Precision Novi

Spinal Cord
Stimulator
System
April, 2016

Nick Shiels & Soroush Yaghini

BMDV 6131

Table of Contents
Introduction.....................................................................................................3
Point of Contact Information............................................................................3
Survey Questions............................................................................................3
Device Information..........................................................................................4
Theory of Operation........................................................................................4
Preventative Maintenance...............................................................................5
Specifications and Technical Data (Boston Scientific, 2016)...........................5
Parts and Description......................................................................................7
Operating Errors..............................................................................................8
Device Testing.................................................................................................8
Study #1................................................................................................................. 8
Study #2................................................................................................................. 9

Warnings for Use.............................................................................................9

Warnings to Patients............................................................................................... 9
Warnings to Physician........................................................................................... 10

Recalls...........................................................................................................11
Competitors...................................................................................................11
Conclusion.....................................................................................................11
References....................................................................................................11

Table of Figures
Figure
Figure
Figure
Figure
Figure

1:
2:
3:
4:
5:

Survey Questions.............................................................................3
Output Ranges of Pulse Generator...................................................5
Maximum Current Amplitude per Electrode Versus Impedance.......6
Maximum Amplitude Based on Frequency and Pulse Width.............6
The Precision Novi Kit and Contents.................................................7

Introduction
The following is a report on the Precision Novi Spinal Cord Stimulator. This
document will cover topics such as theory of operation, clinical and technical
need to know information, a survey/questionnaire with a company employee,
and some important warnings to both the physician and the patient.

Point of Contact Information

Main Media Relations Contact Channel media@bsci.com
Nisha Deo, Media Relations Nisha.Deo@bsci.com

Survey Questions
Questions
Answers/Ratings
Which geographical location is the
Open Ended Answer
device manufactured in?
Was there a team or a particular
Open Ended Answer
employee of the R&D division
responsible for it?
The industry is moving towards
Disagree Somewhat
Agree
smaller and non-reusable devices.
The licensing for such a device is
Disagree Somewhat
Agree
typically very difficult compared to
other medical devices.
Were there any ethical considerations
Disagree Somewhat
Agree
for such a device?
Was it difficult to get it licensed in
Disagree Somewhat
Agree
Canada compared to other countries?
Is there a variety of different
Disagree Somewhat
Agree
subsidized financial models for this
device in different countries or fairly
similar?
Is this segment of devices saturated in Disagree Somewhat
Agree
terms of Research & Development?
The clinical trials went smoothly.
Disagree Somewhat
Agree
The device is sold at a cost which is
Disagree Somewhat
Agree
close to the manufacturing cost.
Figure 1: Survey Questions

Device Information
CLASS: class IV
Manufacturer: Boston Scientific Neuromodulation Corporation
Footprint: Smallest 16 contact stimulator measuring 3 cubic inches x 11
millimeters thick
License Number: 9544
Application Date: March 31st, 2015
Approval Date: October 20th, 2015

Theory of Operation
The Precision Novi spinal cord stimulator is an implantable, permanent spinal
chord stimulator. The system consists of an Implantable Pulse Generator
(IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads,
Lead Extensions, OR Cables, Remote Control, Clinician Programmer, and
Programming Wand, each packaged as a separate kit.
This type of device is used to relieve body pain in the back, arms, and legs
by a means of sending electrical impulses through the spinal cord nerves. It
is believed that by doing so pain signals can be stopped from being received
by the brain.
To implant the stimulator system, first a small incision is made into the lower
back, then by using and epidural needle inserted into the spine one or more
wire leads a fed up the spine through the epidural space. The leads then
send the electrical impulses through the spinal nerves on order to stimulate
them and block pain signals from reaching the brain. The pulse
generator/battery is also implanted into the body via a small incision. It is
commonly placed in the buttocks or the abdominal regions. The Precision
Novi system has a new, more compact design that makes it more
comfortable for its users.
After the system has been implanted the stimulators electrical pulses can be
programmed using an external wireless device. The user is then in control of
the electrical impulses and the can turn stimulations on or off, adjust the
power level, and switch between different programs. Unlike any other spinal
cord stimulation system, the Precision Novie features a three dimensional
neuro targeting software incorporates three-dimensional lead location, as
well as the conductivity of the spinal cord and surrounding tissue. This new
advanced technology automatically calculates the optimal programming
configuration to target the selected pain area. Further, unique for primary
cell devices, Precision Novi is a multi-wave platform capable of delivering a

variety of signal shapes and waveforms, including burst and higher rate
frequencies.

Preventative Maintenance
Primarily battery driven which means that over time the battery may
need to be replaced due to overuse. In some instances, the battery has
ruptured, in this case seek medical attention immediately as the battery
chemicals are harmful. can lead to replacement of the battery pack. In terms
of calibration, the device is fully calibrated after the insertion procedure by a
physician, from then on it is user adjustable and may require mild calibration
down the road in terms of usage.

Specifications and Technical Data (Boston Scientific,

2016)
The following table and graphs shows technical information regarding the
output pulses of the pulse generator for the Precision Novi System.

Parameter
Areas
(Channels)
Amplitude
Rate
Width
Cycle
Ramp ON

Range

Default

0 25.5 mA
0 mA
2 1200 ppsa
40 pps
20 1000 secb
210 sec
1 sec 90 min, OFF
OFF
1 10 sec
3 sec
1 16, case: +100% to -100%, 1 16, case:
Contacts
OFF
OFF
Figure 2: Output Ranges of Pulse Generator

Figure 3: Maximum Current Amplitude per Electrode Versus

Impedance

Figure 4: Maximum Amplitude Based on Frequency and Pulse Width

Parts and Description

C
)

B
)
A)

D
)

Figure 5: The Precision Novi Kit and Contents

(A)Implantable Pulse Generator (IPG) The pulse generator is the
device responsible for delivering the therapeutic pulses through the
percutaneous leads. It is capable of delivering pulses of different
formations and intensity. It can also deliver the pulses in different
locations along the leads in order to stimulate therapeutic relief
responses in different parts of the body.
(B)Remote Control The remote control is the hand held device that
allows the patient equipped with the Precision Novi to have full control
over the pulses they are receiving. The remote is a wireless device that
is used for turning the pulses on or off, cycling through different preprogrammed pulse modalities to alter where they receive the
therapeutic relief, and controlling the intensity or frequency of the
pulses.
(C)Clinical Programmer The Clinical programmer is the device that
the clinician will use while working with the patient to determine the
best modalities of the Precision Novi to use with the patient to receive
the optimal amount of pain relief. With the programmer the clinician is
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able to pre-program the modalities that the patient is able to switch

between using the wireless remote control. They are able to set the
location of the pulses, amplitude, frequency, and duration. A new
technology that is introduced into the Precision Novi Programmer is a
software that has the ability to automatically detect the locations
where the patient requires the therapy in order to provide a faster
more accurate diagnosis and set-up of the system with the patient.
(D)
Percutaneous Leads The leads are the emitter of the pulses
that are placed within the spine in the epidural space next to the
nerves. A new innovation with the leads equipped with the Precision
Novi is the new design of 360 degree electrodes to provide more nerve
stimulation and and a more accurate delivery of the pulses to achieve
stimulation in the desired locations.

Operating Errors
Changes in your posture can either amplify or decrease the efficiency
of the stimulation signals. Environmental interference may also affect the
implantable device to varying degrees (such as proximity to high magnetic
forces) although modern implantable devices have more efficient shielding to
prevent such interference.
User negligence can also contribute to the device either not delivering
sufficient signal strength or too much leading to discomfort. User education
and instruction on how to utilize the patient-adjustable remote is necessary.

Device Testing
Studies for the Precision Novi were conducted during two studies on a total of
116 patients implanted with the SCS system. Throughout the studies a total
of approximately 3166 months of device operation were analyzed between
all patients for the evaluation.

Study #1
The first study examined the effectiveness of the device on patients who
were suffering from chronic pain in their abdominal areas, back, and legs,
either due to post surgery pain or strenuous chronic pain. The purpose of the
study was to examine the long term effectiveness of the Precision Novi SCS
on chronic pain. Patients implanted with the system were evaluated at 6
weeks, 12 months, and 24 months during follow-ups with a physician. After
the 24-month period patients described that their pain was significantly
improved. 25% of patients reported that their pain relief improved by a
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minimum of 50%. Throughout the study there were problems with a small
group of patients. A total of 3 patients in this study had to have their
stimulators repositioned due to pain in the original location. One patient had
their SCS removed due to an infection but had a new Novi system implanted
as a replacement. Lastly, a total of two patients unfortunately had the
Precision Novi SCS removed due to unsatisfactory pain relief.

Study #2
Another study that was performed was conducted on patients primarily with
Failed Back Surgery Syndrome but other patients also had Complex Regional
Pain Syndrome, Neuropathic Pain Syndrome, and some were survivors of a
previous stroke. Initially these patients were tested with a set of temporary
leads for a period of 6 weeks, by then if the patient reports a reduction of
pain by at least 50% then an implant of the Precision Novi was made for a
more extensive time period. 66% of the patients who were equipped with the
temporary SCS reported a 50% reduction in pain and were then implanted
with permanent implants. After a long term follow up after a period of 34
months, a total of 89% of patients reported that their pain was drastically
decreased by a minimum of 50%. Throughout this study it was recorded that
one patient required a replacement SCS due to an electrode fracture,
another required a replacement due to an infection at the insertion site, and
a total of 59% of patients required repositioning procedures.

Warnings for Use

Warnings to Patients
Magnetic Resonance Imaging (MRI) - The Precision Novi System has not
been evaluated for safety and compatibility in the MR environment.
Introducing a patient with this device into an MRI scanner may result in
severe patient injury, death, or device malfunction. Patients who are
equipped with a Precision Novi device should never be exposed to an MR
environment. Exposure may result in damage to patient tissue, dislodgement
of part or components, heating of the neurostimulators, voltage induction
causing an uncomfortable jolt to the patient due to damaged components.
Pediatric Use - The safety and effectiveness of spinal cord stimulation has
not been established for pediatric use.
Diathermy Due to Shortwave, microwave and/ or therapeutic ultrasound,
diathermy should not be used on patients equipped with the Precision Novi
SPS. The energy generated by diathermy can be transferred through the
stimulator system, causing tissue damage at the lead site resulting in severe
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injury or death. Damage to the system may occur weather the system is
turned on or off.
Implanted Stimulation Devices - The effects of implanted stimulation
devices on neurostimulators is unknown but spinal cord stimulators have
been known to interfere with the operation of other implanted stimulators
such as pacemakers or cardioverter defibrillators.
Stimulator Damage - Patients may receive burns due to exposure of
battery chemicals if the pulse generator implant becomes ruptured or
pierced by sharp objects.
Postural Changes - Patients should be advised that changes in posture or
abrupt movements may cause decreases, or painful increases in the
stimulation level. Patients should be advised to turn down the amplitude or
turn off the IPG if they are aware they will be maneuvering in awkward
positions or making abrupt movements. If unpleasant sensations occur, the
IPG should be turned off immediately.
Electromagnetic Interference - Strong electromagnetic fields can
potentially affect the Precision Novi system and cause it to turn off, or cause
a jolt of stimulation that can be painful. Patients should be cautious when
they are around devices such as:
Theft detectors or security screeners
Power lines or power generators
Electric steel furnaces and arc welders
Large, magnetized stereo speakers
Tag deactivators such as those found in retail stores

Warnings to Physician
Implanted Stimulation Devices Before the Novi spinal cord is decided to
be placed within the patient it is important that a careful screening of the
patient must be performed in order to conclude that the stimulator will
provide safe results.
Postural Changes - Postural changes may affect stimulation intensity.
Instruct patients to keep the Remote Control on hand at all times, and ensure
that they understand how to adjust stimulation levels and what types of
positions may negatively effect the stimulations.
Medical Devices/Therapies Other types of therapies may negatively
affect the operation of the Novi spinal cord stimulator such as lithotripsy,
electrocautery, external defibrillation, radiation therapy, ultrasonic scanning,
high-output ultrasound, X-Ray or CT Scan:

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Turn off stimulation at least five minutes before the procedure or

application.
All equipment, including ground plates and paddles, must be
used as far away from the IPG
as possible.
Every effort should be taken to keep fields, including current,
radiation, or high-output
ultrasonic beams, away from the IPG.
Equipment should be set to the lowest energy setting clinically
indicated.
Instruct patients to confirm IPG functionality following treatment
by turning on the IPG and
gradually increasing stimulation to the desired level.

Recalls
None noted as of the time of this report.

Competitors
There are only two other major manufacturers of spinal cord stimulators
besides Boston Scientific.
Medtronic, founded in 1949 and based in the USA.
St. Jude Medical, founded in 1976 and based in the USA.

Conclusion
The Boston Scientific Precision Novi Spinal Cord Stimulator is a glimpse
into the future of implantable SCS devices. Its thin and small design is a leap
forward in terms of patient comfort and efficiency. The less noticeable an
implantable object is the greater the quality of life of the patient.
Spinal cord stimulators continue to make large advances as it is seen
as an emerging technique to decrease and potentially even neutralize
chronic pain suffered by patients in their back and limbs.

References
Precision NoviTM System Information for Prescribers. (2015). In Bostonscientific.com.
Retrieved from https://www.bostonscientific.com/content/dam/Manuals/us/current-reven/91005929-01RevB_Precision_Novi_Information_for_Prescribers_DFU_en-US_S.pdf

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Precision NoviTM Implantable Pulse Generator: Directions for Use. (2015). In

bostonscientific.com. Retrieved from
https://www.bostonscientific.com/content/dam/Manuals/us/current-rev-en/9100592601RevC_Precision_Novi_IPG_DFU_en-US_S.pdf
Precision Novi Primary Cell Spinal Cord Stimulator System. (n.d.). In bostonscientific.com.
Retrieved from http://www.bostonscientific.com/en-EU/products/spinal-cord-stimulatorsystems/precision-novi.html
Regulatory Decision Summary: PRECISION NOVI SPINAL CORD STIMULATOR SYSTEM
(2015, November 3). In http://www.hc-sc.gc.ca. Retrieved from http://www.hc-sc.gc.ca/dhpmps/prodpharma/rds-sdr/mdim/rds_sdr_precision_novi_spinal_cord_stimulator_system_237922-eng.php

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