Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
Phase: NA
Conditions: Chronic Pain
Sponsor: Boston Scientific Corporation

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 1 of 76 
 
 
Focal Pain Outcomes using Configurations Applied for Lateral Stimulation  
 
 
FOCAL 
A4068 
CLINICAL INVESTIGATION PLAN 
 
National Clinical Trial (NCT) Identified Number: NCT04073446 
Sponsored By 
Boston Scientific International S.A. 
Parc Val Saint-Quentin, Bâtiment H 
2 Rue René Caudron 
78960 Voisins le Bretonneux, France 
 
 
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. 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 2 of 76 
 
1 Contact Information 
Role 
Contact  
Clinical Contact 
Elke Sommerijns 
Clinical Project Manager 
Boston Scientific Europe 
Lambroekstraat 5D 
1831 Diegem 
Belgium 
Phone: +32 479 76 71 56 
Email: elke.sommerijns@bsci.com 
R&D Contact 
Jessica Block 
R&D Biomedical Engineer II 
Boston Scientific USA 
25155 Rye Canyon Loop 
Valencia, CA 91355 
USA 
Phone: +1 661 949 4386 
Email: jessica.block@bsci.com  
Coordinating Principal 
Investigator(s) 
Prof. Dr. Jean-Pierre Van Buyten 
AZ Nikolaas 
Moerlandstraat 1 
 9100 Sint-Niklaas 
 Belgium 
Phone:+ 32 3760 2318 
Email: info@drvanbuyten.be  
Coordinating 
Co-Principal 
Investigators 
Dr. Iris Smet  
AZ Nikolaas 
Moerlandstraat 1 
9100 Sint-Niklaas 
Belgium 
Phone:+ 32 3 760 23 18 
Email: iris@drsmet.onmicrosoft.com 
 
Dr. Jan-Willem Kallewaard 
Ziekenhuis Rijnstate 
Wagnerlaan 55 
6815 DD Arnhem 
The Netherlands 
Phone: +31 88 00 55 31 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 3 of 76 
 
Email: jkallewaard@rijnstate.nl 
 
Vendors/Labs 
NA 
 
 
 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 4 of 76 
 
Original Release: January 22, 2019 
Current Version: February 24, 2021 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
A 
22-JAN-2019 
92120219 
Rev/Ver.B 
ALL 
Initial release 
NA 
NA 
B 
26-NOV-2019 
92120219 
Rev/Ver.C 
Cover page 
/ 
National Clinical Trial 
(NCT) Identified 
Number: NCT04073446 
NCT number added 
B 
26-NOV-2019 
92120219 
Rev/Ver.C 
Section 2 (Protocol 
Synopsis); Section 10 
(Subject Selection) 
DC subgroup 
 
 
 
DC/DR subgroup 
 
 
 
Possibility that some 
subjects have DR lead 
coverage only; these 
subjects should have 
the possibility to enter 
the sub-study as well. 
B 
26-NOV-2019 
92120219 
Rev/Ver.C 
Section 2 (Protocol 
Synopsis); Section 10 
(Subject Selection) 
Patients with at least 80% 
pain/paresthesia overlap at 
DC leads only will be part 
of the DC subgroup 
 
Patients with at least 
80% pain/paresthesia 
overlap at DC/DR leads 
only will be part of the 
DC/DR subgroup 
Possibility that some 
subjects have DR lead 
coverage only; these 
subjects should have 
the possibility to enter 
the sub-study as well. 
B 
26-NOV-2019 
92120219  
Rev/Ver.C 
Section 2 (Protocol 
Synopsis), Section 4 
(Introduction), 
Section 6 (Study 
Objectives and 
Endpoints), Section 8 
(Surgical 
Methodology), 
Focal foot pain 
Focal foot or knee pain 
Extend subject 
population to include 
subjects with knee 
pain as well. 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 5 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
Section 9 (Study 
Design), Section 10 
(Subject Selection), 
Section 12 (Study 
Methods) 
B 
26-NOV-2019 
92120219 
Rev/Ver.C 
Section 2 (Protocol 
Synopsis), Section 8 
(Surgical 
Methodology), 
Section 12 (Study 
Methods) 
If the dorsal root leads 
cannot be implanted due to 
patient-specific anatomy or 
other complications, the 
patient will be implanted 
with 2 tightly spaced 
percutaneous leads over the 
thoracolumbar spinal cord 
only and be part of the DC-
group if pain/paresthesia 
overlap is at least 80%. 
 
 
 
 
 
 
 
 
 
 
 
 
 
If the dorsal root lead(s) 
cannot be implanted 
due to patient-specific 
anatomy or other 
complications, the 
patient will be 
implanted with up to 2 
tightly spaced 
percutaneous leads over 
the thoracolumbar 
spinal cord only and be 
part of the DC-group if 
pain/paresthesia 
overlap is at least 80%. 
 
 
Patients with only 
>80% paresthesia 
overlap with DR 
stimulation in the OR 
will proceed with the 
DR-specific 
programming periods. 
No randomization will 
be completed with these 
patients. These patients 
will receive DR 
Up to 2 lumbosacral 
leads can be 
implanted, but this 
isn’t a requirement. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Provide clarification 
on  patients with 
>80% paresthesia 
overlap with DR 
stimulation. 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 6 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
perception based 
stimulation setting for 
approx. 4 ± 1.5 weeks. 
After this, the subject 
will have a washout 
period of up to 7 days 
followed with a DR sub-
perception based 
stimulation for approx. 
6 ± 2 weeks. Lastly, 
patients will enter a 
long term follow up of 
12 weeks where further 
optimizations may be 
done. 
B 
26-NOV-2019 
92120219  
Rev/Ver.C 
Section 8 (Surgical 
Methodology) and 
Section 12 (Study 
Methods) 
Subjects will be implanted 
with 2 tightly spaced 
percutaneous leads placed 
over the thoracolumbar 
spinal cord and 2 additional 
tightly spaced percutaneous 
leads placed adjacent to the 
lumbosacral dorsal nerve 
roots ipsilateral to the 
subject’s foot pain. The 
spatial arrangement of the 4 
leads is shown in Figure 8 1. 
 
Placement of leads adjacent 
to the lumbosacral dorsal 
nerve roots will be via a 
cranio-caudal approach in 
Subjects will be 
implanted with up to 2 
tightly spaced 
percutaneous leads 
placed over the 
thoracolumbar spinal 
cord and up to 2 
additional tightly 
spaced percutaneous 
leads placed adjacent to 
the lumbosacral dorsal 
nerve roots ipsilateral 
to the subject’s foot 
pain. The spatial 
arrangement of the 
leads is shown in Figure 
8 1. 
 
Up to 2 
thoracolumbar and up 
to 2 lumbosacral leads 
can be implanted, but 
this isn’t a 
requirement.  
 
 
 
 
 
 
 
 
 
 
 
 

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Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 7 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
where the SCS lead will be 
inserted at the L1/L2 level 
and navigated caudally 
under fluoroscopic 
guidance. If the dorsal root 
lead(s) cannot be implanted 
due to patient-specific 
anatomy or other 
complications, the patient 
will be implanted with 2 
tightly spaced percutaneous 
leads over the 
thoracolumbar spinal cord 
only and be part of the DC 
group if pain/paresthesia 
overlap is at least 80%. 
Placement of leads 
adjacent to the 
lumbosacral dorsal 
nerve roots will be via a 
cranio-caudal approach 
in where the SCS lead 
will be inserted at the 
L1/L2 level and 
navigated caudally 
under fluoroscopic 
guidance. If the dorsal 
root lead(s) cannot be 
implanted due to 
patient-specific 
anatomy or other 
complications, the 
patient will be 
implanted with up to 2 
tightly spaced 
percutaneous leads over 
the thoracolumbar 
spinal cord only and be 
part of the DC/DR 
subgroup if 
pain/paresthesia 
overlap is at least 80%. 
 
Patients 
who 
don’t 
receive 
>80% 
paresthesia overlap with 
these DC leads and only 
experience 
>80% 
paresthesia overlap with 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Provide clarification 
on  patients with 
>80% paresthesia 
overlap with DR 
stimulation. 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 8 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
DR stimulation in the 
OR 
will 
only 
have 
lead(s) placed adjacent 
to 
the 
lumbosacral 
dorsal nerve roots and 
will proceed with the 
study as part of the 
DC/DR subgroup.   
 
B 
26-NOV-2019 
92120219 
Rev/Ver.C 
Section 9 (Study 
Design) and Section 
12 (Study Methods) 
Subjects for which 80% 
pain coverage is only 
achieved at the DC leads 
during the OR testing will 
receive a Boston Scientific 
Wavewriter ™ Spinal Cord 
Stimulator System and will 
be part of the DC cohort of 
the study. No 
randomization will be 
completed with these 
subjects. These subjects will 
receive DC perception-
based stimulation setting for 
approx. 4 ± 1.5 weeks. After 
this, the subject will have a 
washout period of up to 7 
days followed with a DC 
sub-perception based 
stimulation for approx. 6 ± 
2 weeks. Lastly, patients 
will enter a long term follow 
up of 12 weeks where 
Subjects for which 80% 
pain coverage is only 
achieved at the DC or 
DR leads, and not both, 
during the OR testing 
will receive a Boston 
Scientific Wavewriter 
™ Spinal Cord 
Stimulator System and 
will be part of the 
DC/DR cohort of the 
study. No 
randomization will be 
completed with these 
subjects. These subjects 
will receive DC/DR, 
respectively, 
perception-based 
stimulation setting for 
approx. 4 ± 1.5 weeks. 
After this, the subject 
will have a washout 
period of up to 7 days 
followed with a DC/DR, 
 
 
 
 
 
 
 
 
 
 
 
 
Provide clarification 
on  patients with 
>80% paresthesia 
overlap with DR 
stimulation 
 
 
 
 
 
 
 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 9 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
further optimizations may 
be done. 
 
 
 
 
 
 
 
The small DC subgroup 
allows for collection of data 
on DC outcomes. 
 
 
 
respectively, sub-
perception based 
stimulation for approx. 
6 ± 2 weeks. Lastly, 
patients will enter a 
long term follow up of 
12 weeks where further 
optimizations may be 
done. 
 
 
The small DC/DR 
subgroup allows for 
collection of data on 
DC/DR outcomes. 
 
 
 
 
 
 
 
 
 
 
 
Possibility that some 
subjects have DR lead 
coverage only; these 
subjects should have 
the possibility to enter 
the sub-study as well. 
B 
26-NOV-2019 
92120219 
Rev/Ver.C 
Section 11 Subject 
Accountability 
Patients with a failure to 
find the Sweet Spot 
(paresthesia overlap with 
pain) at both the DC & DR 
leads during OR testing will 
be withdrawn from the 
study. 
Patients with a failure 
to find the Sweet Spot 
(paresthesia overlap 
with pain) at neither the 
DC nor the DR leads 
during OR testing will 
be withdrawn from the 
study. 
Clarified that subjects 
who have no coverage 
at neither the DC nor 
the DR leads will be 
withdrawn from the 
study. 
B 
26-NOV-2019 
92120219 
Rev/Ver.C 
Section 
12 
(Study 
Methods) 
Randomization 
Randomization was 
deleted 
No randomization will 
occur in the sub-study 
B 
26-NOV-2019 
92120219 
Rev/Ver. C 
Section 
12 
(Study 
Methods) 
Programming Pre- and 
Post-visit Reports (program 
settings, impedance 
Programming Pre- and 
Post-visit Reports 
(program settings, 
impedance 
Copy of these reports, 
images and pain diary 
information to be send 
to Boston Scientific 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 10 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
measurements, program 
usage, battery voltage etc), 
Lead Fluoro images, Pain 
Diary information: retain at 
center 
measurements, 
program usage, battery 
voltage etc), Lead 
Fluoro images, Pain 
Diary information: 
retain at center and 
send copy to Boston 
Scientific 
B 
26-NOV-2019 
92120219 
Rev/Ver.C 
Figure 2.2 (FOCAL 
Sub-Study Design 
Flowchart) and 
Figure 7.2 (FOCAL 
Sub-Study Design 
Flowchart) 
DC Perception Based  
 
 
DC Sub-Perception 
DC/DR 
Perception 
Based 
 
 
DC/DR Sub-Perception 
Possibility that some 
subjects have DR lead 
coverage only; these 
subjects should have 
the possibility to enter 
the sub-study as well. 
C 
24-FEB-2021 
92120219 
Rev/Ver.F 
Protocol synopsis and 
Scale and Duration 
(Study Design) 
1 site in Belgium 
Up to 5 global sites 
Increase number of 
sites and increase 
flexibility to go to 
other countries.  
C 
24-FEB-2021 
92120219 
Rev/Ver.F 
Section 2 (Protocol 
Synopsis), Section 4 
(Introduction), 
Section 6 (Study 
Objectives and 
Endpoints), Section 8 
(Surgical 
Methodology), 
Section 9 (Study 
Design), Section 10 
(Subject Selection), 
Section 12 (Study 
Methods) 
Focal foot or knee pain 
Focal foot, knee or groin 
pain 
Extend subject 
population to include 
subjects with groin 
pain as well. 

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Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 11 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
C 
24-FEB-2021 
92120219 
Rev/Ver.F 
Risks associated with 
Participation in the 
Clinical Study 
Subjects who take part in 
this study are subject to 
similar risks shared by all 
subjects who receive the 
study 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 
doctor’s office. They may 
have an increased number of 
visits to the doctor’s office 
compared to standard of 
care. There may be some 
risks that are unknown. 
During the study the 
patients will be treated 
with different types of 
stimulation. Patients 
may find certain 
stimulation parameters 
to be less effective than 
others at reducing their 
pain and they might 
experience stimulation-
related side effects 
including, but not 
limited to, muscle 
spasm and discomfort, 
which the physician will 
address as per standard 
of care. This study is 
setup to collect data 
through questionnaires 
and diary. To complete 
these questionnaires, 
patients may spend 
additional time at the 
hospital compared to 
standard of care. 
Patients may have an 
increased number of 
visits to the doctor’s 
office compared to 
standard of care. 
Patients may find it 
difficult, uncomfortable 
or tiresome to complete 
Updated risk 
language.  

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 12 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
study visits, the pain 
diary and/or 
questionnaires.  
Patients who receive the 
device are subject to the 
same risks as patients 
outside of this study 
who receive the same or 
other similar 
commercial devices. 
However; there are 
additional risks related 
to the implantation of 
up to 2 electrodes at the 
lower level of the spine 
compared with the 
implantation of the 
electrodes at the 
standard level of the 
spine. In addition there 
is also a higher risk 
related to the number 
of electrodes implanted 
in the study (up to 4 
electrodes) compared 
with the number of 
electrodes implanted as 
standard of care (2 
electrodes only).  
The 
physician 
will 
explain to the patients 
the risks of the implant 
procedure, use of spinal 

Confidential 
Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 13 of 76 
 
Revision 
Version 
Protocol Date 
Template number and 
version 
Protocol Section 
Modified 
Existing Text as Written in 
Protocol, Version A 
Revised/New Text as 
Written in 
Protocol, Version C 
Justification for 
Modification 
cord stimulation and the 
known and significant 
interactions associated 
with 
the 
WaveWriterTM 
Technology and other 
medical procedures. All 
these are not considered 
part of the study and are 
done per standard of 
care. 

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Form/Template, 92120219, Rev/Ver.F 
FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 14 of 76 
 
 
2 Protocol Synopsis 
Focal Pain Outcomes using Configurations Applied for Lateral Stimulation 
FOCAL 
Study 
Objective(s) 
To evaluate Multiple Independent Current Control (MICC) perception 
and sub-perception based programming at Dorsal Column (DC) targets 
and Dorsal Root (DR) targets for focal foot,  knee, or groin pain relief. 
Device/System 
used in 
accordance with 
the Instructions 
For Use (IFU) 
WaveWriterTM Boston Scientific Spinal Cord Stimulation systems. 
Control Device 
applied as 
Standard of 
Care and sizes, 
if applicable 
None; each subject will serve as their own control. 
Study Design 
Multi-center, double blind randomized controlled cross-over (Study 
design flow chart, see Error! Reference source not found.). 
Planned 
Number of 
Subjects 
Up to 13 patients; 10 patients in the randomized group and up to 3 patients 
in the DC/DR subgroup. 
Planned 
Number of Sites 
/ Countries 
Up to 5 global sites.  
 
Primary 
Endpoint 
There is no primary endpoint. Collected data will be used to increase the 
understanding of the therapy, guide product development and help define the 
best practice for programming patients with focal foot, knee, or groin pain 
using Spinal Cord Stimulation devices.  
Safety 
parameters 
• 
Rate of device and/or procedure related non-serious adverse events  
• 
Rate of device and/or procedure related serious adverse events 
• 
Rate of unanticipated adverse device effects 
Exploratory 
Endpoints 
• 
Change in average foot,  knee, or groin pain and overall pain intensity 
from Baseline to end of each Period and End of Study (Pain Diary, 
NRS) 

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FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 15 of 76 
 
Focal Pain Outcomes using Configurations Applied for Lateral Stimulation 
FOCAL 
• 
Treatment Satisfaction at end of each Period and End of Study 
(PSWT) 
• 
Global impression of change at end of each Period and End of Study 
(PGIC) 
• 
Change in disability from Baseline to end of each Period and End of 
Study (ODI) 
• 
Change in Quality of life from Baseline to end of each Period and 
End of Study (EQ-5D-5L)  
• 
Change in sleep quality from Baseline to end of each Period and End 
of Study (PSQI) 
• 
Patient preferred program at end of Periods 2 and 4 (Preference 
Questionnaire)  
• 
Physician preferred program at end of Periods 2 and 4 (Preference 
Questionnaire)  
• 
Pain/paresthesia overlap for each tested perception based 
configuration (Pain/Paresthesia drawings) 
Method of 
Assigning 
Patients to 
Treatment 
Eligible subjects who consent to participation and have met all of the 
inclusion and none of the exclusion criteria.  
Only the patients with >80% paresthesia overlap with DC & DR 
stimulation in the OR will proceed with the randomization phase.   
Patients will be randomized 1:1 to DC and DR perception based stimulation 
setting for approx. 4 ± 1.5 weeks, followed by a crossover to the opposite 
programming setting for an additional approx. 4 ± 1.5 weeks.  
After this, the subject will have a washout period of up to 7 days and be 
randomized 1:1 to DC and DR sub-perception based stimulation for approx. 
6 ± 2 weeks followed by another washout period of up to 7 days. Patients 
will then crossover to the opposite lead implant for an additional 6 ± 2 
weeks of sub-perception therapy.  
Lastly, patients will enter a long term follow up of 12 weeks where further 
optimizations may be done.   
If the dorsal root lead(s) cannot be implanted due to patient-specific anatomy 
or other complications, the patient will be implanted with DC leads only.  
Only the patients with >80% paresthesia overlap with DC stimulation in 
the OR will proceed with the DC-specific programming periods.  
No randomization will be completed with these patients. These patients 
will receive DC perception based stimulation setting for approx. 4 ± 1.5 
weeks.  
After this, the subject will have a washout period of up to 7 days followed 
with a DC sub-perception based stimulation for approx. 6 ± 2 weeks. Lastly, 
patients will enter a long term follow up of 12 weeks where further 
optimizations may be done.   

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FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
Page 16 of 76 
 
Focal Pain Outcomes using Configurations Applied for Lateral Stimulation 
FOCAL 
Patients with only >80% paresthesia overlap with DR stimulation in the 
OR will proceed with the DR-specific programming periods.  
No randomization will be completed with these patients. These patients 
will receive DR perception based stimulation setting for approx. 4 ± 1.5 
weeks.  
After this, the subject will have a washout period of up to 7 days followed 
with a DR sub-perception based stimulation for approx. 6 ± 2 weeks. Lastly, 
patients will enter a long term follow up of 12 weeks where further 
optimizations may be done.   
Follow-up 
Schedule 
• 
Screening/Baseline Visit 
• 
Implant (contingent on >80% coverage of pain location in OR) 
Period 1 (4 ± 1.5 weeks) 
• 
Visit 1: Perception based search 
• 
Visit 2: Perception based evaluation 
• 
Visit 3: Perception based search for opposite lead 
Washout Period (up to 7 days) 
Period 2 (4 ± 1.5 weeks) 
• 
Call or Optional Visit: Perception based stimulation turn on  
• 
Visit 1: Perception based evaluation 
• 
Visit 2: Sub-perception based search (Randomized lead implant) 
Washout period (up to 7 days) 
Period 3 (6 ± 2 weeks)  
• 
Call or Optional Visit: Sub-perception based stimulation turn on  
• 
Visit 1: Sub-perception based evaluation 
• 
Visit 2: Sub-perception based search for opposite lead   
Washout period (up to 7 days) 
Period 4 visit (6 ± 2 weeks) 
• 
Call or Optional Visit: Sub-perception based stimulation turn on  
• 
Visit 1: Sub-perception based evaluation 
Long Term Follow up (12 ± 4 weeks) 
• 
Visit 1: Initial long-term follow-up visit 
• 
Call or Optional Visit: Long term follow-up evaluation   
• 
Visit 2: Final long-term follow-up visit = end of study 
Study Duration Enrollment is expected to be completed in approximately 12 months; 
therefore, the overall study may require up to 2 years to complete. 
Participant 
Duration 
Subjects who will be part of the main study cohort (= randomized group) 
and complete all study measurements will participate approximately 35 
weeks in the study. Subjects part of the substudy cohort (= DC/DR group) 

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FOCAL (A4068) Study Specific Protocol, 92289326, Rev/Ver.C 
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Focal Pain Outcomes using Configurations Applied for Lateral Stimulation 
FOCAL 
who complete all study measurements will participate approximately 24 
weeks in the study.  
Inclusion 
Criteria 
IC1. Average unilateral foot, knee, or groin pain (of neuropathic origin 
only) intensity of 6 or greater on a 0-10 numerical rating scale at Baseline 
Visit based on 7-day average NRS score 
IC2. Subject signed a valid, EC-approved informed consent form (ICF) 
IC3. Willing and able to comply with all protocol-required procedures 
and assessments/evaluations  
IC4. At least 80% pain/paresthesia overlap during on-table testing for 
each set of implanted leads  
Patients with at least 80% pain/paresthesia overlap at DC/DR leads 
only will be part of the DC/DR subgroup 
IC5. If taking prescription opioids for primary chronic pain complaint 
(low back and/or leg and/or foot and/or knee and/or groin pain), must have 
been on a stable prescription (same drug(s) and dose(s)) 30 days prior to 
Screening 
IC6. Consumed an average total daily morphine equivalent of ≤100 mg 
during the 30 days prior to Screening 
IC7. 18 years of age or older when written informed consent is obtained  
Exclusion 
Criteria 
EC1. Significant cognitive impairment at Screening that, in the opinion 
of the Investigator, would reasonably be expected to impair the study 
candidates to participate in the study 
EC2. Previous spinal cord stimulation trial or is already implanted with 
an active implantable device(s) (e.g. pacemaker, drug pump, implantable 
pulse generator). 
EC3. Participating (or intends to participate) in another drug or device 
clinical trial that may influence the data that will be collected for this 
study  
EC4. Currently on any anticoagulant medications that cannot be 
discontinued during perioperative period 
EC5. 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.  
EC6. Clinically significant lumbosacral stenosis which would interfere 
with lead placement 
EC7. Prior history of lumbar-sacral spine fusion   
Multiple 
Interventions  
NA 
Statistical Methods  

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Focal Pain Outcomes using Configurations Applied for Lateral Stimulation 
FOCAL 
Primary 
Statistical 
Hypothesis 
None 
Statistical Test 
Method 
Analysis of study data will include descriptive statistical methods in post-
hoc analysis. 
Sample Size 
Parameters 
No power estimates were used to drive sample size calculations.    
 

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Figure 2-1: FOCAL Main-Study Design Flowchart 

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Figure 2-2:  FOCAL Sub-Study Design Flowchart
/DR 
/DR 
Therapy (>80% coverage at DC/DR) 
confirmed in the OR 

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3 Table of Contents 
Table of Tables ................................................................................................................. 24 
4.1 
Chronic Intractable Pain ....................................................................................... 26 
4.2 
Conventional Spinal Cord Stimulation ................................................................ 26 
4.3 
Sub-perception Electrical Stimulation ................................................................. 27 
4.4 
Lateral nerve root stimulation for focal pain ...................................................... 27 
4.5 
Optimized lateral nerve root stimulation for focal foot or knee pain ............... 28 
9.1 
Scale and Duration ................................................................................................. 33 
9.2 
Treatment Assignment ........................................................................................... 33 
9.2.1 
Treatment and Control ............................................................................... 33 
9.3 
Justification for the Study Design ......................................................................... 33 
10.1 Study Population and Eligibility ........................................................................... 34 
10.2 Inclusion Criteria ................................................................................................... 34 
10.3 Exclusion Criteria .................................................................................................. 35 
11.1 Point of Enrollment ................................................................................................ 35 
11.2 Withdrawal ............................................................................................................. 35 
11.3 Lost to Follow-Up ................................................................................................... 36 
11.4 End-of-Study Definition......................................................................................... 37 
12.1 Data Collection ....................................................................................................... 37 
12.1.1 
Pain Diary .................................................................................................. 41 
12.1.2 
EQ-5D 5 Level (EQ-5D-5L) ...................................................................... 41 
12.1.3 
Numeric Rating Scale (NRS) ..................................................................... 41 
12.1.4 
Oswestry Disability Index (ODI) ............................................................... 41 
12.1.5 
Patient Satisfaction with Treatment (PSWT) ............................................ 41 
12.1.6 
Patient Global Impression of Change (PGI-C) .......................................... 42 
12.1.7 
Pittsburgh Sleep Quality Index (PSQI) ...................................................... 42 
12.1.8 
Procedure Information ............................................................................... 42 
12.1.9 
Programming Parameters ........................................................................... 42 
12.1.10 Electrical Mapping ..................................................................................... 42 
12.2 Study Candidate Screening ................................................................................... 42 
12.3 Informed Consent................................................................................................... 42 

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12.3.1 
Post-Consent Eligibility Validation ........................................................... 43 
12.4 Screening/Baseline Period (within 90 days prior to Implant procedure) ......... 43 
12.5 Lead + IPG Implant Visit ...................................................................................... 43 
12.6 Period 1 (4 weeks ± 10 days) .................................................................................. 44 
12.6.1 
Visit 1: Perception based search ................................................................ 44 
12.6.2 
Visit 2: Perception based evaluation .......................................................... 44 
12.6.3 
Visit 3: Evaluation and then Perception based search for crossover lead . 44 
12.7 Washout Period ...................................................................................................... 45 
12.8 Period 2 (4 weeks ± 10 days) .................................................................................. 45 
12.8.1 
Call or Optional Visit: Perception based stimulation turn on .................... 45 
12.8.2 
Visit 1: Perception based evaluation .......................................................... 45 
12.8.3 
Visit 2: Evaluation and then Sub-perception based search (Randomized lead 
implant) ...................................................................................................... 45 
12.9 Washout Period ...................................................................................................... 46 
12.10 Period 3 (6 weeks ± 14 days) .................................................................................. 46 
12.10.1 Call or Optional Visit: Sub-perception based stimulation turn on ............ 46 
12.10.2 Visit 1: Sub-perception based evaluation .................................................. 46 
12.10.3 Visit 2: Evaluation and then Sub-perception based search for crossover lead
 46 
12.11 Washout Period ...................................................................................................... 47 
12.12 Period 4 (6 weeks ± 14 days) .................................................................................. 47 
12.12.1 Call or Optional Visit: Sub-perception based stimulation turn on ............ 47 
12.12.2 Visit 1: Sub-perception based evaluation .................................................. 47 
12.13 Long Term Follow Up (12 weeks ± 28 days) ........................................................ 47 
12.13.1 Visit 1: Long Term Follow Up Visit ......................................................... 47 
12.13.2 Call or Optional Visit: Long term follow up evaluation ............................ 48 
12.13.3 Visit 2: Long Term Follow Up, Final End of Study Visit ......................... 48 
12.14 Unscheduled Visit ................................................................................................... 48 
12.15 Study Completion ................................................................................................... 48 
12.16 Source Documents .................................................................................................. 48 
13.1 Endpoints ................................................................................................................ 49 
13.1.1 
Primary Endpoint ....................................................................................... 49 

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13.1.1.1 Hypotheses ................................................................................ 49 
13.1.1.2 Sample Size ............................................................................... 49 
13.1.1.3 Statistical Methods .................................................................... 49 
13.1.2 
Exploratory Endpoints ............................................................................... 49 
13.2 General Statistical Methods .................................................................................. 50 
13.2.1 
Analysis Sets .............................................................................................. 50 
13.2.2 
Control of Systematic Error/Bias ............................................................... 50 
13.2.3 
Number of Subjects per Investigative Site ................................................ 50 
13.3 Data Analyses ......................................................................................................... 50 
13.3.1 
Other Endpoints/Measurements ................................................................. 50 
13.3.2 
Interim Analyses ........................................................................................ 50 
13.3.3 
Subgroup Analyses .................................................................................... 50 
13.3.4 
Justification of Pooling .............................................................................. 50 
13.3.5 
Multivariable Analyses .............................................................................. 50 
13.3.6 
Other Analyses ........................................................................................... 50 
14.1 Data Collection, Processing, and Review ............................................................. 51 
14.2 Data Retention ........................................................................................................ 51 
14.3 Core Laboratories .................................................................................................. 51 
16.1 Statement of Compliance ....................................................................................... 52 
16.2 Investigator Responsibilities ................................................................................. 52 
16.2.1 
Delegation of Responsibility ..................................................................... 54 
16.3 Institutional Review Board/ Ethics Committee ................................................... 54 
16.4 Sponsor Responsibilities ........................................................................................ 54 
16.4.1 
Role of Boston Scientific Representatives ................................................ 55 
16.5 Insurance ................................................................................................................. 56 
18.1 Instructionss for Use .............................................................................................. 56 
18.2 Risks associated with Participation in the Clinical Study .................................. 56 
18.3 Possible Interactions with Concomitant Medical Treatments, if applicable .... 57 
18.4 Risk Minimization Actions .................................................................................... 57 
18.5 Anticipated Benefits ............................................................................................... 57 
18.6 Risk to Benefit Rationale, if applicable ................................................................ 57 

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19.1 Reportable Events by investigational site to Boston Scientific .......................... 57 
19.2 Definitions and Classification................................................................................ 59 
19.3 Relationship to Device(s) and/or Study Procedure ............................................. 63 
19.4 Investigator Reporting Requirements .................................................................. 66 
19.5 Boston Scientific Device Deficiencies .................................................................... 68 
19.6 Reporting to Regulatory Authorities ECs / Investigators .................................. 68 
21.1 Safety Monitoring Process ..................................................................................... 70 
22.1 Premature Termination of the Study ................................................................... 70 
22.1.1 
Criteria for Premature Termination of the Study ....................................... 70 
22.2 Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval.................................................................................................................. 70 
22.3 Requirements for Documentation and Subject Follow-up ................................. 70 
22.4 Criteria for Suspending/Terminating a Study Site ............................................. 71 
23.1 Study Registration .................................................................................................. 71 
23.3 Publication Policy .................................................................................................... 72 
24.1 Subject Reimbursement .......................................................................................... 72 
24.2 Compensation for Subject’s Health Injury ........................................................... 72 
26.1 Abbreviations ........................................................................................................... 74 
26.2 Definitions ................................................................................................................. 76 
 
Table of Figures 
Figure 2-1: FOCAL Main-Study Design Flowchart ............................................................ 19 
Figure 2-2:  FOCAL Sub-Study Design Flowchart ............................................................. 20 
Figure 7-1: FOCAL Main-Study Design Flowchart ............................................................ 30 
Figure 7-2: FOCAL Sub-Study Design Flowchart .............................................................. 31 
Figure 8-1: Lead implant locations for dorsal column and dorsal root stimulation. The 
dorsal column lead implants will be medial over the spinal cord and the dorsal 
root lead implants will be lateral over the cauda equina ................................. 32 
Figure 12-1: CamNtech Ltd eDiary ....................................................................................... 41 
Table of Tables 
Table 10.2-1: Inclusion Criteria ................................................................................................ 34 
Table 10.3-1: Exclusion Criteria ............................................................................................... 35 

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Table 12.1-1: Data Collection Schedule Main-Study ............................................................... 38 
Table 12.1-2: Data Collection Schedule Sub-study .................................................................. 40 
Table 12.16-1: Source Documentation Requirements .............................................................. 49 
Table 19.2-1: Definitions and Classification ............................................................................ 61 
Table 19.3-1: Criteria for Assessing Relationship of Study Device, Stimulation or Procedure to 
Adverse Event ........................................................................................................ 64 
Table 19.4-1: Investigator Reporting Requirements ................................................................. 66 
Table 26.1-1: Abbreviations ..................................................................................................... 75 
Table 26.2-1: Definitions .......................................................................................................... 76 
 

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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 
can result in 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. Such pain can lead to a number of co-morbidities, including 
reduced health-related quality of life, reduced ability to engage in activities of daily living, 
increased disability, increased emotional depression, and weight gain due to the adoption of a 
sedentary lifestyle. Chronic low back and/or leg pain is typically categorized as either 
neuropathic, which involves pathological nerve activity and is commonly characterized by 
patients as ‘shooting’ or ‘burning’; nociceptive, which involves nerve signals indicating actual 
or impending tissue damage or inflammation (Grabois et al., 2005); or a varying mixture of 
neuropathic and nociceptive 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), 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 electrical current causes activation of  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 about location of the stimulation  induced paresthesia 
in response to various combinations of contact polarities (anodes and cathodes), pulse rate (or 
frequency), pulse amplitude (or current), and pulse width. 
In an international multi-center RCT, Kumar et al (2007) randomized 100 patients:  48 subjects 
to conventional medical management alone (CMM group) and 52 subjects to SCS plus CMM 
(SCS group).  At 6 months, patients randomized to SCS achieved significantly greater pain relief 
and improved functional capacity and health-related quality of life compared with patients 
randomized to CMM. Specifically, twenty four patients in the SCS group (48%) and four 

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patients in the CMM group (9%) achieved the primary outcome of 50% leg pain relief (p < 
0.001) at 6 months. This trend continued over the duration of 12 months as reported in Kumar 
2007 with the SCS group experiencing improved pain relief, quality of life and functional 
capacity, as well as greater treatment satisfaction (p ≤ 0.05). At 24 months (Kumar 2008), 37% 
of patients in SCS group continued to achieve at least 50% pain relief versus 2% of patients in 
the CMM group (p = 0.003). The results from the PROCESS study provide evidence that SCS 
is effective and cost effective in relieving chronic neuropathic pain associated with FBSS.   
4.3 
Sub-perception Electrical Stimulation 
Traditionally, SCS has relied on the understanding that to achieve pain relief, dorsal column 
stimulation-induced paresthesia has to be generated overlying the area of pain in order to 
successfully treat pain (North et al. 1991). However, recent studies indicate that effective pain 
relief may be obtained by employing stimulation without paresthesia.  
Van Buyten et al. (Van Buyten et al. 2012) reported the outcomes of a prospective, open-label, 
multicenter European clinical trial that utilized high frequency (up to 10 KHz) which did not 
produce paresthesia. Of 82 patients, 72 reported a significant improvement in VAS scores after 
trial and underwent permanent implantation. At six months, 74% of patients had a greater than 
50% pain relief in back pain. Al-Kaisy et al. (Al-Kaisy et al., 2014) reported the long term 
outcomes of this cohort at 24 months – Mean back pain was reduced from 8.4 ± 0.1 at baseline 
to 3.3 ± 0.3 at 24 months (p < 0.001), and mean leg pain was reduced from 5.4 ± 0.4 to 2.3 ± 
0.3 (p < 0.001). At 24 months, 60% of implanted patients had a greater than 50% pain relief in 
back pain.  
Thomson et al. (Thomson et al., 2018) reported outcomes of a multicenter, double-blind, 
crossover, randomized controlled trial (PROCO) that investigated the effects of rate on analgesia 
in kilohertz frequency (1–10 kHz) spinal cord stimulation (SCS). The sweet spot identified at 
10 kHz in all patients was tested at 1, 4, 7, and 10 kHz SCS in randomized order (four weeks at 
each frequency). With appropriate titration of pulse width and amplitude, all frequencies 
resulted in equivalent pain relief (p < 0.002). The charge was not constant across all frequencies 
and 1 kHz stimulation required significantly less charge than higher frequencies. 
 
DeRidder et al. (DeRidder et al 2010) reported the outcomes of a new stimulation paradigm 
(burst) used in 12 patients without paresthesia induction. During the trial period, an 
improvement of 5.25 points on VAS for axial pain for burst stimulation (p < 0.001) was reported 
versus a 1.83 points improvement for tonic stimulation. After more than 1 yr. of follow up, 
significant reduction in VAS scores for axial pain of 3.7 points and for limb pain of 5.15 points 
was noted with burst stimulation.  
4.4 
Lateral nerve root stimulation for focal pain 
Lateral stimulation, leads placed laterally in the epidural space to target roots has been 
previously reported (Palmeri et al., 2012 and Sharan et al., 2008). MacDougall et al. has recently 
published outcomes in an open label, single site, prospective study (MacDougall et al., 2017) 
using lateral stimulation to target nerve roots. In the patients that recevied laterally implanted 
leads targeting DNR (dorsal nerve root), there was a VAS score decrease from 7.5 (SD 1.4) to 

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4.4 (SD 2.6). Forty seven percent of patients with permanent DNR stimulation implants 
achieved at least 50% pain relief. Dr. Pyles has published outcomes (Pyles et al., 2017) using 
lateral stimulation to target foot pain. Leads were placed antegrade through the sacral hiatus 
within a range of L5 - S1. The average decrease in pain was 6.3 across 9 patients. Both standard 
stimulation parameters and higher rates were tested. At the final follow up, 55.6% of patients 
were using standard based programs and 44.4% of patients were using higher rates. 
4.5 
Optimized lateral nerve root stimulation for focal foot,  knee, or groin pain 
Outcomes reported by Drs. Parrent, MacDougall, and Pyles, have shown lateral stimulation to 
be effective for targeting focal pain with a single lead implanted on each side.  Paddle leads with 
multiple columns have also been used to target roots (data not published). 
The purpose of this study is to explore spatial sensitivity and frequency sensitivity in sub-
perception in lateral nerve root stimulation to obtain initial impressions of effects. 
5 Device Description (used in accordance with the IFU) 
This study includes Boston Scientific Spectra WaveWriterTM neurostimulation system and 
percutaneous linear leads.  
6 Study Objectives and Endpoints 
The objective of this study is to evaluate MICC perception and sub-perception based 
programming at DC and DR targets for focal pain relief. We will also collect data to build 
experience on how to use MICC to create focal paresthesia and analgesia in focal pain patients 
as well as how to use MICC to create sub-perception based analgesia in focal pain patients. 
There is no Primary Endpoint for this exploratory study. 
The following Safety parameters will be collected in the study: 
- 
Rate of device and/or procedure related non-serious adverse events  
- 
Rate of device and/or procedure related serious adverse events 
- 
Rate of unanticipated adverse device effects 
The following Exploratory Endpoints will be collected in this study: 
• 
Change in average foot, knee, or groin pain and overall pain intensity from Baseline to end 
of each Period and End of Study (Pain Diary, NRS) 
• 
Treatment Satisfaction at end of each Period and End of Study (PSWT) 
• 
Global impression of change at end of each Period and End of Study (PGIC) 
• 
Change in disability from Baseline to end of each Period and End of Study (ODI) 
• 
Change in Quality of life from Baseline to end of each Period and End of Study (EQ-5D-
5L)  
• 
Change in sleep quality from Baseline to end of each Period and End of Study (PSQI) 
• 
Patient preferred program at end of Periods 2 and 4 (Preference Questionnaire)  
• 
Physician preferred program at end of Periods 2 and 4 (Preference Questionnaire) 
• 
Pain/paresthesia overlap for each tested perception based configurations (Pain/Paresthesia 
drawings) 
 

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7 Study Design 
Prospective, post-market, exploratory, multi-center, randomized, cross-over. The study design is shown in  
Figure 7-1 and                       Figure 7-2. 
 

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Figure 7-1: FOCAL Main-Study Design Flowchart 

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                      Figure 7-2: FOCAL Sub-Study Design Flowchart
/DR 
/DR 
Therapy (>80% coverage at DC/DR) 
confirmed in the OR 

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8 Surgical Methodology 
Subjects with a history of unilateral neuropathic foot, knee, or groin pain will be enrolled.  
Subjects will be implanted with up to 2 tightly spaced percutaneous leads placed over the 
thoracolumbar spinal cord and up to 2 additional tightly spaced percutaneous leads placed 
adjacent to the T11-S1 dorsal nerve roots ipsilateral to the subject’s foot/knee/groin pain. The 
spatial arrangement of the leads is shown in Error! Reference source not found.. 
Placement of leads adjacent to the T11-S1 dorsal nerve roots will be via a cranio-caudal 
approach in where the SCS lead will be inserted at the T11/T12, T12/L1, or L1/L2 level and 
navigated caudally under fluoroscopic guidance. If the dorsal root lead(s) cannot be implanted 
due to patient-specific anatomy or other complications, the patient will be implanted with up 
to 2 tightly spaced percutaneous leads over the thoracolumbar spinal cord only and be part of 
the DC/DR subgroup if pain/paresthesia overlap is at least 80%. 
Placement of the leads over the thoracolumbar spinal cord will be via an anterograde approach.  
 
Patients who don’t receive >80% paresthesia overlap with these DC leads and only experience 
>80% paresthesia overlap with DR stimulation in the OR will only have lead(s) placed adjacent 
to the T11-S1 dorsal nerve roots and will proceed with the study as part of the DC/DR 
subgroup.   
 
Figure 8-1: Lead implant locations for dorsal column and dorsal root stimulation. The 
dorsal column lead implants will be medial over the spinal cord and the dorsal root lead 
implants will be lateral over the cauda equina 

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9 Study Design 
9.1 
Scale and Duration 
The study will be conducted at up to 5 global sites. Approximately thirteen (13) subjects will be 
enrolled in the study. 10 Subjects who will be part of the main study cohort (= randomized group) 
and complete all study measurements will participate approximately 35 weeks in the study. 
Subjects part of the substudy cohort (= DC/DR group) who complete all study measurements will 
participate approximately 25 weeks in the study. The overall study may require up to 2 years to 
complete. 
9.2 
Treatment Assignment 
Eligible patients who consent to participation and have met all of the inclusion and none of the 
exclusion criteria will undergo implant of the system.  
Subjects for which an 80% pain coverage is achieved at both the DR and DC leads during the OR 
testing will receive a Boston Scientific WaveWriter™ Spinal Cord Stimulator System and will be 
part of the main cohort (Randomized cohort) of the study. These patients will be randomized 1:1 
to DC or DR perception based stimulation setting for approx. 4 ± 1.5 weeks, followed by a 
crossover to the opposite programming setting for additional approx. 4 ± 1.5 weeks after washout 
period of up to 7 days. After this, the subject will have a washout period of up to 7 days and be 
randomized 1:1 to DC or DR sub-perception based stimulation for approx. 6 ± 2 weeks, followed 
by a washout period of up to 7 days and then crossover to the opposite programming setting for an 
additional approx. 6 ± 2 week.  The subject then enters into a 3-month follow-up period where 
further therapy optimizations may be done.  
Subjects for which 80% pain coverage is only achieved at the DC or DR leads, and not both, during 
the OR testing will receive a Boston Scientific Wavewriter ™ Spinal Cord Stimulator System and 
will be part of the DC/DR cohort of the study. No randomization will be completed with these 
subjects. These subjects will receive DC/DR, respectively, perception-based stimulation setting 
for approx. 4 ± 1.5 weeks. After this, the subject will have a washout period of up to 7 days followed 
with a DC/DR, respectively, sub-perception based stimulation for approx. 6 ± 2 weeks. Lastly, 
patients will enter a long term follow up of 12 weeks where further optimizations may be done.   
Subjects for which 80% pain coverage is achieved at neither the DR or DC leads during the 
OR testing will not receive a Boston Scientific Spinal Cord Stimulator System and will be 
excluded from the study. 
9.2.1 Treatment and Control 
This study compares two stimulation implant locations, DC and DR, with both perception 
based and sub-perception types of stimulation. The cross-over study design allows for 
comparing these treatments using one of the stimulation types as an active control.  
9.3 
Justification for the Study Design 
The study design is prospective, postmarked, exploratory, single-center, randomized, double-
blinded (subject, evaluator blinded; programmer un-blinded) study to obtain initial impression 
on the sensitivity to location and frequency of stimulation at the DC and DR lead locations for 

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chronic neuropathic foot, knee, or groin pain treatment. It is exploratory because little is known 
about the best electric field location and frequency to optimize focal foot,  knee, or groin pain 
relief at DC or DR targets. Randomization will allow for controlling for order effect as previous 
research in SCS has shown that the order effect can dominate the treatment effect (Perruchoud 
et al., 2013). The small DC/DR subgroup allows for collection of data on DC/DR outcomes. 
10 Subject Selection  
10.1 Study Population and Eligibility  
The Study will include up to 13 patients of which 10 subjects will be randomized and 
approximately 3 subjects will be part of the DC/DR subgroup.  Subjects will generally be recruited 
from physician’s practice and will be eligible to receive DC and DR Spinal Cord Stimulation 
therapy to treat their chronic neuropathic foot, knee, or groin pain condition in using the CE-
marked Spectra WaveWriter™ Spinal Cord Stimulator System per local IFU.  
10.2 Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 10.2-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 10.3) is 
met.  
Table 10.2-1: Inclusion Criteria 
Inclusion 
Criteria 
IC1. Average unilateral foot, knee, or groin pain (of neuropathic origin only) 
intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit 
based on 7-day average NRS score 
IC2. Subject signed a valid, EC-approved informed consent form (ICF) 
IC3. Willing and able to comply with all protocol-required procedures and 
assessments/evaluations  
IC4. At least 80% pain/paresthesia overlap during on-table testing for each 
set of implanted leads  
Patients with at least 80% pain/paresthesia overlap at DC/DR leads only 
will be part of the DC/DR subgroup 
IC5. If taking prescription opioids for primary chronic pain complaint (low 
back and/or leg and/or foot and/or knee and/or groin pain), must have been 
on a stable prescription (same drug(s) and dose(s)) 30 days prior to Screening 
IC6. Consumed an average total daily morphine equivalent of ≤100 mg 
during the 30 days prior to Screening 
IC7. 18 years of age or older when written informed consent is obtained 
 
 

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10.3 Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 10.3-1) cannot be included in this 
study or will be excluded from this clinical study. 
Table 10.3-1: Exclusion Criteria 
Exclusion 
Criteria 
 EC1. Significant cognitive impairment at Screening that, in the opinion of 
the Investigator, would reasonably be expected to impair the study candidates 
to participate in the study 
EC2. Previous spinal cord stimulation trial or is already implanted with an 
active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse 
generator). 
EC3. Participating (or intends to participate) in another drug or device clinical 
trial that may influence the data that will be collected for this study  
EC4. Currently on any anticoagulant medications that cannot be discontinued 
during perioperative period 
EC5. 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. 
EC6. Clinically significant lumbosacral stenosis which would interfere with 
lead placement 
EC7. Prior history of lumbar-sacral spine fusion   
 
11 Subject Accountability 
11.1 Point of Enrollment 
A subject will be considered enrolled in this study after he/she signs and dates the informed 
consent form (ICF). No study-related procedures or assessments can take place until the 
informed consent form is signed. Patients with a failure to find the Sweet Spot (paresthesia 
overlap with pain) at neither the DC nor the DR leads during OR testing will be withdrawn 
from the study. All applicable case report forms (CRFs) up to the point of subject withdrawal 
and an “End of Study” form must be completed. Additional data may no longer be collected 
after the point at which a subject has been withdrawn from the study. Data collected up to the 
point of subject withdrawal may be used and analyzed. These patients will not be count towards 
the enrollment ceiling. 
11.2 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 investigational device safety or performance, the investigator shall ask for the 
subject’s permission to follow his/her status/condition outside of the clinical study.   

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Reasons for withdrawal could include but are not limited to: 
 Physician discretion  
• Subject’s choice to withdraw consent;  
• Subject’s failure to meet inclusion or not meet exclusion criteria after enrollment but 
prior to first study related programming 
• Failure to find the Sweet Spot (paresthesia overlap with pain) at neither the DC nor DR 
leads during OR testing 
• Subject is lost to follow-up or  
• Subject’s death   
While study withdrawal is discouraged, subjects may withdraw from the study at any time, 
with or without reason, and without prejudice to further treatment. 
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. 
Withdrawn subjects will not be included in the site’s overall total for subjects. 
11.3  Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she fails to return for 1 of the 
programming visits and is unable to be contacted by the study site staff.  
The following actions must be taken if a participant fails to return to the clinic for a required 
programming visit: 
• The site will attempt to contact the participant and reschedule the missed visit and 
counsel the participant on the importance of maintaining the assigned visit schedule 
and ascertain if the participant wishes to and/or should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the participant (where possible, 3 telephone calls 
and, if necessary, a certified letter to the participant’s last known mailing address or 
local equivalent methods). These contact attempts should be documented in the 
participant’s medical record or study file.  
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
 

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11.4 End-of-Study Definition  
A participant is considered to have completed the study if he or she has completed all phases 
of the study including the last visit shown in the Data Collection Schedule. 
The end of the study is defined as completion of the last visit or procedure shown in the Data 
Collection Schedule in the trial. 
12 Study Methods 
12.1 Data Collection 
The data collection schedule is shown in Table 12.1-1 and  
Table 12.1-2, as well as described below. 

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Table 12.1-1: Data Collection Schedule Main-Study 
Procedure 
/Assessment 
Screening/ 
Baseline 
Lead + IPG 
Implant  
Procedure  
Postprocedure/ 
Prehospital 
Discharge 
Follow-up Visits 
P1 
V1 
P1 
V2 
P1 
V3 
P2 
C/V 
P2 
V1 
P2 
V2 
P3 
C/V 
P3 
V1 
P3 
V2 
P4 
C/V 
P4 
V1 
LTF 
V1 
LTF 
C/V 
LTF 
V2 
UnS 
Visit 
Informed consent  
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
Eligibility review 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
Demographics & 
Medical History 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
SCS Procedure 
- 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
Numeric Rating 
Scale (NRS)  
X 
- 
- 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Therapy 
Satisfaction 
(PSWT)  
- 
- 
- 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Patient Global 
Impression of 
Change (PGIC) 
- 
- 
- 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Disability (ODI) 
X 
- 
- 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Quality of life  
(EQ-5D-5L) 
X 
- 
- 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Sleep quality 
(PSQI) 
X 
- 
- 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Physician & Patient 
Preference 
- 
- 
- 
- 
- 
- 
- 
- 
X 
- 
- 
- 
- 
- 
X 
- 
- 
- 
 

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Procedure 
/Assessment 
Screening/ 
Baseline 
Lead + IPG 
Implant  
Procedure  
Postprocedure/ 
Prehospital 
Discharge 
Follow-up Visits 
P1 
V1 
P1 
V2 
P1 
V3 
P2 
C/V 
P2 
V1 
P2 
V2 
P3 
C/V 
P3 
V1 
P3 
V2 
P4 
C/V 
P4 
V1 
LTF 
V1 
LTF 
C/V 
LTF 
V2 
UnS 
Visit 
Electrical Mapping 
- 
- 
- 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
X# 
Pain Drawing 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
X 
- 
Device 
Programming 
Report 
- 
- 
- 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Lead Fluoro Image 
- 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
X** 
Randomization 
- 
- 
- 
X 
- 
- 
- 
- 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
Medication 
information 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse 
Events/Device 
Deficiencies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Protocol Deviations 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Note: The patient will be filling out a Pain Diary daily throughout the study 
**: In the event that Investigator suspects lead migration, per standard of care 
#: for all stim combos tested 
 

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Table 12.1-2: Data Collection Schedule Sub-study 
Procedure /Assessment 
Screening/ 
Baseline 
Lead + IPG 
Implant  
Procedure  
Postprocedure/ 
Prehospital 
Discharge 
Follow-up Visits 
P 1 
V1 
P 1 
V2 
P 1 
V3 
P 3 
C/V 
P3 
V1 
LTF 
V1 
LTF 
C/V 
LTF 
V2 
UnS 
Visit 
Informed consent  
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
Eligibility review 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
Demographics & Medical History 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
SCS Procedure 
- 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
Numeric Rating Scale (NRS)  
X 
- 
- 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Therapy Satisfaction (PSWT)  
- 
- 
- 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Patient Global Impression of Change 
(PGIC) 
- 
- 
- 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Disability (ODI) 
X 
- 
- 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Quality of life (EQ-5D-5L) 
X 
- 
- 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Sleep quality (PSQI) 
X 
- 
- 
- 
- 
X 
- 
- 
X 
- 
X 
- 
Electrical Mapping 
- 
- 
- 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pain Drawing 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
X 
- 
Device Programming Report 
- 
- 
- 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Lead Fluoro Image 
- 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
X** 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medication information 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events/Device Deficiencies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Protocol deviations 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
**: In the event that Investigator suspects lead migration, per standard of care 

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12.1.1 Pain Diary  
The patient will be asked to collect information about their pain on a daily basis with an 
eDiary. A paper version of the diary will be included as a backup if the eDiary 
malfunctions or the patient experiences difficulties with the eDiary recordings. 
The eDiary is compact wrist-worn electronic diary manufactured by CamNtech Ltd 
programmed specifically for this study.  Data entry is interactive and based on a series of 
questions and is dated and time stamped. Specific training materials for the use of the 
eDiary will be provided to each study subject. 
 
Figure 12-1: CamNtech Ltd eDiary 
Subjects who meet the applicable inclusion and none of the exclusion criteria will be given 
an eDiary to capture daily pain intensity assessments two times a day (morning and 
evening). Activity data will be collected automatically via an accelerometer. 
An alarm will sound at these times to ask subjects to report information.  If the subject 
fails to enter the required information, the data for that event will be classified as missing. 
12.1.2 EQ-5D 5 Level (EQ-5D-5L) 
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale.  The 
descriptive system measures quality of life along five dimensions, including mobility, 
self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for 
each dimension from which subjects are asked to select one. 
12.1.3 Numeric Rating Scale (NRS) 
NRS will be used to measure the pain intensity, enabling the subject to express the severity 
of pain by giving it a numerical value from 0 to 10.   
12.1.4 Oswestry Disability Index (ODI) 
Oswestry Disability Index is a commonly used scale for back pain subjects with a 
neuropathic pain component.  The test is considered the ‘gold standard’ of low back 
functional outcome tools. 
12.1.5 Patient Satisfaction with Treatment (PSWT) 
The Patient Satisfaction With Treatment survey will be used at the end of each Period and at 
end of study.  

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12.1.6 Patient Global Impression of Change (PGI-C) 
PGI-C is a standard seven-point scale used to assess the SCS outcome. 
12.1.7 Pittsburgh Sleep Quality Index (PSQI) 
PSQI is a self-rated questionnaire assessing sleep quality and disturbances. This 
questionnaire includes 19 individual items grouped into 7 component scores: subjective 
sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, 
use of sleeping medication, and daytime dysfunction. The sum of these 7 scores yields a 
single global score. 
12.1.8 Procedure Information 
General information will be collected regarding the SCS procedures performed during the 
study, including leads used, locations at test/implant and AP fluoroscope image.    
12.1.9 Programming Parameters 
Standard information regarding the programming parameters used to program the 
subject’s ETS/IPG including measurements taken using the device (program settings, 
impedance measurements, program usage, battery voltage etc.) will be collected from the 
Clinician Programmer (CP). The data will not contain patient identifiable information.  
12.1.10Electrical Mapping 
A series of measurements of stimulation sensory thresholds and stimulation induced 
paresthesia drawings which are intended to assist in determining the clinically optimal 
stimulation parameters for perception based and sub-perception SCS. 
12.2 Study Candidate Screening 
The study clinicians will use the medical record to assess the likelihood that the subject will 
meet all the inclusion criteria (Table 10.2-1: Inclusion Criteria) and none of the exclusion 
criteria (Table Table 10.3-1: Exclusion Criteria). Those subjects who are deemed as having 
a high likelihood of meeting these requirements will be contacted regarding their interest in 
study participation 
12.3 Informed Consent 
Written Informed Consent must be obtained for all patients who are potential study candidates. 
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 to the subject in 
language that is easily understood by the subject. The subjects must also be given the 
opportunity to ask questions and have those questions answered to their satisfaction. The 
Informed Consent form is study specific and must be approved by the study Independent Ethics 
Committee (IEC). Study personnel should explain that even if a subject agrees to participate 
in the study and signs an ICF, certain diagnostic or screening procedures might demonstrate 
that the subject is not eligible to continue (see Table 10.2-1: Inclusion Criteria and Table 
10.3-1: Exclusion Criteria). 

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12.3.1 Post-Consent Eligibility Validation 
Certain inclusion criteria will be confirmed only after the patient has provided the written 
informed consent and if they are not met, the subject will be withdrawn from study 
participation. The withdrawn patients will continue their treatment per center’s standard of 
care.   
12.4 Screening/Baseline Period (within 90 days prior to Implant procedure)  
Visit type: period at home + office  
This occurs after the subject has provided written informed consent. The screening period 
should occur no more than 90 days prior to SCS Implant procedure. At the end of the screening 
period, it will be confirmed whether inclusion criteria are met.  
Goal: Document pain scores and various quality of life measures to understand baseline pain 
condition and confirm eligibility of the subject. Provide an eDiary to collect a baseline eDiary 
pain score over 7 days. 
12.5 Lead + IPG Implant Visit   
Subjects with unilateral neuropathic foot,  knee, or groin pain will be implanted with up to 2 
tightly spaced percutaneous leads placed over the thoracolumbar spinal cord and up to 2 
additional tightly spaced percutaneous leads placed adjacent to the T11-S1 dorsal nerve roots 
ipsilateral to the subject’s foot, knee, or groin pain. The spatial arrangement of the leads is 
shown in  
Figure 8-1. 
Placement of leads adjacent to the T11-S1 dorsal nerve roots will occur first and will be 
performed via a cranio-caudal approach in where the SCS lead will be inserted at the T11/T12, 
T12/L1, or L1/L2 level and navigated caudally under fluoroscopic guidance. If the dorsal root 
lead(s) cannot be implanted due to patient-specific anatomy or other complications, the patient 
will be implanted with up to 2 tightly spaced percutaneous leads over the thoracolumbar spinal 
cord only. Placement of the leads over the thoracolumbar spinal cord will be via an anterograde 
approach. 
Subjects for which an 80% pain coverage is achieved at both the DR and DC leads during the OR 
testing will receive a Boston Scientific Wavewriter ™ Spinal Cord Stimulator System and will be 
part of the main cohort (Randomized cohort) of the study.  
Subjects for which 80% pain coverage is only achieved at the DC or DR leads during the OR 
testing will receive a Boston Scientific Spinal Cord Stimulator System and will be part of the sub 
study cohort (DC/DR cohort) of the study. No randomization will be done with these subjects.  
Subjects for which 80% pain coverage is achieved at neither the DR nor DC leads during the OR 
testing will not receive a Boston Scientific Spinal Cord Stimulator System and will be excluded 
from the study. 
The section below provides a detailed study schedule for the patients included in the main 
cohort of the study (randomized cohort). The study schedule for patients included in the sub 
study cohort (DC/DR cohort) is identical except for the randomization which will not be 

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completed with these patients. These patients will receive DC/DR, respectively, perception 
based stimulation setting for approx. 4 ± 1.5 weeks. After this, the subject will have a wash out 
period followed with a DC/DR, respectively, sub-perception based stimulation for approx. 6 ± 2 
weeks.  Lastly, patients will enter a long term follow up of 12 weeks where further 
optimizations may be done.  
12.6 Period 1 (4 weeks ± 10 days)    
Patients will be randomized 1:1 to either DC or DR lead implants using perception based 
therapy for 4 weeks ± 10 days. 
Goal: The goal of this period is to ensure that the subject’s system is tested using various 
perception based programs, amplitude, frequency, and pulse width values to optimize pain 
relief. Selected stimulation programs will be tested and documented. To determine the 
stimulation effect, pain score, satisfaction with treatment, global impression of change and 
physical activity tolerance times may be used. Multiple programming visits may be performed 
during this period (unscheduled visits). Regular contact with subject is recommended. 
12.6.1 Visit 1: Perception based search  
Visit type: office 
Goal: The goal of this visit is to ensure that the subject’s system is tested using various 
perception based programs, amplitude, frequency, and pulse width values to optimize 
pain relief. Selected stimulation programs will be tested and documented.  
12.6.2 Visit 2: Perception based evaluation  
Visit type: office  
Goal: Selected stimulation programs will be tested and documented. The goal of this 
visit is to select the perception based program preferred by the patient from the tested 
programs. The patient will be provided with the best perception based program to use 
at the end of the session.  
12.6.3 Visit 3: Evaluation and then Perception based search for crossover lead  
Visit type: office 
Goal: The first goal of this visit is to evaluate the previously selected perception based 
program. To determine the stimulation effect, pain score, satisfaction with treatment, 
global impression of change and physical activity tolerance times may be used. The 
second goal of this visit is to crossover to the opposite lead implant and ensure that the 
subject’s system is tested using various perception based programs, amplitude and 
pulse width values to optimize pain relief. Selected stimulation programs will be tested 
and documented. The patient will leave the end of the session with new programs for 
the crossover lead and with stimulation turned OFF. 

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12.7 Washout Period 
The subject’s device will remain inactivated (device OFF) until 80% average NRS baseline 
reached or for a maximum 7 days with less than 80% average NRS from baseline.  Subjects 
will continue to complete their eDiary daily (twice/day) during this period. 
 
12.8 Period 2 (4 weeks ± 10 days) 
This period is a crossover to the opposite lead implant selected in Randomized Period 1 during 
Visits 1 and 2 (same location tested at the end of the session Randomized Period 1, Visit 3) for 
an additional 4 weeks ± 10 days of perception based therapy. 
Goal: The goal of this period is to ensure that the subject’s system is tested using various 
perception based programs, amplitude, frequency, and pulse width values to optimize pain 
relief. Selected stimulation programs will be tested and documented. To determine the 
stimulation effect, pain score, satisfaction with treatment, global impression of change and 
physical activity tolerance times may be used. Multiple programming visits may be performed 
during this period (unscheduled visits). Regular contact with subject is recommended. 
12.8.1  Call or Optional Visit: Perception based stimulation turn on   
Visit type: office or home 
Goal: The patient will contact the site after the washout period. The site will contact 
the patient if they do not hear from the patient. The goal of this call or visit is to turn 
ON the perception based programs from Randomized Period 1, Visit 3. 
12.8.2 Visit 1: Perception based evaluation  
Visit type: office 
Goal: The first goal of this visit is to evaluate the perception based program with the 
most pain relief. The second goal of this visit is to ensure that the subject’s system is 
tested using various perception based programs, amplitude, frequency, and pulse width 
values to optimize pain relief. Selected stimulation programs will be tested and 
documented. 
12.8.3 Visit 2: Evaluation and then Sub-perception based search (Randomized lead 
implant)  
Visit type: office 
Goal: The first goal of this visit is to evaluate the previously selected perception based 
program. To determine the stimulation effect, pain score, satisfaction with treatment, 
global impression of change and physical activity tolerance times may be used. The 
second goal of this visit is to randomize lead implant position and create sub-perception 
based programs for the patient to take home. Selected stimulation programs will be 
tested and documented. The patient will leave the end of the session with new programs 
with stimulation turned OFF. 

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12.9 Washout Period 
The subject’s device will remain inactivated (device OFF) until 80% average NRS baseline 
reached or for a maximum 7 days with less than 80% average NRS from baseline.  Subjects 
will continue to complete their eDiary daily during this period. 
 
12.10 Period 3 (6 weeks ± 14 days)   
After a washout period of 80% baseline or up to 7 days, patients will be tested at the 
randomized DC or DR lead implants (determined at Period 2, Visit 2) using sub-perception 
based therapy for 6 weeks ± 14 days 
Goal: The goal of this period is to ensure that the subject’s system is tested using various 
sub-perception based programs, amplitude frequency, and pulse width values to optimize 
pain relief. Selected stimulation programs will be tested and documented. To determine the 
stimulation effect, pain score, satisfaction with treatment, global impression of change and 
physical activity tolerance times may be used. Multiple programming visits may be 
performed during this period (unscheduled visits). Regular contact with subject is 
recommended. 
12.10.1Call or Optional Visit: Sub-perception based stimulation turn on   
Visit type: office or home 
Goal: The patient will contact the site after the washout period. The site will contact 
the patient if they do not hear from the patient. The goal of this visit is to turn ON the 
sub-perception based programs from Period 2, Visit 2. 
12.10.2Visit 1: Sub-perception based evaluation  
Visit type: office 
Goal: The goal of this visit is to ensure that the subject’s system is tested using various 
sub-perception based programs, amplitude, frequency, and pulse width values to 
optimize pain relief. Selected stimulation programs will be tested and documented. 
12.10.3Visit 2: Evaluation and then Sub-perception based search for crossover lead  
Visit type: office 
Goal: First, the goal of this visit is to evaluate test programs using various sub-
perception based programs, amplitude, frequency, and pulse width values to optimize 
pain relief. Selected stimulation programs will be tested and documented. To determine 
the stimulation effect, pain score, satisfaction with treatment, global impression of 
change and physical activity tolerance times may be used. Secondly, the patient will 
crossover to the opposite lead location and will be given sub-perception programs to 
take home. The patient will leave with stimualtion turned OFF. 

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12.11 Washout Period 
The subject’s device will remain inactivated (device OFF) until 80% average NRS baseline 
reached or for a maximum 7 days with less than 80% average NRS from baseline.  Subjects 
will continue to complete their eDiary daily during this period. 
12.12 Period 4 (6 weeks ± 14 days)   
After a washout period of 80% baseline or up to 7 days, sub-perception programs will be tested 
in the opposite lead implant location (determined in Randomized Period 3, Visit 2). 
 
Goal: The goal of this period is to ensure that the subject’s system is tested using various sub-
perception based programs, amplitude, frequency, and pulse width values to optimize pain 
relief. Selected stimulation programs will be tested and documented. To determine the 
stimulation effect, pain score, satisfaction with treatment, global impression of change and 
physical activity tolerance times may be used. Multiple programming visits may be performed 
during this period (unscheduled visits). Regular contact with subject is recommended 
12.12.1Call or Optional Visit: Sub-perception based stimulation turn on   
Visit type: office or home 
Goal: The patient will contact the site after the washout period or earlier if NRS >80% 
of baseline value. The site will contact the patient if they do not hear from the patient. 
The goal of this visit is to turn ON the sub-perception based programs from 
Randomized Period 3, Visit 2.  
12.12.2Visit 1: Sub-perception based evaluation  
Visit type: office 
Goal: The goal of this visit is to ensure that the subject’s system is tested using various 
sub-perception based programs, amplitude, frequency, and pulse width values to 
optimize pain relief. Selected stimulation programs will be tested and documented.  
12.13 Long Term Follow Up (12 weeks ± 28 days)  
Goal: The goal of this period is to evaluate multiple test programs to minimize energy 
usage and maintain optimal therapy. Multiple programming visits may be performed 
during this period (unscheduled visits). Regular contact with subject is recommended. 
12.13.1Visit 1: Long Term Follow Up Visit  
Visit type: office 
Goal: The first goal of this visit is to evaluate the previously selected sub-perception 
based program. To determine the stimulation effect, pain score, satisfaction with 
treatment, global impression of change and physical activity tolerance times may be 
used. Secondly, the goal of this visit is to provide multiple test programs to minimize 
energy usage and maintain optimal therapy. Selected stimulation programs will be 
tested and documented. Multiple programming visits may be performed during this 
period (unscheduled visits). 

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12.13.2Call or Optional Visit: Long term follow up evaluation   
Visit type: office or home 
Goal: Subject will be encouraged to keep their preferred program. Further therapy 
optimizations are allowed in this period (physician discretion). Multiple programming 
visits may be done during this period (unscheduled). Determine patient preference 
amongst all programs that were provided to the patient. 
12.13.3Visit 2: Long Term Follow Up, Final End of Study Visit  
Visit type: office 
Goal: The goal of this visit is to evaluate multiple test programs to minimize energy 
usage and maintain optimal therapy. Selected stimulation programs will be tested and 
documented. To determine the stimulation effect, pain score, satisfaction with 
treatment, global impression of change and physical activity tolerance times may be 
used.). Additionally, information on the outcome and quality of life during Long-term 
Follow-up will be collected and subject’s participation in the study will be concluded. 
12.14 Unscheduled Visit  
Unscheduled visit is any visit that occurs during subject’s participation in the study that is not 
aforementioned.  
Visit type: office  
Goal: Collect the info on the previous period and reason for unscheduled visit, test paresthesia 
thresholds and distribution for selected programs, plan and explain subject’s continuation. Any 
adverse effects and SCS system complaints can be addressed during this visit. 
12.15 Study Completion 
Each subject’s participation in the study will be considered complete upon completion of the 
End of Study Visit or upon subject withdrawal. Upon completing participation in the study 
subjects will continue to be followed per center’s standard of care practice. 
12.16 Source Documents 
It is preferable that original source documents are maintained, when available. In lieu of 
original source documents, certified copies are required to be maintained.  A certified copy is 
a copy (irrespective of the type of media used) of the original record that has been verified (i.e., 
by a dated signature or by generation through a validated process) to have the same 
information, including data that describe the context, content, and structure, as the original. 
Source documentation includes but is not limited to those items noted in Table 12.16-1. 
 
 

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Table 12.16-1: Source Documentation Requirements 
Requirement 
Disposition 
Hospital records or clinical and office charts 
including the evidence of but not limited to 
inclusion/exclusion criteria, informed consent, 
procedures, and assessment of adverse events 
Retain at center 
Programming Pre- and Post-visit Reports 
(program settings, impedance measurements, 
program usage, battery voltage etc) 
Retain at center and send copy to Boston 
Scientific 
Lead Fluoro images 
Retain at center and send copy to Boston 
Scientific 
Clinical evaluations (e.g.NRS, PSWT, PGIC 
etc.) 
Retain at center  
Pain Diary information 
Retain at center and send copy to Boston 
Scientific 
 
13 Statistical Considerations 
13.1 Endpoints 
13.1.1 Primary Endpoint 
Due to the exploratory nature of the study, no prospectively defined, hypothesis driven 
primary endpoint will be defined. 
13.1.1.1 Hypotheses 
No formal hypotheses have been defined. 
13.1.1.2 Sample Size  
The sample size has not been determined in prospective manner. 
13.1.1.3 Statistical Methods 
Descriptive statistics will be employed 
13.1.2 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 

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13.2 General Statistical Methods 
13.2.1 Analysis Sets 
All endpoints described below may be analyzed on both intent-to-treat and a per-protocol 
basis. 
13.2.2 Control of Systematic Error/Bias 
Selection of subjects will be made from the Investigator's usual subject pool. All subjects 
meeting the inclusion/exclusion criteria and having signed the Informed Consent Form will 
be eligible for participation in the study. The reasons for exclusion will be indicated. 
13.2.3 Number of Subjects per Investigative Site 
Up to 10 subjects will be recruited from the single participating site.... 
13.3 Data Analyses 
All data analysis will be performed using standard methods and tools, with appropriate 
validation when needed. Continuous variables will be summarized using descriptive statistics, 
which includes number of non-missing observations, mean, median, standard deviation, 
minimum, maximum or 95% confidence interval. For categorical variables, descriptive 
statistics include frequencies and percentages of categories.  
13.3.1 Other Endpoints/Measurements  
A number of exploratory endpoints are included in this study to explore the effect of 
treatment on 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. Exploratory endpoints will be clearly identified as such in study 
reports. 
13.3.2 Interim Analyses  
No formal interim analyses are planned for the purpose of stopping this study early for 
declaring effectiveness or futility. Handling of drop-outs and missing data will depend on 
their frequency and the nature of the outcome measure. 
13.3.3 Subgroup Analyses 
Subgroup analyses will be carried out as needed in this exploratory study. 
13.3.4 Justification of Pooling 
No analyses to justify pooling of data will be undertaken in this exploratory study. 
13.3.5 Multivariable Analyses 
No formal covariate analyses are planned. 
13.3.6 Other Analyses 
No other formal analyses are planned. 

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14 Data Management 
14.1 Data Collection, Processing, and Review 
The questionnaires & CRF forms collected on paper will be transmitted from the site via fax, mail 
or email and stored on the secure server.  
Paper and/or electronic diaries will be completed by the subject and original paper diaries (if used) 
will be returned and stored at the center. Electronic diaries will be downloaded onto a computer at 
the center to transfer data for later processing. 
14.2 Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain all essential 
study documents and source documentation that support the data collected on the study 
subjects in compliance with applicable regulatory requirements.   
The Principal Investigator or his/her designee will take measures to prevent accidental or 
premature destruction of these documents. If for any reason the Principal Investigator or his/her 
designee 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. Sites are required to inform Boston Scientific in writing 
where paper or electronic files are maintained in case files are stored off site and are not readily 
available. 
14.3 Core Laboratories 
No Core Laboratories will be used in the study. 
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, the reviewing EC, and the regulatory authority if applicable, 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 the corresponding CRF. 
Sites may also be required to report deviations to the EC, and the regulatory authority, per local 
guidelines and national/government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including EC & CA notification, site re-training, or site 
discontinuation/termination) will be put into place by the sponsor. 
The sponsor will not approve protocol waivers. 

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16 Compliance 
16.1 Statement of Compliance 
This clinical investigation is financed by the study sponsor. Before the investigational site can 
be “Authorized to Enroll,” the investigational site must enter into a Clinical Study Agreement 
with the sponsor that details the financing of the study as well as the rights and obligations of 
the investigational site and the investigator. This study will be conducted in accordance with 
ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical 
Practice ethical principles that have their origins in the Declaration of Helsinki, European 
Medical Device Regulation and applicable individual country laws and regulations. The study 
shall not begin until the required approval/favorable opinion from the EC and/or regulatory 
authority has been obtained, if appropriate. Also, the study shall not begin prior to issuance of 
the site Authorization to Enroll, as provided by the sponsor. Any additional requirements 
imposed by the EC or regulatory authority shall be followed, if appropriate.  
16.2 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/, 
the spirit of ISO 14155, ethical principles that have their origins in the Declaration of Helsinki, 
any conditions of approval imposed by the reviewing 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.   
• 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. 
• Report to sponsor, per the protocol requirements, all reportable events. 

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• Report to the EC and regulatory authorities any SAEs and device deficiencies that could 
have led to a SADE and potential USADE, if required by applicable laws or regulations or 
this protocol or by the EC, and supply BSC with any additional requested information 
related to the safety reporting of a particular event. 
• Maintain the device accountability records and control of the device, ensuring that the 
investigational device is used only by authorized/designated users and in accordance with 
this protocol and instructions for use. 
• 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 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, 
including decoding procedures for blinded/masked clinical investigations, 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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• All investigators will provide their qualifications and experience to assume responsibility 
for their delegated tasks 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. 
 
16.2.1 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, are competent to perform the tasks they have been delegated and adequate 
supervision of those to whom tasks are delegated. Where there is a sub-investigator at a site, 
the sub-investigator should not be delegated the primary supervisory responsibility for the site. 
The investigator is accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of the clinical study.  
16.3 Institutional Review Board/ Ethics Committee 
The investigational site will obtain the written and dated approval/favorable opinion of the EC 
for the clinical investigation before recruiting subjects and implementing all subsequent 
amendments, if required. 
A copy of the written EC and/or competent authority (CA) approval of the protocol (or 
permission to conduct the study) and ICF, must be received by the sponsor before recruitment 
of subjects into the study. Prior approval must also be obtained for other materials related to 
subject recruitment or which will be provided to the subject. 
Any amendment to the protocol will require review and approval by the EC before the changes 
are implemented to the study.  All changes to the ICF will be EC approved; a determination 
will be made regarding whether a new ICF needs to be obtained from participants who 
provided consent, using a previously approved ICF.  
Annual EC approval and renewals will be obtained throughout the duration of the study as 
required by applicable local/country laws or regulations or EC requirements. Copies of the 
study reports and the EC continuance of approval must be provided to the sponsor.  
16.4 Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC and will be kept confidential in accordance with all 
applicable laws and regulations. Only authorized BSC personnel and/or a BSC representative 
including, but not limited to Contract Research Organization (CRO), will have access to this 
information. 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, such as overseeing and improving the performance of its device, new medical 
research and proposals for developing new medical products and procedures. All data used in 
the analysis and reporting of this study or shared with a third-party researcher will be without 
identifiable reference to specific subjects. 

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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. 
16.4.1 Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed during implant, testing 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, analyzers, 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 well as operating investigational equipment 
• Performing lead diagnostic testing or determining sensation 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 
investigator verifies and signs the completed form 
• Print out programming reports directly from the programmer and provide original 
to clinical site as source documentation 
• Provide technical expertise/support to subjects during office visits and/or during 
teleconference calls/electronic communications with the principal investigator or 
their delegated site staff and the subject.  
• Programming and maintaining electronic diaries including programming diaries, 
downloading data from diaries, and instructing subjects on the use of diaries and 
troubleshooting diaries. 
• In addition, BSC personnel may perform certain activities to ensure 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 

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• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject  
• Independently collect critical study data (defined as primary or secondary endpoint 
data) 
• Enter data in electronic data capture systems or on paper case report forms 
16.5 Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC for 
subjects in the study will be obtained. 
17 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 sponsor will put a plan in place to document the specific monitoring requirements. 
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. 
18 Potential Risks and Benefits 
18.1 Instructions for Use 
Please refer to the Instructions for Use for an overview of anticipated adverseeffects and risks 
associated with the device(s).   
18.2 Risks associated with Participation in the Clinical Study 
During the study the patients will be treated with different types of stimulation. Patients may 
find certain stimulation parameters to be less effective than others at reducing their pain, and 
they might experience stimulation-related side effects including, but not limited to, muscle 
spasm and discomfort, which the physician will address as per standard of care. This study is 
set up to collect data through questionnaires and diary. To complete these questionnaires, 
patients may spend additional time at the hospital compared to standard of care. Patients may 
have an increased number of visits to the doctor’s office compared to standard of care. Patients 
may find it difficult, uncomfortable or tiresome to complete study visits, the pain diary and/or 
questionnaires.  
Patients who receive the device are subject to the same risks as patients outside of this study 
who receive the same or other similar commercial devices. However, there are additional risks 

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related to the implantation of up to 2 electrodes at the lower level of the spine compared with 
the implantation of the electrodes at the standard level of the spine. In addition, there is also a 
higher risk related to the number of electrodes implanted in the study (up to 4 electrodes) 
compared with the number of electrodes implanted as standard of care (2 electrodes only).  
The physician will explain to the patients the risks of the implant procedure, use of spinal cord 
stimulation and the known and significant interactions associated with the WaveWriterTM 
Technology and other medical procedures. All these are not considered part of the study and 
are done per standard of care.  
18.3 Possible Interactions with Concomitant Medical Treatments, if applicable 
No possible interactions have been identified for use of the SCS system concomitant with any 
specific medications.  
Please refer to the Instructions for Use Manual for procedures that should not be used while 
the SCS system remains implanted. 
18.4 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. 
18.5 Anticipated Benefits 
The reported benefits of the WaveWriterTM SCS System may include: 
• Reduction in the intensity of chronic low back pain 
• Reduction in the intensity of chronic leg pain 
• Improvement in physical functioning (disability) 
• 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) 
18.6 Risk to Benefit Rationale, if applicable 
Based on a risk evaluation the potential benefits provided by the WaveWriterTM SCSTM 
systems to treat chronic intractable pain outweighs residual risks.   
 
19 Safety Reporting 
19.1 Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 

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• All Adverse Events related to Procedure and/or Device (Hardware and/or Stimulation) 
• All Serious Adverse Events regardless of relationship to Procedure, Device Hardware 
or Stimulation 
• All Device Deficiencies 
• Unanticipated Serious Adverse Device Effects 
• New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Any reportable event, experienced by the study subject after informed consent, whether prior 
to, during or subsequent to the procedure, must be recorded in the CRF. 
Underlying diseases and chronic conditions 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 one (1) specific SAE (see  

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Table 19.2-1 for AE definitions). 
Refer to Instructions for Use for the known risks associated with the device(s). 
19.2 Definitions and Classification 
Adverse event definitions are provided in  
 

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Table 19.2-1. Administrative edits were made on the safety definitions from ISO 14155 and 
EU 2017/745for clarification purposes. 
 
 

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Table 19.2-1: Definitions and Classification 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an 
abnormal laboratory finding) in subjects, users or other persons, in the context of a clinical investigation,   
whether or not related to the study medical device and whether anticipated or unanticipated..  
NOTE 1: This includes events related to the study medical device or comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to the study medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse event related to the use of the study   medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies or inadequacies in the instructions 
for use, the deployment, the implantation, the installation, the operation, or any malfunction of the study 
medical device. 
NOTE 2: This definition includes any event resulting from use error from intentional misuse of the study 
medical device. 
NOTE 3: This includes ‘comparator’ if the comparator is a medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, users or other persons as defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, including chronic diseases, or 
3) in-patient hospitalization or prolongation of existing hospitalization, or 
4) 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 foetal distress, foetal death, or a congenital abnormality or birth defect including physical or mental 
impairment.. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigational plan, without a serious deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect (SADE) 
 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. 

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Term 
Definition 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Unanticipated Adverse Device Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
 
Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated 
with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or application), or any 
other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects.   
Unanticipated Serious Adverse Device Effect 
(USADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Serious adverse device effect which by its nature, incidence, severity, or outcome has not been identified in 
the current risk assessment. 
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 assessment. 
Device Deficiency 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
An inadequacy of a medical device related to its identity, quality, durability, reliability, usability, safety or 
performance. NOTE 1: Device deficiencies include malfunctions, use errors, and inadequacy in the 
information supplied by the manufacturer including labelling. 
NOTE 2: This definition includes device deficiencies related to the investigational medical device or the 
comparator. 
The following definitions will be used for defining hospitalization or prolongation of hospitalization for SAE classification purposes: 
Hospitalizations  
Hospitalization does not include: 
• 
emergency room visit that does not result in in-patient admission  
Note: although an emergency room visit does not itself meet the definition for hospitalization, it may 
meet other serious criteria (e.g. medical or surgical intervention to prevent permanent impairment or 
damage) 
• 
elective and pre-planned treatment/surgery for a pre-existing condition that is documented in the 
subject’s record at the time of consent/enrollment 

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Term 
Definition 
• 
admission for social reasons and/or respite care in the absence of any deterioration in the subject’s 
general condition (e.g. subject is homeless, caregiver relief) 
• 
pre-planned, protocol-specified admission related to the clinical study (e.g. procedure required by 
protocol) 
Prolongation of hospitalization  
In-patient admission to the hospital that is prolonged beyond the expected standard duration for the condition 
under treatment. 
Note: new adverse events occurring during the hospitalization are evaluated to determine if they prolonged 
hospitalization or meet another SAE criteria. 
 
19.3 Relationship to Device(s) and/or Study Procedure 
The Investigator must assess the relationship of the reportable AE to the device, (device hardware and/or stimulation) and/or study 
procedure. See criteria in Table 19.3-1.  

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Table 19.3-1: Criteria for Assessing Relationship of Study Device, Stimulation or Procedure to Adverse Event 
Classification 
Description 
Not Related 
Ref: MEDDEV 2.7/3 
Relationship to the device, comparator or procedures can be excluded when: 
- the event is not a known side effect of the product category the device belongs to or of similar devices and procedures; 
- the event has no temporal relationship with the use of the study device or the procedures; 
- the serious event does not follow a known response pattern to the medical device (if the response pattern is previously 
known) and is biologically implausible; 
- the discontinuation of medical device application or the reduction of the level of activation/exposure - when clinically 
feasible – and reintroduction of its use (or increase of the level of activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ not expected to be affected by the device or procedure;  
- the serious event can be attributed to another cause (e.g. an underlying 
or concurrent illness/ clinical condition, an effect of another device, drug, treatment or other risk factors); 
- the event does not depend on a false result given by the study device used for diagnosis, when applicable; harms to the 
subject are not clearly due to use error; 
- In order to establish the non-relatedness, not all the criteria listed above might be met at the same time, depending on the 
type of device/procedures and the serious event. 
Possibly Related 
Ref: MEDDEV 2.7/3 
The relationship with the use of the study device or comparator, or the relationship with procedures is weak but cannot be 
ruled out completely. Alternative causes are also possible (e.g. an underlying or concurrent illness/ clinical condition or/and 
an effect of another device, drug or treatment). Cases were relatedness cannot be assessed or no information has been 
obtained should also be classified as possible. 
Probably Related 
Ref: MEDDEV 2.7/3 
The relationship with the use of the study device, comparator, or the relationship with procedures seems relevant and/or the 
event cannot be reasonably explained by another cause, but additional information may be obtained. 

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Table 19.3-1: Criteria for Assessing Relationship of Study Device, Stimulation or Procedure to Adverse Event 
Classification 
Description 
Causal Relationship 
Ref: MEDDEV 2.7/3 
The serious event is associated with the study device or comparator or with procedures beyond reasonable doubt when: 
- the event is a known side effect of the product category the device belongs to or of similar devices and procedures; 
- the event has a temporal relationship with the study device use/application or procedures; 
- the event involves a body-site or organ that 
-the study device or procedures are applied to; 
-the study device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical device (if the response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the level of activation/exposure) and reintroduction of 
its use (or increase of the level of activation/exposure), impact on the serious event (when clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an effect of another device, drug 
or treatment) have been adequately ruled out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the study device used for diagnosis, when applicable; 
- In order to establish the relatedness, not all the criteria listed above might be met at the same time, depending on the type 
of device/procedures and the serious event. 
 
 
 
 
 
 
 

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19.4 Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in the Table 19.4-1 below.  
Table 19.4-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline post-market 
studies*  
(MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL 
DEVICE VIGILANCE SYSTEM) 
Unanticipated Serious 
Adverse Device Effect 
 
Complete AE CRF page with all 
available new and updated 
information.  
• 
Within 1 business day of first 
becoming aware of the event for 
applicable study*.. 
• 
Terminating at the end of the 
study. 
*Applicable 
study= 
post 
market 
interventional study non-standard of 
care 
Provide all relevant source 
documentation 
(de-identified/ 
pseudonymized) for reported 
event. 
• 
When documentation is available  
• 
Upon request of sponsor 
Serious Adverse Event 
Complete AE CRF page with all 
available new and updated 
information. 
• 
Within 10 calendar 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 
(de-identified/ 
pseudonymized) for reported 
event. 
• 
When 
documentation 
is 
available 
• 
Upon request of sponsor 
Serious 
Adverse 
Device 
Effects* 
Complete AE CRF page with all 
available new and updated 
information. 
• 
Within 3 calendar 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 
(de-identified/ 
pseudonymized) for reported 
event. 
• 
When 
documentation 
is 
available  
• 
Upon request of sponsor 

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Event Classification 
Communication Method  
Communication Timeline post-market 
studies*  
(MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL 
DEVICE VIGILANCE SYSTEM) 
Device 
Deficiencies 
(including but not limited to 
failures, 
malfunctions, and 
product nonconformities) 
Note:  Any 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 
Form with all available new and 
updated information.  
• 
Within 3 calendar days of first 
becoming aware of the event. 
Reporting required through the 
end of the study 
Provide all relevant source 
documentation 
(de-identified/ 
pseudonymized) for reported 
event. 
• 
Upon request of sponsor 
Adverse Device Effects* 
Complete AE CRF 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 30 
business days) after becoming 
aware of the information 
• 
Reporting required through 
the end of study 
Provide all relevant source 
documentation 
(de-identified/ 
pseudonymized) for reported 
event. 
• 
Upon request of sponsor 
*includes events related to device (hardware and/or stimulation) and/or procedure 
The investigator must report Adverse Device Effects, Serious Adverse Events (regardless of 
relationship to device (hardware and/or stimulation) and/or procedure), Unanticipated Serious 
Adverse Device Effects, and Device Deficiencies for each subject from the time of Information 
Consent through the end of study participation.  
The Investigator must assess the potential relationship of all adverse events to the study device 
and/or to study procedures.  
• Adverse events must be assessed according to their relationship to one of the following 
categories: 
o Study Device Related AEs: AEs that can reasonably (i.e. Unlikely, Possibly, 
Probably and Causally Related) be attributed to a study device hardware and/or 
stimulation 
▪ Device Hardware-Related AEs: AEs that can reasonably (i.e. 
Unlikely, Possibly, Probably and Causally Related) be attributed to the 
mere physical presence of the device or to deficiency of the device (i.e., 
an allergic response to device materials).  

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▪ Stimulation-Related AEs: AEs that can reasonably (i.e. Unlikely, 
Possibly, Probably and Causally Related) 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. 
o Procedure Related AEs: AEs that can reasonably (i.e. Unlikely, Possibly, 
Probably and Causally Related) be attributed to a study protocol required 
procedure. 
19.5 Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, product 
nonconformities, and inadequacy in the information supplied by the manufacturer) will be 
documented and reported to BSC. If possible, the device(s) should be returned to BSC for 
analysis. 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. In addition, a Device 
Deficiency paper CRF should be completed.  
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not adverse events. However, an adverse event that results from a device 
failure or malfunction would be recorded as an adverse event on the appropriate CRF. 
Any 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. 
19.6 Reporting to Regulatory Authorities 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. 
20 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 study 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, as applicable. The ICF must be accepted 
by BSC or its delegate (e.g. CRO), and approved by the site’s EC, or central EC, 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 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 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 sign, 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 authority 
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. 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 EC. The new version of the ICF must be approved by the EC. 
Acceptance by Boston Scientific is required if changes to the revised ICF are requested by the 
site’s EC. The EC will determine the subject population to be re-consented. 

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21 Committees 
21.1 Safety Monitoring Process 
The BSC personnel from the Medical Safety and Safety Trial Operation group review safety 
data as it is reported by the sites throughout the duration of the study. During scheduled 
monitoring activities, clinical research monitors further support this review through their 
review of source documents and other data information. The BSC Neuromodulation Medical 
Safety group and Safety Trial Operations team include health care providers with expertise in 
Neurology and Neuromodulation with the necessary therapeutic and subject matter expertise 
to evaluate and classify the events into the categories outlined above. 
22 Suspension or Termination 
22.1 Premature Termination of the Study 
Boston Scientific reserves the right to terminate the study at any stage but intends to exercise 
this right only for valid scientific or business reasons and reasons related to protection of 
subjects.  Investigators, associated ECs, and regulatory authorities, as applicable, will be 
notified in writing in the event of study termination. 
22.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the following: 
•  
• Suspicion of an unacceptable risk, including serious health threat. In this case, the sponsor 
shall suspend the clinical investigation while the risk is assessed. The sponsor shall 
terminate the clinical investigation if an unacceptable risk which cannot be controlled is 
confirmed. 
• Instructions by the IRB/EC/REB or regulatory authorities to suspend or terminate the 
clinical investigation. 
• 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/marketing of the device. 
22.2 Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval 
Any investigator, or associated EC, or regulatory authority may discontinue participation in 
the study or withdraw approval of the study, respectively, with suitable written notice to Boston 
Scientific. Investigators, associated ECs, and regulatory authorities, as applicable, will be 
notified in writing in the event of these occurrences. 
22.3 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 

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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 EC terminates participation in the study, participating investigators, associated 
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 
devices, if supplied by Boston Scientific, unless this action would jeopardize the rights, safety, 
or welfare of the subjects. 
22.4 Criteria for Suspending/Terminating a Study Site 
Boston Scientific reserves the right to stop the inclusion of subjects at a study site at any time 
after the study initiation visit if no subjects have been enrolled for a period beyond 3 months 
after site initiation, or if the site 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 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 EC and regulatory authorities, as applicable, will be notified. 
Study participants will be contacted, as applicable, and be informed of changes to study visit 
schedule. 
23. Study Registration and Results 
23.1 Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
accessible database. 
23.2 Clinical Investigation Report 
Study results will be made available in accordance with the legal requirements and the 
recognized ethical principles, in accordance with the Boston Scientific Policy. A Clinical 
Investigation Report will be made available to all investigators, IRB/EC/REB and regulatory 
authorities, as applicable in accordance with the Boston Scientific Policy and local 
requirements.  As applicable an abbreviated Clinical Investigation Report will be made 
available on a publicly accessible database. 
 

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23.3 Publication Policy  
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. BSC will submit study results 
for publication (regardless of study outcome) following the conclusion or termination of the 
study. Boston Scientific 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) and/or Executive/Steering 
Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
• The data, analytic methods, and study materials for this clinical trial may be made available 
to other researchers in accordance with the Boston Scientific Data Sharing Policy 
(https://www.bostonscientific.com). 
24. Reimbursement and Compensation for Subjects 
24.1 Subject Reimbursement 
Travel and other expenses incurred by subjects as a result of participation in the study will be 
reimbursed in accordance with pertinent country laws and regulations and per the study site’s 
regulations.   
24.2 Compensation for Subject’s Health Injury 
Boston Scientific will purchase an insurance policy to cover the cost of potential health injury 
for study subjects, if required by applicable law.  
25. Bibliography 
Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 
10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 
24-month results of a prospective multicenter study. Pain Med. 2014 Mar;15(3):347-54. 
Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 
20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67.    
Carter ML. Spinal cord stimulation in chronic pain: a review of the evidence. Anaesth Intensive 
Care. 2004 Feb;32(1):11-21. 

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De Ridder D, Vanneste S, Plazier M, van der Loo E, Menovsky T. Burst spinal cord 
stimulation: toward paresthesia-free pain suppression. Neurosurgery. 2010 May;66(5): 
986-90. 
Dmitrienko A, Offen W, Westfall W. Gatekeeping strategies for clinical trials that do not 
require all primary effects to be significant. Stat Med. 2003 Aug; 22(15):2387-400. 
Dmitrienko A, Tamhane AC, Wiens BL. General multistage gatekeeping procedures. Biom J. 
2008 Oct;50(5): 667-77. 
Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, 
Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical 
importance of group differences in chronic pain clinical trials: IMMPACT 
recommendations. Pain. 2009 Dec; 146(3):238-44. 
Epstein LJ, Palmieri M. Managing chronic pain with spinal cord stimulation. Mount Sinai 
Journal of Medicine: A Journal of Translational and Personalized Medicine. 2012 Jan 
1;79(1):123-32. 
Falowski S, Celii A, Sharan A. Spinal cord stimulation: an update. Neurotherapeutics. 2008 
Jan 1;5(1):86-99. 
Grabois M. Management of chronic low back pain. Am J Phys Med Rehabil. 2005 Mar; 84(3 
Suppl):S29-41. 
Kumar K, Hunter G, and Demeria D. Spinal cord stimulation in treatment of chronic benign 
pain: challenges in treatment planning and present status, a 22-year experience. 
Neurosurgery. 2006 Mar;58(3):481-46; discussion 481-96. 
Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, 
Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. The effects of 
spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the 
prospective randomized controlled multicenter trial of the effectiveness of spinal cord 
stimulation. Neurosurgery. 2008 Oct;63(4):762-70; discussion 770. 
Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, 
Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. Spinal cord 
stimulation versus conventional medical management for neuropathic pain: a 
multicentre randomised controlled trial in patients with failed back surgery syndrome. 
Pain. 2007 Nov;132(1-2):179-88. 
Levine AB, Steven DA, Parrent AG, MacDougall KW. Successful long-term nerve root 
stimulation for chronic neuropathic pain: a real world, single center Canadian 
experience. Pain physician. 2017 Feb 1;20:95-106. 
McPherson ML. Demystifying opioid conversion calculations: a guide for effective dosing. 
Bethesda: American Society of Health-System Pharmacists; 2009. 

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North RB. Spinal cord stimulation for intractable pain: long-term follow-up. J Spinal Disord. 
1990 Dec;3(4):356-61. 
North RB, Ewend MG, Lawton MT, and Piantadosi S. “Spinal cord stimulation for chronic, 
intractable pain: superiority of “multi-channel” devices”, Pain. 1991 Feb;44(2);119-30. 
Oakley J, Prager JP, Stamatos J, Foster AM. A new spinal cord stimulation system effectively 
relieves chronic, intractable pain:  a multicenter prospective clinical study. 
Neuromodulation. 2007 Jul;10(3):262-78. 
Perruchoud C, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet 
N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E. Analgesic efficacy 
of high-frequency spinal cord stimulation: a randomized double-blind placebo-
controlled study. Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. 
Pyles S, Lechleiter K, Chen L, Jain R. Surgical Technique and Clinical Outcome for Targeted 
Dorsal Nerve Root Neurostimulation for use in the Treatment of Chronic Foot and/or 
Ankle Pain. Poster presented at: 16th Annual Pain Medicine Meeting: Leading with 
Quality; 2017 Nov 16-18; Lake Buena Vista, FL. 
Sears NC, Machado AG, Nagel SJ, Deogaonkar M, Stanton-Hicks M, Rezai AR, & Henderson 
J M. Long-term outcomes of spinal cord stimulation with paddle leads in the treatment 
of complex regional pain syndrome and failed back surgery syndrome. 
Neuromodulation. 2011 Jul-Aug;14(4):312-18; discussion 318. 
Taylor RS, Taylor RJ, Van Buyten JP, Buchser E, North R, Bayliss S. The cost effectiveness 
of spinal cord stimulation in the treatment of pain: a systematic review of the literature. 
J Pain Symptom Manage. 2004 Apr;27(4):370-8. 
Thomson SJ, Tavakkolizadeh M, Love‐Jones S, Patel NK, Gu JW, Bains A, Doan Q, Moffitt 
M. Effects of rate on analgesia in kilohertz frequency spinal cord stimulation: results of 
the PROCO randomized controlled trial. Neuromodulation: Technology at the Neural 
Interface. 2018 Jan 1;21(1):67-76. 
Van Buyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord 
stimulation for the treatment of chronic back pain patients: results of a prospective 
multicenter European clinical study. Neuromodulation. 2013 Jan-Feb;16(1):59:65; 
discussion 65-6. 
26. Abbreviations and Definitions  
26.1 Abbreviations 
Abbreviations are shown in Table 0-1.  

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Table 0-1: Abbreviations 
Abbreviation/Acronym 
Term 
AE 
Adverse Event 
BSC 
Boston Scientific Corporation 
BSN 
Boston Scientific Neuromodulation 
CA 
Competent Authority 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DC 
Dorsal Column 
DR  
Dorsal Root 
EC 
Ethics Committee 
ETS 
FBSS 
External Trial Stimulator 
Failed Back Surgery Syndrome 
FDA 
Food and Drug Administration 
HCP 
Health Care Personnel 
ICF 
Informed Consent Form 
ICH 
International Committee on Harmonization 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
IFU 
Independent Ethics Committee 
Instructions For Use 
IPG 
Implantable Pulse Generator 
ISO 
International Standards Organization 
MEDDEV 
MICC 
NRS 
ODI 
PGIC 
PSWT 
Medical Device Directives 
Multiple Independent Current Control 
Numeric Rating Scale 
Oswestry Disability Index 
Patient Global Impression of Change 
Patient Satisfaction With Treatment 
SADE 
Serious Adverse Device Effect 
SAE 
SCS 
VAS 
Serious Adverse Event 
Spinal Cord Stimulation 
Visual Analog Scale 
 
 
 
 
 
 
 
 
 
 

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26.2 Definitions 
Terms are defined in Table 0-1.  
Table 0-1: Definitions 
Term 
Definition 
Electrical Mapping  
A series of measurements of stimulation sensory thresholds, stimulation 
induced paresthesia drawings which are intended to assist in determining 
the clinically optimal stimulation parameters for perception and 
subperception SCS 
Enrollment 
A patient is considered to be enrolled as a research subject in the study 
after informed consent is obtained. 
Source Data 
All information in original records of clinical findings, observations, or 
other activities in a clinical investigation, necessary for the reconstruction 
and evaluation of the clinical investigation. Note 1 to entry: This includes 
source data initially recorded in an electronic format. 
Source Document 
 Original or certified copy of printed, optical or electronic document 
containing source data. 
Subject 
Patient who is enrolled to participate in the study, study participant