacy stopping 
• Up to 60 subjects at 3 months post-Activation: futility and efficacy stopping 
 
 
 

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3. Table of Contents 
2. 
PROTOCOL SYNOPSIS .......................................................................................................... 4 
3. 
TABLE OF CONTENTS .......................................................................................................... 9 
3.1. Table of Figures ...................................................................................................... 13 
3.2. Table of Tables ....................................................................................................... 13 
4. 
INTRODUCTION ................................................................................................................. 14 
4.1. Chronic Intractable Pain ....................................................................................... 14 
4.2. Conventional Spinal Cord Stimulation ................................................................ 14 
4.3. High Frequency Electrical Stimulation ................................................................ 15 
4.3.1. 
HF Stimulation for Pain ............................................................................. 15 
5. 
DEVICE DESCRIPTION ....................................................................................................... 16 
5.1. Device Labeling ...................................................................................................... 16 
6. 
STUDY OBJECTIVES .......................................................................................................... 17 
6.1. Primary Objective .................................................................................................. 17 
7. 
STUDY ENDPOINTS ............................................................................................................ 17 
7.1. Primary Endpoint .................................................................................................. 17 
7.2. Secondary Endpoints ............................................................................................. 17 
7.3. Exploratory Endpoints .......................................................................................... 17 
7.4. Health Economic Endpoints .................................................................................. 18 
7.5. Safety Parameters .................................................................................................. 18 
8. 
STUDY DESIGN .................................................................................................................. 18 
8.1. Scale and Duration ................................................................................................. 19 
8.2. Treatment Assignment........................................................................................... 19 
8.3. Justification for the Study Design ......................................................................... 20 
9. 
SUBJECT SELECTION ......................................................................................................... 20 
9.1. Study Population and Eligibility ........................................................................... 20 
9.2. Inclusion Criteria ................................................................................................... 20 
9.3. Exclusion Criteria .................................................................................................. 21 

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10. SUBJECT ACCOUNTABILITY .............................................................................................. 22 
10.1. Point of Enrollment ................................................................................................ 22 
10.2. Withdrawal ............................................................................................................. 22 
10.3. Subject Status and Classification .......................................................................... 23 
10.4. Enrollment Controls .............................................................................................. 23 
10.5. End-of-Study Action Plan ..................................................................................... 23 
11. STUDY METHODS .............................................................................................................. 23 
11.1. Data Collection ....................................................................................................... 23 
11.2. Screening Period (Up to 60 days following Informed Consent) ......................... 25 
11.3. Baseline Visit (Medication Lock) .......................................................................... 25 
11.4. SCS Implant Procedure (s) .................................................................................... 26 
11.5. Device Activation Visit ........................................................................................... 26 
11.6. Programming Visit (45 ± 7 days post-Activation Visit) ...................................... 27 
11.7. 3-Month Visit (90 ± 14 days post-Activation Visit) ............................................. 27 
11.8. 6-Month Visit (180 ± 30 days post-Activation Visit) ........................................... 28 
11.9. 12-Month Visit (365 ± 30 days post-Activation Visit) - End of Study ............... 28 
11.10. Unscheduled Study Visits ..................................................................................... 29 
11.11. Revision or Replacement of Leads, Extensions and/or IPGs ............................ 29 
11.12. Study Completion ................................................................................................. 29 
11.13. Source Documents ................................................................................................. 29 
12. STATISTICAL CONSIDERATIONS ....................................................................................... 30 
12.1. Primary Endpoint .................................................................................................. 30 
12.1.1. Hypotheses ................................................................................................. 30 
12.1.2. Sample Size ............................................................................................... 31 
12.1.3. Statistical Methods ..................................................................................... 31 
12.2. Secondary Endpoints ............................................................................................. 31 
12.3. Exploratory Endpoints .......................................................................................... 32 
12.4. Health Economic Endpoints .................................................................................. 32 
12.5. Safety Parameters .................................................................................................. 32 
12.6. Analysis Sets ........................................................................................................... 32 
12.6.1. Safety Analysis Set .................................................................................... 32 
12.7. Control of Systematic Error/Bias ......................................................................... 32 

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12.8. Number of Subjects per Investigative Site ........................................................... 33 
12.9. Eligibility of Subjects, Exclusions, and Missing Data ......................................... 33 
12.10. Data Analyses ........................................................................................................ 33 
12.10.1. Interim Analyses ........................................................................................ 33 
12.10.2. Subgroup Analyses .................................................................................... 34 
12.10.3. Justification of Pooling .............................................................................. 34 
12.10.4. Multivariable Analyses .............................................................................. 34 
12.11. Changes to Planned Analyses .............................................................................. 35 
13. DATA MANAGEMENT ........................................................................................................ 35 
13.1. Data Collection, Processing, and Review ............................................................. 35 
13.1.1. Electronic Questionnaires .......................................................................... 35 
13.1.2. Direct Data Upload .................................................................................... 35 
13.2. Study Assessments .................................................................................................. 36 
13.2.1. Adverse Events .......................................................................................... 36 
13.2.2. Concomitant Medications .......................................................................... 36 
13.2.3. Demography .............................................................................................. 36 
13.2.4. Pain Diary (Diary) ..................................................................................... 36 
13.2.5. Medical History ......................................................................................... 36 
13.2.6. Oswestry Disability Index version 2.1a (ODI v2.1a) ................................ 36 
13.2.7. Numerical Rating Scale (NRS) .................................................................. 36 
13.2.8. Patient Global Impression of Change (PGI-C) .......................................... 37 
13.2.9. Percent Pain Relief (PPR) .......................................................................... 37 
13.2.10. Procedure Information ............................................................................... 37 
13.2.11 Programming Parameters ........................................................................... 37 
13.2.12 Resource Utilization Inventory (RUI) ....................................................... 37 
13.2.13 SF-36v2 Health Survey (SF-36v2) ............................................................ 37 
13.3 Data Retention ........................................................................................................ 37 
14 AMENDMENTS ................................................................................................................... 38 
15 DEVIATIONS ...................................................................................................................... 38 
16 DEVICE/EQUIPMENT ACCOUNTABILITY .......................................................................... 38 
17 COMPLIANCE ..................................................................................................................... 39 
17.1 Statement of Compliance ....................................................................................... 39 
17.2 Investigator Responsibilities ................................................................................. 39 

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17.2.1 
Delegation of Responsibility ..................................................................... 41 
17.3 Institutional Review Board/ Ethics Committee ................................................... 41 
17.4 Sponsor Responsibilities ........................................................................................ 41 
17.4.1 
Role of Field Clinical Engineer/Field Clinical Specialist .......................... 42 
17.5 Insurance ................................................................................................................. 43 
18 MONITORING ..................................................................................................................... 43 
19 POTENTIAL RISKS AND BENEFITS .................................................................................... 43 
19.1 Risks Associated with the Commercial Device(s) ................................................ 43 
19.2 Risks associated with Participation in the Clinical Study .................................. 43 
19.3 Possible Interactions with Concomitant Medical Treatments ........................... 44 
19.4 Risk Minimization Actions .................................................................................... 44 
19.5 Anticipated Benefits ............................................................................................... 44 
19.6 Risk to Benefit Rationale ....................................................................................... 45 
19.7 Warnings and Precautions .................................................................................... 45 
20 SAFETY REPORTING .......................................................................................................... 45 
20.1 Definitions and Classification ............................................................................... 45 
20.2 Relationship to Study Device(s) ............................................................................ 48 
20.3 Investigator Reporting Requirements .................................................................. 48 
20.4 Boston Scientific Device Deficiencies .................................................................... 50 
20.5 Reporting to Regulatory Authorities / IRBs / ECs / Investigators .................... 50 
21 INFORMED CONSENT......................................................................................................... 50 
22 COMMITTEES .................................................................................................................... 52 
22.1 Safety Monitoring Process ..................................................................................... 52 
23 SUSPENSION OR TERMINATION ........................................................................................ 52 
23.1 Premature Termination of the Study ................................................................... 52 
23.1.1 
Criteria for Premature Termination of the Study ....................................... 52 
23.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC Approval .................................................................................................. 52 
23.3 Requirements for Documentation and Subject Follow-up ................................. 53 
23.4 Criteria for Suspending/Terminating a Study Site ............................................. 53 

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24 PUBLICATION POLICY ....................................................................................................... 54 
25 BIBLIOGRAPHY .................................................................................................................. 54 
26 ABBREVIATIONS AND DEFINITIONS .................................................................................. 57 
 
 
3.1. Table of Figures 
Figure 8-1: VELOCITY Study Design ................................................................................... 19 
 
3.2. Table of Tables 
Table 5-1 High Rate Stimulation parameters of the commercially-available PRECISION™ 
SCS System ......................................................................................................... 16 
Table 9-1 Inclusion Criteria .................................................................................................... 21 
Table 9-2 Exclusion Criteria ................................................................................................... 21 
Table 11-1: Data Collection Schedule .................................................................................... 24 
Table 11-2: Source Documentation Requirements ................................................................. 30 
Table 20-1: Safety Definitions ................................................................................................ 45 
Table 20-2: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event .................................................................................................................... 48 
Table 20-3: Investigator Reporting Requirements .................................................................. 48 
Table 26-1: Abbreviations ...................................................................................................... 57 
 

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4. Introduction 
4.1. Chronic Intractable Pain 
Chronic intractable pain is often defined as pain persisting for at least 6 months which has 
not responded to conservative treatment(s). The pain may be due to current or past nerve 
injury and causes significant disability, reduced work productivity, reduced quality of life, 
and significant cost burden. Early treatments for chronic pain typically include over the 
counter and prescription medications. Later treatments like physical therapy and 
interventional pain procedures (e.g. intraspinal injections, vertebroplasty, pulsed RF) are 
attempted, sometimes followed by chronic high dose opioids and back surgery, if indicated. 
If back surgery is unsuccessful in relieving the chronic pain, the patient can be labeled as 
having failed back surgery syndrome (FBSS). Spinal cord stimulation is an option in the 
well-selected patient with chronic low back and/or leg pain.  
4.2. Conventional Spinal Cord Stimulation 
SCS is effective for chronic intractable pain associated with a variety of conditions, 
including, but not limited to, FBSS (Carter et al., 2004, Taylor et al., 2004), complex regional 
pain syndrome (Sears et al., 2011), and low back pain and leg pain (Cameron et al., 2004). 
Spinal cord stimulation (SCS) is a less invasive treatment option for FBSS but has generally 
been reserved for patients who have failed multiple, and indeed all possible, repeat 
operations.  
With SCS, an implanted pulse generator (IPG) delivers electrical current to electrode(s) 
implanted in the epidural space. This current stimulates nerves and can be programmed to 
direct stimulation to the nerves innervating the painful location, resulting in a reduction of 
the intensity of that pain (Kumar et al., 2006). Before an SCS system is implanted, a patient 
often undergoes a screening trial with an electrode that is connected to an external stimulator 
that the patient wears outside of the body. The results of the screening trial can predict the 
patient’s outcome with an implanted system (Kumar et al., 2006).  
In SCS pain relief is realized when the nerves that innervate the painful region(s) are 
electrically stimulated (North et al., 1990). To increase the chance of success, the electrode 
contacts are programmed based on the patient feedback to various combinations of contact 
polarities (anodes and cathodes), pulse rate (or frequency), pulse amplitude (or current), and 
pulse width. Several studies have demonstrated significantly greater pain relief and improved 
functional capacity and health-related quality of life in patients with SCS (Kumar et al 2007, 
Kumar et al 2008) 
In 2004, the FDA approved the Boston Scientific Corporation (BSC) PRECISION™ Spinal 
Cord Stimulator (SCS) System as the first rechargeable system for treatment of chronic 
intractable pain of the trunk and limbs. The results of a multi-center, non-randomized study 
conducted with this system demonstrated more than 50% pain relief through a maximum 

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follow-up of 18 months, but the single-arm design and small number of subjects enrolled 
limit the strength of the conclusions (Oakley et al., 2007).  
4.3. High Frequency Electrical Stimulation 
Spinal cord stimulation as a treatment for chronic pain has been utilized since the 1960s. 
Stimulation is delivered on a pulsatile basis, with frequencies of pulse delivery typically 
programmed between 2 and 1200 Hz (1Hz = 1 pulse per second). High frequency (HF) 
electrical neurostimulation (generally referring to stimulation using >1200 Hz) has been 
studied by physiologists since the late 20th century (Geddes, 1984). Neurostimulation 
frequencies in those ranges have been employed in various biomedical applications, 
including muscle strengthening (Ward et al., 2001; Ward 2009), bladder dysfunction 
(Jezernik et al., 2002), cochlear stimulation (House and Berliner, 1986; Zhang et al., 2005; 
Mueller et al., 2011), obesity (Camilleri et al., 2008), and chronic pain (Smet et al., 2011 
a&b; Van Buyten et al., 2011). Stimulation of first order sensory nerves may exhibit a similar 
mechanism of action to spinal cord stimulation and therefore may provide an insight into the 
safety of spinal cord stimulation.  
 
4.3.1. HF Stimulation for Pain 
High-Frequency (up to 10 kHz) spinal cord stimulation has also been evaluated in chronic 
pain patients. Nevro Corporation’s Senza™ System (Menlo Park, CA) delivers electrical 
stimulation at higher rates than conventional SCS devices (Smet et al., 2011 a&b; Van 
Buyten et al., 2011). Data from previous European clinical studies suggest that Nevro’s 
therapy may be effective in treating leg and back pain and other challenging types of chronic 
pain that often do not respond to conventional spinal cord stimulation (Smet et al., 2011 a&b; 
Van Buyten et al., 2011).  
 
These data also indicate significant and sustained pain reduction in patients with chronic 
back and leg pain. This study reported that 87% of their patients had predominant back pain, 
and 80% had pain following prior one or more back surgeries. Study results showed that, 
following treatment with the Senza™ System, average back pain VAS scores dropped from 
8.4 at baseline to 1.9 at twelve month follow-up. Average VAS leg pain scores were reduced 
from 5.4 at baseline to 1.6 at twelve months. The Senza™ high-frequency spinal cord 
stimulation system is authorized for sale in Europe and Australia. In 2015, Nevro received 
FDA approval for their Senza™ system.  
 
Boston Scientific’s Precision SCS System with MultiWave Technology is capable of 
providing stimulation at rates up to 10 kHz. The purpose of this study is to characterize the 
real-world outcomes of HR-SCS therapy as an aid in the management of chronic intractable 
pain of the trunk, including unilateral or bilateral pain associated with the following: failed 
back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) 
PRECISION Spinal Cord Stimulator System with MultiWave Technology. 

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5. Device Description 
 
Boston Scientific’s Precision SCS System with MultiWave Technology is approved for sale 
in Europe (CE mark) and is capable of providing stimulation at rates up to 10 kHz. 
 
The Precision SCS System with MultiWave Technology includes an Implantable Pulse 
Generator (IPG), External Trial Stimulator (ETS), Remote Control (RC), External Charger, 
and Clinician’s Programmer (CP) and a portfolio of lead options. The IPG is rechargeable 
and is recharged transcutaneously by a charging unit.  
 
The following HR stimulation parameters are available as shown in Table 5-1. 
 
Table 5-1 High Rate Stimulation parameters of the commercially-available 
PRECISION™ SCS System 
Rate 
Pulse width 
Amplitude 
2-10 kHz 
20- 240 sec1 
0–9 mA 
1 In increments of 10 μsec, range of available Pulse Width will depend on the programmed frequency rate. 
 
5.1. Device Labeling 
Directions for use (DFU) will be provided to each Investigator. The commercial devices and 
packaging are physically identified and labeled as applicable. The device labeling contains 
the following information:  
• 
Device description 
• 
Model number 
• 
Serial number / Lot number as applicable  
• 
Device dimension (i.e. Length), as applicable 
• 
Manufacturing location and date 
• 
Expiration date (“use before date”), as applicable 
• 
Storage temperature, as applicable. 
 
 

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6. Study Objectives 
6.1. Primary Objective 
The primary objective of this study is to characterize the real-world outcomes of high rate 
spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable 
pain of the trunk, including unilateral or bilateral pain associated with the following: failed 
back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) 
PRECISION Spinal Cord Stimulator System with MultiWave Technology.  
7. Study Endpoints 
7.1. Primary Endpoint 
The primary endpoint is low back pain responder rate at 3 months post-activation where a 
responder is defined as ≥30% low back pain reduction from Baseline without change in 
opioids.  
7.2. Secondary Endpoints 
The following secondary endpoints will be analyzed. Assessments required for deriving each 
endpoint are denoted in parentheses. 
• Change in average low back pain from Baseline to 3 months post-Activation (NRS) 
• Change in average leg pain from Baseline to 3 months post-Activation (NRS) 
• Percent pain relief of low back pain at 3 months post-Activation (PPR) 
• Percent pain relief of leg pain at 3 months post-Activation (PPR) 
• Change in low back pain with activity from Baseline to 3 months post-Activation 
(NRS) 
• Change in leg pain with activity from Baseline to 3 months post-Activation (NRS) 
• Patient global impression of change at 3 months post-Activation (PGI-C) 
• Change in disability from Baseline to 3 months post-Activation (ODI v2.1a) 
• Change in quality of life from Baseline to 3 months post-Activation (SF-36v2) 
7.3. Exploratory Endpoints 
The following exploratory endpoints will be analyzed. Assessments required for deriving 
each endpoint are noted in parentheses.  
• Change in average low back pain from Baseline through 6, 12 months post-Activation 
(NRS) 

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• Change in average leg pain intensity from Baseline through 6, 12 months post-
Activation (NRS) 
• Change in low back pain intensity with activity from Baseline through 6, 12 months 
post-Activation (NRS) 
• Change in leg pain intensity with activity from Baseline through 6, 12 months post-
Activation (NRS) 
• Percent pain relief of low back pain through 6, 12 months post-Activation (PPR) 
• Percent pain relief of leg pain through 6, 12 months post-Activation (PPR) 
• Change in average daily leg pain intensity (NRS) from Baseline through 3, 12 months 
post-activation (Diary) 
• Change in average daily low back pain intensity (NRS) from Baseline through 3, 12 
months post-activation (Diary) 
• Change in disability from Baseline Visit through 6, 12 months post-Activation (ODI 
v2.1a) 
• Patient global impression of change through 6, 12 months post-Activation (PGI-C) 
• Change in quality of life from Baseline Visit through 6, 12 months post-Activation 
(SF-36v2) 
• Change in opioid prescription from Baseline through 6, 12 months post-Activation 
(Concomitant Medications) 
7.4. Health Economic Endpoints 
The following Health Economic Endpoint will be included in this study. Assessments 
required for deriving each endpoint are noted in parentheses. 
• Economic value of HR-SCS at 12 months post-activation (RUI, SF-36v2, 
Concomitant Medications, Procedure Information)  
7.5. Safety Parameters 
The study safety parameters include the following: 
• Rate of occurrence of all device or procedure related adverse events (AEs), SAEs 
including serious adverse device events (SADEs), unanticipated serious adverse 
device effects (USADEs) through end of study.  
8. Study Design 
The study is a prospective, multi-center, single-arm study using Precision SCS System with 
MultiWave Technology at a stimulation rate of up to 10 kHz.  

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The study is open label, thus the study participants, investigative site personnel, and the 
sponsor will not be blinded. All subjects will undergo permanent system implantation. The 
study design is shown in Figure 8-1. 
8.1. Scale and Duration 
The study will enroll up to 60 subjects at up to 10 centers in Europe. Enrollment is expected 
to take 4 months (approximately 1.5 subjects/site/month) and a subject’s participation in the 
study, from the point of enrollment until study completion, should last approximately 12-15 
months. The study is expected to last approximately 25 months from first patient enrolled 
until the end of study close-out activities.  
 
 
Figure 8-1: VELOCITY Study Design 
 
 
8.2. Treatment Assignment 
Eligible subjects, following written consent will receive stimulation at rates up to 10 kHz 
during the course of the study.  

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8.3. Justification for the Study Design 
The study is a prospective, multi-center, single-arm study using Precision SCS System with 
MultiWave Technology at a stimulation rate of up to 10 kHz. The purpose of the study is to 
characterize the real-world outcomes of HR-SCS therapy as an aid in the management of 
chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the 
following: failed back surgery syndrome, intractable low back pain using the Boston 
Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology. 
A multi-center design will minimize the impact on treatment outcome that may potentially 
result from differences in patient selection, regional differences in the patient demographic, 
and differences in investigator technique and patient management.  
A prospective study design will eliminate the bias associated with case selection in a 
retrospective review and will ensure that identical procedures are followed for data capture 
and review.  
The primary efficacy endpoint will be measured at 3 months post-Activation of the SCS 
system because this represents duration sufficient for a subject to have their programming 
parameters optimized as well as to allow for therapy to become stable at 10 kHz.  
9. Subject Selection  
9.1. Study Population and Eligibility  
Study candidates will be drawn from the population of patients resident in pain management 
or surgical medical practices. The study eligibility criteria are listed in Sections Error! R
eference source not found. and 0.  
9.2. Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 9-1) will be considered for 
inclusion in this clinical investigation, provided no exclusion criterion (see Table 9-2) is met. 

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Table 9-1 Inclusion Criteria 
Clinical 
Inclusion 
Criteria 
IC1. 
Complaint of persistent or recurrent low back pain for at least 180 days prior 
to Screening 
IC2. 
No back surgery within 6 months prior to Screening 
IC3. 
Average low back pain intensity of 6 or greater on a 0-10 numerical rating 
scale during Screening (NRS) as evaluated by interview  
IC4. 
Baseline Oswestry Disability Index score >40 and <81 
IC5. 
18 years of age or older when written informed consent is obtained  
IC6. 
Willing and able to comply with all protocol-required procedures and 
assessments/evaluations 
IC7. 
Subject signed a valid, EC-approved informed consent form (ICF) provided 
in local language 
9.3. Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 9-2) will be excluded from this 
clinical study. 
Table 9-2 Exclusion Criteria 
Clinical 
Exclusion 
Criteria 
EC1. Average leg pain is greater than or equal to average low back pain during 
Screening (NRS). 
EC2. Radiographic evidence of spinal instability requiring fusion 
EC3. Require implantation of lead(s) in the cervical epidural space 
EC4. Requires implantation of paddle-style SCS lead(s) via a laminotomy and/or 
laminectomy 
EC5. Current systemic infection, or local infection in close proximity to anticipated 
surgical field, at Screening 
EC6. High surgical risk 
EC7. Previous spinal cord stimulation trial or is already implanted with an active 
implantable device(s) (e.g. pacemaker, drug pump, implantable pulse 
generator) 
EC8. A female who is pregnant, is breastfeeding, or is of childbearing potential and 
planning to get pregnant during the course of the study or not using adequate 
contraception.  
EC9. A condition currently requiring or likely to require the use of MRI or 
diathermy  
EC10. Participating (or intends to participate) in another drug or device clinical trial 
that may influence the data that will be collected for this study 
EC11. Any diagnosis or condition that, in the clinician’s best judgment, might 
confound reporting of study outcomes (e.g. pelvic pain, anginal pain, chronic 
migraine) 

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10. Subject Accountability 
10.1. Point of Enrollment 
A subject will be considered enrolled in the study at the time that the informed consent form 
is signed. No study-related procedures or assessments can take place until the informed 
consent form is signed. All enrolled subjects will be included in the study analyses.  
If device implantation is unsuccessful, the subject will be followed for 2 weeks post 
implantation attempt to assess for procedure related adverse events. Implant failures will be 
withdrawn from the study and will be handled as described in Section 10.2.  
  
10.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented. If a subject withdraws from the 
clinical investigation, the reason(s) shall be reported. If such withdrawal is due to problems 
related to device safety or performance, the investigator shall use local treatment protocols to 
determine the patient’s options for therapy.  
While study withdrawal is discouraged, subjects may withdraw from the study at any time, 
with or without reason and without prejudice to further treatment. In all cases of withdrawal 
or discontinuation, the Investigator will make all reasonable efforts to determine the reason 
for the subject’s withdrawal. Subjects may be discontinued from the study for the various 
reasons, such as: 
• 
Withdrawal of consent; 
• 
A safety concern defined by the Principal Investigator and/or BSN (e.g., adverse 
event); 
• 
Study non-compliance; 
• 
Subject did not meet inclusion criteria or met an exclusion criteria after signing 
informed consent; 
• 
Subjects not agreeing to a recommended revision; 
• 
Lost to follow-up; 
• 
Death of the subject. 
All applicable case report forms (CRFs) up to the point of subject withdrawal and an “End of 
Study” form must be completed. Any subject deemed “lost to follow-up” should have a 
minimum of three documented attempts to contact him/her prior to completion of the “End of 
Study” form.  
Additional data may no longer be collected after the point at which a subject has been 
withdrawn from the study or withdraws consent, for whatever reason. All open adverse 
events should be closed or documented as unresolved. Data collected up to the point of 
subject withdrawal may be used and analyzed. 

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Subjects withdrawn after a successful implant will not be replaced and will be included in the 
site’s overall total for trialed subjects.  
10.3. Subject Status and Classification 
Subjects who provide written informed consent but do not meet all of the study eligibility 
criteria will not be implanted. These subjects will be deemed as “enrolled but not implanted” 
and their reason for ineligibility will be documented in the EDC system. Enrolled subjects 
who are not implanted will not count towards the enrollment cap.  
Subjects who sign consent, meet all eligibility criteria, and are implanted cannot be replaced. 
10.4. Enrollment Controls 
The overall enrollment in the study will be capped at 60 implanted subjects. Per site 
enrollment will be capped initially at 10 implanted subjects. The initial cap of 10 implanted 
subjects at any one site can be increased based upon written communication of sponsor 
approval. 
The study will implement a formal Enrollment Communication Plan. The plan will outline 
the specific activities, as well as the nature and timing of communications to investigators in 
order to minimize the risk of enrollment beyond the protocol-specified enrollment caps 
determined by the statistical analysis plan. 
 
10.5. End-of-Study Action Plan 
The End-of-Study Action Plan (ESAP) defines the actions to be taken when a subject reaches 
the end of their study participation. At the time of subject withdrawal or during the last study 
follow-up visit the ESAP will be implemented.  
All ESAP decisions made by a subject need to be documented in the subject’s source 
documents.  
When each enrolled subject completes the study, or withdraws, the subject exits the study. If 
the subject is implanted, the subject may continue to use the system per the applicable 
Directions for Use and should be followed according to standard, routine medical care. 
11. Study Methods 
11.1. Data Collection 
There are a number of different study assessments required at each visit. The data collection 
schedule is provided in Table 11-1. Full descriptions for all assessments are provided in 
Section Error! Reference source not found.. 
 

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Table 11-1: Data Collection Schedule 
 
 

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11.2. Screening Period (Up to 60 days following Informed Consent) 
All interested patients will undergo a screening period during which their eligibility into the 
study will be determined.  
Written Informed Consent must be obtained for all subjects who are potential study 
candidates. A subject is considered enrolled only after the subject signs and dates the ICF: 
• Subjects will be asked to sign the Informed Consent form before any study-specific 
tests or procedures are performed;  
• The context of the study must be fully explained and the subjects must be given the 
opportunity to ask questions and have those questions answered to their satisfaction;  
• Study personnel should explain that even if a subject agrees to participate in the study 
and signs an ICF, certain procedures might demonstrate that the patient is not eligible 
to continue participation;  
• The Informed Consent form is study-specific and must be approved by the Ethics 
Committee (EC). 
During the Screening period, eligibility criteria as described in Sections 9.2 and 9.3 will be 
evaluated. If a subject fails study eligibility, they will be withdrawn from the study.  
Subjects will complete a 7-day daily diary (consecutive) to document their pain scores and 
return the diary to the site staff at the Baseline Visit. This diary may be completed in a 15-
day window prior to the Baseline Visit.  
11.3. Baseline Visit (Medication Lock)  
During the Baseline Visit, a detailed evaluation of subjects’ disease state and its impact on 
their health will be performed. Subjects will be asked about any adverse events since their 
last study visit (if any). Subjects will return their completed diary to the site staff. 
 
The following assessments will be completed at the Baseline Visit to obtain baseline 
information on subjects:  
• Pain Intensity: Numerical Rating Scale (NRS) as evaluated by study personnel 
interview  
• Oswestry Disability Index version 2.1a (ODI v2.1a) 
• Resource Utilization Inventory (RUI) 
• Short Form Health Survey 36 items (SF-36 v2) 
• 7-day Subject Diary 
Subject’s opioid medications will be locked at this visit and remain unchanged (no change 
type/dose/route) up to 3-month post Activation Visit.  
 

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End of Visit Information:  
Subjects should be reminded not to make any changes to their opioid medications 
(type/dose/route). 
11.4. SCS Implant Procedure (s) 
Subjects will have up to 45 days to receive their Precision SCS Implant after the Baseline 
visit. Subjects will undergo a screening trial and implant procedure based on the sites’ 
standard of care.  
• Information related to the procedure, devices, etc. will be documented.  
• Only BSC percutaneous leads may be used. Surgical/Paddle leads may not be used. 
• Intraoperative Testing may be performed per standard of care 
• The IPG may be programmed but, following the completion of programming, the 
device will be OFF until the Device Activation Visit 
• The use of acute opioid pain medication for procedural discomfort is allowed, per 
site’s routine care. 
 
End of Visit Information: Following the implant procedure, instructions related 
to follow up care will be provided per standard of care.  
• Subjects are to contact the site in an event that any additional intervention is 
warranted, to report a suspected adverse event, etc.  
• Subjects should be reminded not to make any changes to their opioid medications 
(type/dose/route) 
• If device implantation is unsuccessful, subjects will be followed for 2 weeks post 
implantation in an attempt to assess for procedure related adverse events, if they 
occur. These subjects will be withdrawn from the study. 
11.5. Device Activation Visit 
At the Device Activation Visit, subjects will be programmed at high rate settings for optimal 
therapy. Subjects will be asked about any adverse events since their last study visit (if any). 
Information related to programming will be collected. Subjects may have as many visits as 
needed to obtain optimal programming settings.  
 
End of Visit Information:  
• Subjects should be reminded not to make any changes to their opioid medications 
(type/dose/route); 
• Instructions related to charging and use of device should be provided per standard of 
care. 

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11.6. Programming Visit (45 ± 7 days post-Activation Visit) 
At the Programming Visit, subjects’ device will be programmed to receive optimal settings. 
Subjects will be asked about any adverse events since their last study visit (if any). 
Information related to programming will be collected. 
 
End of Visit Information:  
• Subjects should be reminded not to make any changes to their opioid medications 
(type/dose/route); 
• Instructions related to charging and use of device should be provided per standard of 
care; 
• Subjects will receive a 7-day diary to be completed prior to the 3-Month Visit. The 
diary may be completed in a 15-day window prior to the Visit.  
11.7. 3-Month Visit (90 ± 14 days post-Activation Visit) 
At the 3-Month Visit, subjects’ will return to the clinic for programming and evaluation. 
Subjects will be asked about any adverse events since their last study visit (if any). Subjects 
will return their 7-day diary to the site staff. 
 
The following assessments will be completed at 3-Month Visit prior to device programming.  
• Pain Intensity: Numerical Rating Scale (NRS) as evaluated by study personnel 
interview  
• Percent Pain Relief (PPR) 
• Patient Global Impression of Change (PGI-C) 
• Oswestry Disability Index version 2.1a (ODI v2.1a) 
• Resource Utilization Inventory (RUI) 
• Short Form Health Survey 36 items (SF-36 v2) 
• 7-day Subject Diary 
Per standard of care, subjects’ device may be programmed as needed after completion of 
assessments. Information related to programming will be collected. Subjects’ opioid 
medications may be adjusted as needed and change during the rest of the course of the study. 
Changes to opioid medications should be documented.  
 
End of Visit Information:  
• Instructions related to charging and use of device should be provided per standard of 
care. 

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11.8. 6-Month Visit (180 ± 30 days post-Activation Visit) 
At the 6-Month Visit, subjects’ will return to the clinic for programming and evaluation. 
Subjects will be asked about any adverse events since their last study visit (if any). 
The following assessments will be completed at 12-Month Visit prior to device 
programming.  
• Pain Intensity: Numerical Rating Scale (NRS) as evaluated by study personnel 
interview  
• Percent Pain Relief (PPR) 
• Patient Global Impression of Change (PGI-C) 
• Oswestry Disability Index version 2.1a (ODI v2.1a) 
• Resource Utilization Inventory (RUI) 
• Short Form Health Survey 36 items (SF-36 v2) 
Per standard of care, subjects’ device may be programmed as needed after completion of 
assessments. Information related to programming will be collected. Subjects’ opioid 
medications may be adjusted as needed and change during the rest of the course of the study. 
Changes to opioid medications should be documented.  
 
End of Visit Information:  
• Instructions related to charging and use of device should be provided per standard of 
care; 
• Subjects will receive a 7-day diary to be completed prior to the 12-Month Visit. The 
diary may be completed in a 15-day window prior to the Visit.  
 
11.9. 12-Month Visit (365 ± 30 days post-Activation Visit) - End of Study 
At the 12-Month Visit, subjects’ will return to the clinic for programming and evaluation. 
Subjects will be asked about any adverse events since their last study visit (if any). This Visit 
will be End of Study Visit and subjects will be followed per End of Study Action Plan as 
described in Section 10.5. Subjects will return their 7-day diary to the site staff. 
 
The following assessments will be completed at 12-Month Visit prior to device 
programming.  
• Pain Intensity: Numerical Rating Scale (NRS) as evaluated by study personnel 
interview  
• Percent Pain Relief (PPR) 
• Patient Global Impression of Change (PGI-C) 

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• Short Form Health Survey 36 items (SF-36 v2) 
• Resource Utilization Inventory (RUI) 
• Oswestry Disability Index version 2.1a (ODI v2.1a) 
• 7-day Subject Diary 
Per standard of care, subjects’ device may be programmed as needed after completion of 
assessments. Information related to programming will be collected. Subjects’ opioid 
medications may be adjusted as needed and change during the rest of the course of the study. 
Changes to opioid medications should be documented.  
 
End of Visit Information:  
• Instructions related to charging and use of device should be provided per standard of 
care. 
11.10. 
Unscheduled Study Visits 
Subjects may have as many unscheduled study visits as needed for programming (e.g., 
reprogramming, replacement, revision) or evaluation of adverse events.  
11.11. 
Revision or Replacement of Leads, Extensions and/or IPGs 
During the course of the study, it is possible that leads may be placed incorrectly, migrate, or 
malfunction and require repositioning or replacement. It is also possible that the extensions 
or splitters or IPG may be uncomfortable or malfunction and may require repositioning or 
replacement. The decision to reposition or replace any device component will be made by the 
investigator and only if the subject agrees. Subjects not agreeing to a recommended lead 
revision will be withdrawn from the study but will be included in the intent-to-treat and 
safety analyses. Subjects agreeing to revision will continue on study and will be followed 
according to the original study schedule. Effectiveness data from these subjects will be 
included in the intent to treat analysis. Any replacements or revisions performed during the 
course of the study must be documented. Acute opioid pain medications may be taken per 
standard of care. 
11.12. 
Study Completion 
All subjects permanently implanted with an IPG will be followed through completion of the 
End of Study visit (12-months post-Activation Visit). The End of Study Action Plan (see 
Section 10.5) defines the actions to be taken when the subject reaches the end of their study 
participation.  
11.13. 
Source Documents 
Where copies of the original source document as well as printouts of original electronic 
source documents are retained, these shall be signed and dated by a member of the 

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investigation center team with a statement that it is a true reproduction of the original source 
document. 
  
Table 11-2: Source Documentation Requirements 
Requirement 
Disposition 
Hospital records and/or clinical and office charts 
including the evidence of but not limited to 
inclusion/exclusion criteria, informed consent, 
procedures, laboratory results, medications, 
assessment of adverse events, health resource 
utilization information  
Retained at investigational site 
Imaging films/prints documenting lead(s) 
location  
Retained at investigational site 
Assessments and questionnaires  
Retained at investigational site and/or 
electronic data collection platform / EDC 
Clinician programmer printouts/electronic files 
for programming information 
Retained at investigational site 
 
12. Statistical Considerations 
12.1. Primary Endpoint 
The primary endpoint for this study is low back responder rate at 3 months post-activation, 
based on ≥30% reduction from Baseline in average low back pain without change in opioids. 
Average low back pain will be based on the 0-10 Numerical Pain Rating Scale (NRS) as 
evaluated based on study personnel interview. Opioids will be calculated for each subject 
based on Concomitant Medications at each visit, an ongoing daily capture of all pain-related 
prescriptions.  
Opioid prescription dose will be calculated as mean morphine-equivalent mg based on the 
method described by McPherson with a 3:1 morphine:methadone conversion (Mcpherson 
2009).  
12.1.1. Hypotheses 
The primary statistical hypothesis in this study is that the proportion of low back pain 
intensity responders at 3 months post-activation is superior to the responder rate of 0.20, set 
as the Objective Performance Criterion (OPC) for this study: 

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H0: π ≤ 0.20 
H1: π > 0.20 
12.1.2. Sample Size  
The required sample size for this study was calculated based on the following assumptions: 
Test significance level () 
0.025 
1 or 2 sided test                            
1 
Π 
0.40      
OPC 
0.20  
Power (1- β) 
0.90 
Attrition (%) 
10 
N 
60 
12.1.3. Statistical Methods 
For the primary endpoint, statistical testing will be performed to determine if the low back 
pain responder rate with HR-SCS is superior to the OPC of this study.  
The statistical test will be a Fisher’s Exact test for a single proportion.  
12.2. Secondary Endpoints 
The following secondary endpoints will be analyzed. Assessments required for deriving each 
endpoint are denoted in parentheses. 
• Change in average low back pain from Baseline to 3 months post-Activation (NRS) 
• Change in average leg pain from Baseline to 3 months post-Activation (NRS) 
• Percent pain relief of low back pain at 3 months post-Activation (PPR) 
• Percent pain relief of leg pain at 3 months post-Activation (PPR) 
• Change in low back pain with activity from Baseline to 3 months post-Activation (NRS) 
• Change in leg pain with activity from Baseline to 3 months post-Activation (NRS) 
• Patient global impression of change at 3 months post-Activation (PGI-C) 
• Change in disability from Baseline to 3 months post-Activation (ODI v2.1a) 
• Change in quality of life from Baseline to 3 months post-Activation (SF-36v2) 

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The details of hypothesis and testing methods will be provided in the Statistical Analysis 
Plan (SAP). 
12.3. Exploratory Endpoints 
A number of exploratory endpoints are included in this study to explore the effect of 
treatment on additional outcomes.  
The exploratory endpoints are intended to generate hypotheses for future study. 
Consequently, no correction for multiple testing will be performed for the exploratory 
endpoints. All exploratory endpoints will be clearly identified as such in study reports. 
12.4. Health Economic Endpoints 
A number of health economic endpoints are included in this study to measure the economic 
value of the treatment.  
Full detail regarding analysis of the health economic endpoints will be provided in a separate 
analysis plan. 
12.5. Safety Parameters 
Safety parameters include the Rate of occurrence of all device or procedure related adverse 
events (AEs), SAEs including serious adverse device events (SADEs), unanticipated serious 
adverse device effects (USADEs) through end of study.  
For time-to-event variables, Kaplan-Meier plots will be provided. The Cox proportional 
hazards regression model will be used to assess the effects of risk factors on the time-to-
event variables. 
12.6. Analysis Sets 
All primary and secondary endpoints will be analyzed on both intent-to-treat and a per-
protocol basis.  
Full definitions of the analysis set will be provided in the Statistical Analysis Plan.  
12.6.1. Safety Analysis Set 
In the safety analysis, all subjects who sign the IRB-approved written Informed Consent form 
will be included.  
12.7. Control of Systematic Error/Bias 
Selection of patients will be made from the Investigator's usual patient load. All patients 
meeting the inclusion/exclusion criteria and having signed the Informed Consent Form will 
be eligible for participation in the study. The reasons for exclusion, for subjects who sign an 
informed consent form but are not implanted, will be indicated in EDC. Consequently, 
consecutively eligible subjects will be randomly allocated into the study, minimizing 

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selection bias. Boston Scientific will report to the ethic committee any evidence of fraud, 
including deliberate tampering with the selection of subjects. 
12.8. Number of Subjects per Investigative Site 
In order to enroll up to 60 subjects, up to 10 investigative sites will be included. The number 
of subjects at each site will capped at 10 subjects per site. Sponsor approval must be obtained 
in writing to enroll beyond the site-specific cap of 10 subjects. 
12.9. Eligibility of Subjects, Exclusions, and Missing Data 
All subjects who are enrolled will be eligible for evaluation. Sensitivity analyses will be 
conducted to assess the impact of different assumptions on the interpretation of the results. 
For continuous covariates, the missing/unknown values will be imputed using the mean of 
the pooled observed data. For categorical covariates, the missing/unknown values will be 
combined with the category with the most subjects if the missing/unknown rate is ≤2% of the 
pooled observed data, or they will be classified into a separate category if the 
missing/unknown rate is >2% of the pooled data. If the covariates are also used as subgroup 
variables, the imputed values of subgroup variables will not be used for subgroup 
categorization. 
Primary imputation will be introduced as a sensitivity analysis based on relevant covariates: 
1. If there are observations before and after the missing response, take the 
average of the two neighboring responses to obtain the imputed value. 
2. If there is no observation before the missing response, apply last 
observation carried backward. Missing baseline will not be imputed. 
3. If there is no observation after the missing response, apply the worst case 
scenario on the subject level. 
4. Baseline will not be used to impute missing post-baseline response. 
More details will be provided in Statistical Analysis Plan. 
12.10. 
Data Analyses 
All statistical analyses will be done using the SAS System software, version 8.2 or later 
(Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, 
USA. All rights reserved). Additional details on these analyses can be found in the Statistical 
Analysis Plan. 
12.10.1. 
Interim Analyses  
This study will have a total of 2 looks, with one interim analysis at: 
• 36 subjects at 3 months post-Activation: futility and efficacy stopping 
• Up to 60 subjects at 3 months post-Activation: futility and efficacy stopping 

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The adaptive design will use the Lan-DeMets group sequential method (Lan and DeMets 
1983) with the O’Brien-Flemming α-spending function (O'Brien and Fleming 1979) and 
Pocock β-spending function (Pocock 1977). Details regarding the futility and efficacy 
boundaries will be provided in the Statistical Analysis Plan.  
All interim analysis decision will proceed according to pre-specified decision rules, detailed 
in the Statistical Analysis Plan. 
12.10.2. 
Subgroup Analyses 
Results will be summarized for the following subgroups: 
• Primary pain etiology (FBSS, CRPS, Radiculopathy, Other)  
• Opioid user (Yes/No) 
• Gender (male, female, intersex) 
• Number of back surgeries (0 vs. 1 or more) 
• Primary Pain Diagnosis 
• Study region or center 
12.10.3. 
Justification of Pooling 
Analyses will be performed using data pooled across various sites/institutions. Multivariate 
analysis techniques, including contingency tables and logistic regression for binary outcomes 
and analysis of variance for continuous measures, will be used to assess differences among 
study sites to justify pooling data across sites. 
12.10.4. 
Multivariable Analyses 
Multivariate analyses will be performed to assess the effect of possible covariates on the 
primary endpoint. All covariates will be modeled multivariately using an appropriate 
regression model. The following variables will be included as potential covariates: 
• Age  
• Baseline low back pain intensity  
• Baseline leg pain intensity 
• Baseline Visit ODI score  
• Duration of low back pain 
• Duration of leg pain 
• Number of back surgeries  
• Opioid use  

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12.11. 
Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan approved prior to performing the 
analyses. Changes from the planned statistical methods after performing the analyses will be 
documented in the clinical study report along with a reason for the deviation. 
13. Data Management 
13.1. Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by Medidata. All changes 
made to the clinical data will be captured in an electronic audit trail and available for review 
by Boston Scientific Corporation (BSC) or its representative. The associated RAVE software 
and database have been designed to meet regulatory compliance for deployment as part of a 
validated system compliant with laws and regulations applicable to the conduct of clinical 
studies pertaining to the use of electronic records and signatures. Database backups are 
performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the EDC system and will 
be issued to the site for appropriate response. Site staff will be responsible for resolving all 
queries in the database. 
13.1.1. Electronic Questionnaires 
Questionnaires in electronic form may be collected directly using an electronic data 
collection platform at the clinical site (e.g. iPad). After completion by the subject or a 
clinician, data from the electronic questionnaires are transmitted directly into the EDC 
system. 
13.1.2. Direct Data Upload 
For quality assurance purposes and validation, technical data on the SCS device, stored in the 
BSC Field Clinical Engineer/Field Clinical Specialist’s (FCE) Clinician Programmer, will be 
collected using direct data upload to a secure BSC server. BSC FCEs, who assist in 
programming the device settings per routine care, will upload the Clinician Programmer 
database files to a secure server stored in a restricted location at BSC. 

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13.2. Study Assessments 
13.2.1. Adverse Events 
Adverse event evaluation will be conducted to identify adverse events occurring during the 
study and classify them in regards to seriousness, relationship to the study procedure and/or 
device, action taken and outcome.  
13.2.2. Concomitant Medications 
All prescribed pain-related medications will be collected throughout the study in order to 
obtain a full record of medication-related resource utilization. Information will include 
medication name, dates of prescription, indication or purpose, dose, frequency, and route of 
administration. 
13.2.3. Demography 
Demographic information will include birth year, birth day and month (if allowed by local 
regulations), gender, and race/ethnicity.  
13.2.4. Pain Diary (Diary) 
The Pain Diary is a paper based questionnaire assessing the daily intensity of the subject’s 
average low back and leg pain. Pain is measured daily on a 0 – 10 numerical rating scale 
(NRS), where 0 indicates “no pain” and 10 indicates “worst pain imaginable”.  
13.2.5. Medical History 
Medical history will include medical and procedural history relating to pain management, 
onset of chronic pain, and all pain-related diagnoses.  
13.2.6. Oswestry Disability Index version 2.1a (ODI v2.1a) 
ODI v2.1a assesses the degree of subject disability due to pain, measuring the impact of pain 
on activities of daily living. ODI v2.1a is composed of 10 questions that describe the pain 
and its impact on daily life on a 0-5 scale, with higher values indicating the more severe 
impact. 
13.2.7. Numerical Rating Scale (NRS) 
Pain Intensity is a questionnaire that assesses the intensity of the subject’s leg pain and low 
back pain over the past 7 days based on study staff interview. Pain intensity is expressed on a 
0 – 10 numerical rating scale (NRS), where 0 indicates “no pain” and 10 indicates “pain as 
bad as you can imagine”. The questionnaire assesses pain intensity separately for the 
subject’s average daily leg pain intensity and average daily low back pain intensity. 

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13.2.8. Patient Global Impression of Change (PGI-C) 
PGI-C is a seven-point scale that requires the subject to assess how much their condition has 
improved or worsened relative to their baseline. Subjects will rate themselves as: very much 
improved; much improved; minimally improved; no change; minimally worse; much worse; 
or very much worse. 
13.2.9. Percent Pain Relief (PPR) 
PPR is a questionnaire assessing how much of the subject’s low back pain and leg pain has 
been relieved by the SCS treatment. Pain relief is expressed as a percentage from 0 – 100%. 
13.2.10. Procedure Information 
General information will be collected regarding the SCS procedures performed during the 
study, including implant, explant, and revision procedures.  
13.2.11 Programming Parameters 
Standard information regarding the programming parameters used to program the subject’s 
IPG, as well as measurements taken using the device (e.g. contact impedances) will be 
collected from the Clinician Programmer (CP).  
13.2.12 Resource Utilization Inventory (RUI) 
Health-related resource utilization data will be collected to support the health economic 
analyses. Resource utilization categories include: office/hospital visits, diagnostic tests, and 
non-surgical procedures.  
13.2.13 SF-36v2 Health Survey (SF-36v2) 
The SF-36v2 measures subjects’ functional health and well-being from their own point of 
view. SF-36v2 is comprised of 36 questions spanning eight health domains: physical 
functioning, role-physical, bodily pain, general health, vitality, social functioning, role-
emotional, and mental health. All health domain scales contribute to the scoring of two 
component summary measures: physical health and mental health. 
 
13.3 
Data Retention 
The Investigator or Investigational site will maintain, at the investigative site, in original 
format all essential study documents and source documentation that support the data 
collected on the study subjects in compliance with ICH/GCP guidelines. Documents must be 
retained for at least 2 years after the last approval of a marketing application or until at least 2 
years have elapsed since the formal discontinuation of the clinical investigation of the 
product. These documents will be retained for a longer period of time by agreement with 

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BSC or in compliance with other local regulations. It is BSC’s responsibility to inform the 
Investigator when these documents no longer need to be maintained.  
The Investigator will take measures to ensure that these essential documents are not 
accidentally damaged or destroyed. If for any reason the Investigator withdraws 
responsibility for maintaining these essential documents, custody must be transferred to an 
individual who will assume responsibility and BSC must receive written notification of this 
custodial change.  
14 
Amendments  
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals (e.g., 
EC/CA) of the revised protocol must be obtained prior to implementation. 
15 
Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing EC of any deviation from the investigational plan to protect the 
life or physical well-being of a subject in an emergency, and those deviations which affect 
the scientific integrity of the clinical investigation. Such notice shall be given as soon as 
possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using EDC. Sites may also be 
required to report deviations to the EC, per local guidelines and government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, site re-training, or site 
discontinuation/termination) will be put into place by the sponsor. 
16 
Device/Equipment Accountability 
No device accountability will be required, because this study will be using commercially 
available devices. Compliance 
 
 

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17 
Compliance 
17.1 
Statement of Compliance 
This study will be conducted in accordance with ISO 14155: Clinical Investigation of 
Medical Devices for Human Subjects – Good Clinical Practice; 21 CFR Part 812, ethical 
principles that have their origins in the Declaration of Helsinki, and pertinent individual 
country laws and regulations. The study shall not begin until the required approval/favorable 
opinion from the IRB/EC and/or regulatory authority has been obtained, if appropriate. Any 
additional requirements imposed by the IRB/EC or regulatory authority shall be followed, if 
appropriate. 
17.2 
Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigation 
plan, ISO 14155, ethical principles that have their origins in the Declaration of Helsinki, any 
conditions of approval imposed by the reviewing IRB/EC, and prevailing local and/or 
country laws and/or regulations, whichever affords the greater protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   
 
• Prior to beginning the study, sign Protocol Signature page documenting his/her 
agreement to conduct the study in accordance with the protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event as applicable per the protocol and observed device deficiency. 

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• Report to BSC, per the protocol requirements, all SAEs and device deficiencies that 
could have led to a SADE. 
• Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
could have led to a SADE, if required by the national regulations or this protocol or by 
the IRB/EC, and supply BSC with any additional requested information related to the 
safety reporting of a particular event. 
• Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
clinical research monitor or auditor and respond to questions during monitoring visits or 
audit(s). 
• Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local EC requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the device when it is used/operated by the subject. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, as needed. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 

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17.2.1  Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for providing 
appropriate training and adequate supervision of those to whom tasks are delegated. The 
investigator is accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of the clinical study. Only trained, experienced, licensed physicians are 
allowed to perform study procedures (e.g., IPG and Permanent Lead Implantation). 
17.3 
Institutional Review Board/ Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational site will provide to the sponsor 
documentation verifying that their EC is registered or that registration has been submitted to 
the appropriate agency, as applicable according to national/regulatory requirements.   
A copy of the written EC and/or competent authority approval of the protocol (or permission 
to conduct the study) and Informed Consent Form, must be received by the sponsor before 
recruitment of subjects into the study and shipment of investigational product/equipment. 
Prior approval must also be obtained for other materials related to subject recruitment or 
which will be provided to the subject. 
Annual EC approval and renewals will be obtained throughout the duration of the study as 
required by local/country or EC requirements. Copies of the Investigator’s reports and the EC 
continuance of approval must be provided to the sponsor.  
17.4 
Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative including, but not limited to Contract Research Organization (CRO) will have 
access to these confidential records.  
Authorized regulatory personnel have the right to inspect and copy all records pertinent to 
this study. Study data collected during this study may be used by BSC for the purposes of 
this study, publication, and to support future research and/or other business purposes. All 
data used in the analysis and reporting of this study will be without identifiable reference to 
specific subject name. 
Boston Scientific will keep subjects’ identifiable health information confidential in 
accordance with all applicable laws and regulations.  Boston Scientific may use subjects’ 
health information to conduct this research, as well as for additional purposes, such as 
overseeing and improving the performance of its device, new medical research and proposals 
for developing new medical products or procedures, and other business purposes. 
Information received during the study will not be used to market to subjects; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes.  

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17.4.1  Role of Field Clinical Engineer/Field Clinical Specialist 
Boston Scientific personnel, including the Field Clinical Engineer/Field Clinical Specialist 
(FCE/FCS)or qualified designate can provide technical support to the investigator and other 
health care personnel (collectively HCP) as needed during implant, testing and programming 
required by the protocol, and follow-ups. Support may include HCP training, addressing 
HCP questions, or providing clarifications to HCPs concerning the operation of BSC 
equipment/devices (including programmers and other support equipment). 
At the request of the investigator and while under investigator supervision, BSC personnel 
may operate equipment during implant or follow-up, assist with the conduct of testing 
specified in the protocol, and interact with the subject to accomplish requested activities.  
Typical tasks may include the following. 
• Interrogating the device or programming device parameters to investigator-requested 
settings as specified in the protocol as well as operating investigational equipment 
• Performing device testing using a programmer to obtain thresholds and impedance 
measurements 
• Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel 
• Assisting with the collection of study data from programmers and other equipment 
• Entering technical data on technical source form as long as the responsible HCP verifies 
and signs the completed worksheet  
• Print out programming reports directly from the clinician programmer and provide 
original to clinical site as source documentation 
• Provide technical expertise/support to subjects during office visits and/or during 
teleconference calls with the principal investigator or their delegated site staff and the 
subject.  
In addition, BSC personnel may perform certain activities to promote study quality. These 
activities may include the following. 
• Observing testing or medical procedures to provide information relevant to protocol 
compliance 
• Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following.  
• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject without the approval and 
presence of the HCP 
• Independently collect critical study data (defined as primary or secondary endpoint data) 

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• Enter data in electronic data capture systems or on paper case report forms 
 
17.5 
Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
18 
Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the clinical research monitor verifies that 
study records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively. The Principal 
Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, and appropriate regulatory authorities. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Principal Investigator 
and relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
19 
Potential Risks and Benefits 
Subjects who take part in this study are subject to similar risks shared by all subjects who 
receive this device but are not participating in this study. In addition, this study is set up to 
collect data through questionnaires and interviews. To complete these additional 
questionnaires and interviews the subject will spend additional time at the hospital and/or 
doctor’s office. They may have an increased number of visits to the hospital and/or doctor’s 
office compared to standard of care.  
 
19.1 
Risks Associated with the Commercial Device(s)  
There are no known incremental risks associated with use of the commercial device within 
this study setting.  
19.2 
Risks associated with Participation in the Clinical Study 
The subject might find it difficult, uncomfortable, or tiresome to complete study visits, diary, 
and/or questionnaires. They may be uncomfortable with the medication lock requirements. 

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19.3 
Possible Interactions with Concomitant Medical Treatments 
No possible interactions have been identified for use of the SCS system concomitant with 
any specific medications. However, there may be some risk that is unknown. 
Please refer to the Directions for Use Manual for procedures that should not be used while 
the SCS lead/s remains implanted. 
19.4 
Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
The PRECISION Spinal Cord Stimulation System with MultiWave Technology is indicated 
as an aid in the management of chronic intractable pain. Based on clinical and post-market 
experience, the anticipated risks associated with the use of the PRECISION™ system are 
predicted to be acceptable compared to the expected benefits in the reduction of symptoms. 
The treatment is reversible in that the device may be turned off or explanted at any time for 
any reason. 
All efforts will be made to minimize the aforementioned potential risks using the following 
approaches: 
• 
Selection of Investigators (anesthesiologists and neurosurgeons) who are 
experienced and skilled in the treatment of subjects as per BSC’s site selection 
and qualification procedures 
• 
Clearly defined inclusion and exclusion criteria that ensure only appropriate 
subjects are enrolled 
• 
Ensuring that treatment and follow-up of subjects is consistent with current 
medical practice 
• 
Safety review processes by Boston Scientific 
• 
Monitoring visits 
 
19.5 
Anticipated Benefits 
The reported benefit of the PRECISION SCS System with MultiWave Technology may 
include: 
• Reduction in the intensity of chronic low back pain 
• Reduction in the intensity of chronic leg pain 
• Improvement in physical functioning (disability) 

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• Reduction in pain-related medication use  
• Reduction in the occurrence of side-effects of pain-related medications accompanied 
by reduction in opioid use (e.g. sleep disturbances, constipation, reduction in mental 
acuity) 
 
19.6 
Risk to Benefit Rationale 
The risk evaluation for the PRECISION SCS System with MultiWave Technology 
determined that all hazards attributed to the PRECISION SCS System with MultiWave 
Technology and overall remaining residual risks after implementations of the required 
mitigations have been evaluated. Based on the risk evaluation results, the benefit provided by 
the PRECISION SCS System with MultiWave Technology to treat chronic intractable pain 
outweighs the remaining residual risk. As the overall residual risk meets BSN’s criteria, the 
PRECISION SCS System with MultiWave Technology is acceptable for use in a clinical 
setting. 
19.7 
Warnings and Precautions 
To avoid possible complications, be sure to review warnings and precautions section of the 
Directions for Use Manuals. 
 
20 
Safety Reporting 
 
20.1 
Definitions and Classification 
Adverse event definitions are provided in Error! Reference source not found..  
 
 
Table 20-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, whether or not related to the investigational 
medical device.  
NOTE 1: This includes events related to the investigational medical device 
or comparator. 
NOTE 2: This definition includes events related to the procedures involved 
(any procedure in the clinical investigation plan). 
NOTE 3: For users or other persons, this definition is restricted to events 

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Table 20-1: Safety Definitions 
Term 
Definition 
related to the investigational medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event related to the use of an investigational medical device 
NOTE 1: This definition includes any adverse event resulting from 
insufficient or inadequate instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the investigational medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event that: 
a) Led to death, 
b) Led to serious deterioration in the health of the subject, that either 
resulted in: 
a life-threatening illness or injury, or 
a permanent impairment of a body structure or a body function, or 
in-patient or prolonged hospitalization of existing hospitalization, or 
medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function 
c) Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
 
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the risk analysis 
report. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect 
which by its nature, incidence, severity or outcome has been identified in the 
risk analysis report. 
Device Deficiency 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
A device deficiency is any inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. 
NOTE 1: Device deficiencies include malfunctions, misuse or use errors, 
and inadequate labeling. 
 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the investigation. Death should not be recorded as an AE, but 
should only be reflected as an outcome of a specific SAE (see Table 20-1 for AE definitions).  

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Any AE experienced by the subject after informed consent, whether during or subsequent to 
the procedure, must be recorded in the eCRF. 
Refer to Section 19 for the known risks associated with the device(s). 
NOTES: 
1. For the purposes of this study, hospitalization is defined as any in-patient admission.  
2. Hospitalizations occurring for the purpose of performing a planned procedure as per 
routine care such as implant procedures, or follow-up visits, are not to be reported as 
a SAE. However, complications or adverse events that occur during the planned 
procedure should be reported as (S)AEs if they meet the protocol specified 
definitions.  
3. Elective/planned hospitalization(s) need not be reported as an SAE. However, 
complications or adverse events that occur during an elective/planned hospitalization, 
should be reported as (S)AEs if they meet the protocol specified definitions.  
4. In the event of subject death during the conduct of the study, efforts should be made 
to perform an autopsy.  
5. Sensations or side effects that occur during the programming session should not be 
reported as AEs. However, undesired sensations or side effects caused by the final 
programming parameters (including active contact, pulse width, frequency, and 
amplitude) that persist or occur after the completion of the programming should be 
reported as AEs. 
6. Lack of efficacy/decreased therapeutic response should not be reported as AEs. 
Clinical sequelae, other than pain, that occur as a result of lack of efficacy/decreased 
therapeutic response should be reported as AEs 
7. Clinically significant worsening of the pattern of intensity or distribution of Baseline 
pain symptoms should be reported as an AE.  
8. Device deficiencies, including, but not limited to device/lead migrations, which are 
not associated with an adverse clinical outcome should only be reported as device 
deficiencies. However, if a device deficiency precipitates an AE, the AE should be 
reported in the Adverse Event eCRF and the device deficiency should be documented 
in the Device Deficiency eCRF.  
 
 
 
 
 
 

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20.2 
Relationship to Study Device(s) 
The Investigator must assess the relationship of the AE to the study device or procedure. See 
criteria in Error! Reference source not found. 
 
Table 20-2: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 
Classification 
Description 
Unrelated 
The adverse event is determined to be due to a concurrent illness or effect of another 
device/drug and is not related to the investigational product. 
Related 
d) The adverse event is determined to be potentially related to the investigational 
product, and an alternative etiology is equally or less likely compared to the 
potential relationship to investigational product, or 
e) There is a strong relationship to investigational product, or recurs on re-challenge, 
and another etiology is unlikely, or 
There is no other reasonable medical explanation for the event. 
The Investigator must assess the potential relationship of all adverse events to the device and 
procedure. All device related adverse events will be assessed according to their relationship 
to one of the following sub-categories: 
• Device Hardware-Related AEs: AEs that can reasonably be attributed to the mere 
physical presence of the device or to deficiency of the device (i.e., an allergic 
response to device materials).  
• Stimulation-Related AEs: AEs that can reasonably be attributed to the effects of 
stimulation. A relationship to stimulation may be determined by demonstrating a 
predictable response to the alternating between stimulation-on and stimulation-off 
settings. However, a relationship to stimulation may also be reported without 
demonstrating a predictable response to the alternating between the stimulation-on 
and stimulation-off settings if in the opinion of the Investigator the AE is potentially 
related to stimulation.  
• Procedure Related AEs: AEs that can reasonably be attributed to a study protocol 
required procedure. 
 
20.3 
Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Error! Reference s
ource not found.3. 
 
Table 20-3: Investigator Reporting Requirements 
Unanticipated Serious Adverse 
Device Effect  
Complete AE eCRF page with all 
available new and updated information 
• Within 1 business day of first 
becoming aware of the event. 
• Terminating at the end of the 
study 

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Table 20-3: Investigator Reporting Requirements 
Serious Adverse Event 
including Serious Adverse 
Device Effects 
Complete AE eCRF page with all 
available new and updated information 
• Within 2 business days of first 
becoming aware of the event or 
as per local/regional regulations. 
• Reporting required through the 
end of the study 
Provide all relevant source 
documentation (unidentified) for 
reported event 
• When documentation is 
available 
Adverse Event 
Complete AE eCRF page, which 
contains such information as date of 
AE, treatment of AE resolution, 
assessment of seriousness and 
relationship to the device 
• In a timely manner (e.g. 
Recommend within 10 business 
days) after becoming aware of 
the information 
• Reporting required for adverse 
events related to procedure, 
hardware and stimulation. 
• Reporting is required through 
the end of the study.  
 
Device Deficiencies (including 
but not limited to failures, 
malfunctions, and product 
nonconformities) 
Note: Any Investigational 
Device Deficiency that might 
have led to a serious adverse 
event if a) suitable action had 
not been taken or b) 
intervention had not been 
made or c) if circumstances 
had been less fortunate is 
considered a reportable event. 
 
Complete Device Deficiency eCRF 
with all available new and updated 
information 
• Within 2 business day of first 
becoming aware of the event 
and as per local/regional 
regulations 
• Reporting required through the 
end of the study 
 
Note: 
• AEs related to device/procedure, SAEs, SADEs, Device Deficiencies and USADEs 
will be collected from the time of informed consent through end of study. SAEs and 
Device Deficiencies may be reported via phone, fax or email if the electronic data 
capture (EDC) system is unavailable. The paper SAE Notification Form or Device 
Deficiency Notification Form should be used to report SAEs and/or device 
deficiencies during this time.  
• Subjects should be instructed to contact their physician immediately if they 
experience any adverse event rather than wait for a scheduled visit. 

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20.4 
Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and labeling errors) will be documented and reported to BSC. If 
possible, the device(s) should be returned to BSC for analysis. Instructions for returning the 
investigational device(s) will be provided. If it is not possible to return the device, the 
investigator should document why the device was not returned and the final disposition of the 
device. Device failures and malfunctions should also be documented in the subject’s medical 
record. 
Boston Scientific will be notified of all device deficiencies, failures, malfunctions and 
product nonconformities with respects to the products in use in the study. Report all these 
events in the appropriate eCRF.  
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not to be reported as adverse events. However, if there is an adverse 
event that results from a device failure or malfunction, that specific event would be recorded 
on the appropriate eCRF. 
And, any Investigational Device Deficiency that might have led to a serious adverse event if 
a) suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate is considered a reportable event. 
20.5 
Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
BSC is responsible for reporting adverse event information to all participating Principal 
Investigators and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the EC, and regulatory authorities of 
UADE and SAE as required by local/regional regulations. 
 
21 
Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
each subject or his/her legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable. The ICF must be 
accepted by BSC or its delegate (e.g. CRO), and approved by the site’s IRB/EC, or central 
IRB, if applicable. 

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Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s IRB/EC.  Any modification requires acceptance from BSC prior to use of 
the form.  The ICF must be in a language understandable to the subject and if needed, BSC 
will assist the site in obtaining a written consent translation. Translated consent forms must 
also have IRB/EC approval prior to their use.  Privacy language shall be included in the body 
of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the site and a copy of the signed and dated document and any 
other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements (e.g., FDA requirement is within 5 working days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Acceptance by Boston Scientific is required if changes to the revised ICF are 

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requested by the site’s IRB/EC. The IRB/EC will determine the subject population to be re-
consented. 
Study personnel should explain that even if a subject agrees to participate in the study and 
signs an Informed Consent form, screening procedures may demonstrate that the subject is 
not a suitable candidate for the study. 
22 
Committees 
22.1 
Safety Monitoring Process 
To promote early detection of safety issues, the BSC Medical Director will provide 
evaluations of safety events. Success of this program requires dynamic collection of 
unmonitored data as soon as the event is reported. This is expedited through BSC’s Safety 
Office, which is responsible for coordinating the collection of information for the subject 
dossier from the sites. During regularly scheduled monitoring activities, clinical research 
monitors will support the dynamic reporting process through their review of source document 
and other data information.  
23 
Suspension or Termination 
23.1 Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of subjects.  Investigators, associated IRBs/ECs, and regulatory 
authorities, as applicable, will be notified in writing in the event of study termination. 
23.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
• The occurrence of unanticipated adverse device effects that present a significant or 
unreasonable risk to subjects enrolled in the study. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
• A decision on the part of Boston Scientific to suspend or discontinue development of the 
device. 
23.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval 
Any investigator, or IRB/ EC in the VELOCITY Study may discontinue participation in the 
study or withdrawal approval of the study, respectively, with suitable written notice to 

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Boston Scientific. Investigators, associated IRBs/ECs, and regulatory authorities, as 
applicable, will be notified in writing in the event of these occurrences. 
23.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating sites by Boston Scientific. The 
IRB/EC and regulatory authorities, as applicable, will be notified. Detailed information on 
how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB or EC terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by Boston Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible. In the event there are no opportunities 
to transfer Principal Investigator responsibility; detailed information on how enrolled 
subjects will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and 
investigational product to Boston Scientific, unless this action would jeopardize the rights, 
safety, or welfare of the subjects. 
23.4 Criteria for Suspending/Terminating a Study Site 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
center at any time after the study initiation visit if no subjects have been enrolled or if the 
center has multiple or severe protocol violations/noncompliance without justification and/or 
fails to follow remedial actions. 
In the event of termination of site participation, all study devices and testing equipment, as 
applicable, will be returned to BSC unless this action would jeopardize the rights, safety or 
well-being of the subjects. The IRB/EC and regulatory authorities, as applicable, will be 
notified. All subjects enrolled in the study at the site will continue to be followed according 
to the protocol and the end of study action plan. The Principal Investigator at the site must 
make provision for these follow-up visits unless BSC notifies the investigational site 
otherwise. 
The sponsor may also consider transferring active subjects from the site that is being closed 
to another approved study site within geographic area. 
  
Possible reasons for suspending/terminating a study center include: 
• 
Persistent non-compliance with protocol; 
• 
Repeated failure to complete CRFs in a timely manner; 
• 
Failure to obtain written Informed Consent; 

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• 
Failure to report UADE within 1 business day after “becoming aware date” and SAE 
within 2 business days after becoming aware date to BSC; 
• 
Loss of (or unaccounted for) investigational product inventory; 
• 
Failure to enroll subjects. 
24 
Publication Policy 
In accordance with the Corporate Policy on the Conduct of Human Subject Research, BSC 
requires disclosure of its involvement as a sponsor or financial supporter in any publication 
or presentation relating to a BSC study or its results. In accordance with the Corporate Policy 
for the Conduct of Human Subject Research, BSC will submit study results for publication 
(regardless of study outcome) following the conclusion or termination of the study. Boston 
Scientific Corporation adheres to the Contributorship Criteria set forth in the Uniform 
Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed. 
• All authorship and contributorship requirements as described above must be followed. 
• BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
25 
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26 
Abbreviations and Definitions  
Abbreviations are shown in Error! Reference source not found..   
 
Table 26-1: Abbreviations 
Abbreviation/Acronym 
Term 
ADE 
adverse device effect 
AE 
adverse event 
BSC 
Boston Scientific Corporation 
BSN 
Boston Scientific Neuromodulation 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CMM 
conventional medical management 
CP 
clinician programmer 
CR 
conventional rate 
CRC 
clinical research coordinator 
CRF 
Case report form 
CRO 
contract research organization 
CR-SCS 
conventional rate spinal cord stimulation 
DFU 
directions for use 
DSM-IV 
The Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th edition  
EC 
ethics committee 
eCRF 
electronic case report form 
EDC 
electronic data capture 
ESAP 
end of study action plan 
ETS 
external trial stimulator 
FBSS 
failed back surgery syndrome 
FCE 
Field Clinical Engineer/Field Clinical Specialist 
HCP 
health care provider 
HR 
high rate 
HR-SCS 
high rate spinal cord stimulation 
Hz 
hertz 
ICF 
informed consent form 
ICMJE 
International Committee for Medication Journal Editors 
IDE 
investigational device exemption 
IPG 
implantable pulse generator 
ISO 
International Organization for Standardization 
ITT 
intent-to-treat 

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kHz 
kilohertz 
LTTS 
Long-Term Therapy Selection 
mA 
milliamps 
MRI 
magnetic resonance imaging 
NRS 
numerical rating scale 
PGI-C 
Patient Global Impression of Change assessment - see Section 13 for a detailed 
description  
PPR 
percent pain relief 
Programming 
The process of turning on and adjusting the stimulation parameters (amplitude, 
pulse width, rate, polarity) on an implantable pulse generator or external trial 
stimulator to arrive at optimal therapeutic parameters 
PW 
pulse width 
RC 
remote control 
RCT 
randomized controlled trial 
RF 
radio frequency 
RUI 
Resource Utilization Inventory assessment - see Section 13 for a detailed 
description  
SADE 
serious adverse device effect 
SAE 
serious adverse event 
SCS 
spinal cord stimulation 
SF-36v2 
Short Form 36 Health Survey ver 2 - see Section 13 for a detailed description 
Sth 
sensory threshold 
UADE 
unanticipated adverse device effect 
USADE 
unanticipated serious adverse device effect