Document 1 - FOI 4904
s22
s22
From: s22
@health.gov.au>
Sent: Tuesday, 13 September 2022 3:57 PM
ACT 1982
To: s22
@health.gov.au>
Subject: RE: TGA/TAAD matters [SEC=OFFICIAL]
Hi s22
HEALTH AND AGED CARE
I have attached the ACMD paper attachments in‐confidence.
INFORMATION
I’d be very interested in having a look at the TAAD Utilisation review, in confidence.
I’ll ask s22
and s22 if they would like to/are available to join the meeting.
Thanks
s22
FREEDOM OF
THIS DOCUMENT HAS BEEN RELEASED UNDER
THE
s22
BY THE DEPARTMENT OF
s22
Devices Post Market Reforms & Reviews Section
Medical Devices and Product Quality Division | Health Products Regulation Group
Medical Devices Surveillance Branch
Australian Government Department of Health and Aged Care
T: 02 6289 s22 M: s22
| E: s22
@health.gov.au
1
Page 1 of 5
Document 1 - FOI 4904
Location: Perth
PO Box 100, Woden ACT 2606, Australia
The Department of Health acknowledges the Traditional Custodians of Australia and their continued connection to land, sea and community. We pay our respects to all
Elders past and present.
From: s22
@health.gov.au>
Sent: Tuesday, 13 September 2022 3:23 PM
To: s22
@health.gov.au>
Subject: RE: TGA/TAAD matters [SEC=OFFICIAL]
Sounds good.
I’ll send an invite.
UNDER CARE
Re the ACMD submission, could I also look at Attachments 3 and 4? (I have 1&2: the Cochrane review and the Jones et al article).
I’ll send you the TAAD Utilisation review, in confidence, FYI. Just in the interests of improving the TAAD/TGA
1982 interface. We elaborated on TGA’s feedback on the Jones et al
AGED
study following a discussion with s22
, alongside an analysis of Casemix and MBS data. ACT
The way we integrate our respective pieces of work to get the best whole‐of‐system outcome is the next phase of the discussion…
RELEASED AND
Do you think s22
would like to be invited to this meeting?
BEEN
From: s22
@health.gov.au>
HEALTH
Sent: Tuesday, 13 September 2022 2:53 PM
HAS
OF
To: s22
@health.gov.au>
INFORMATION
Subject: RE: TGA/TAAD matters [SEC=OFFICIAL]
OF
Hi s22
Tuesday 18 will work for me – will 10am suit you?
DOCUMENT
Thanks
FREEDOM
DEPARTMENT
s22
THIS THE
THE
s22
BY
s22
Devices Post Market Reforms & Reviews Section
Medical Devices and Product Quality Division | Health Products Regulation Group
Medical Devices Surveillance Branch
Australian Government Department of Health and Aged Care
T: 02 6289 s22 M: s22
| E: s22
@health.gov.au
2
Page 2 of 5
Document 1 - FOI 4904
Location: Perth
PO Box 100, Woden ACT 2606, Australia
The Department of Health acknowledges the Traditional Custodians of Australia and their continued connection to land, sea and community. We pay our respects to all
Elders past and present.
From: s22
@health.gov.au>
Sent: Tuesday, 13 September 2022 2:10 PM
To: s22
@health.gov.au>
Subject: RE: TGA/TAAD matters [SEC=OFFICIAL]
Many thanks s22
.
How about the week after ACMD, week beginning 17 Oct, for a meeting?
UNDER CARE
Tues – Thurs before 3pm works best for me. Do you have a preferred timeslot?
s22
1982
AGED
ACT
RELEASED AND
From: s22
@health.gov.au>
Sent: Tuesday, 13 September 2022 12:49 PM
BEEN
To: s22
@health.gov.au>
HEALTH
Subject: RE: TGA/TAAD matters [SEC=OFFICIAL]
HAS
OF
INFORMATION
Hi s22
OF
I’d be happy to meet with you and s22
next month after ACMD and also OK to share, in confidence, the ACMD paper on spinal cord stimulators (attached).
Thanks
s22
DOCUMENT
FREEDOM
DEPARTMENT
s22
THIS
THE THE
s22
Devices Post Market Reforms & Reviews Section
BY
Medical Devices and Product Quality Division | Health Products Regulation Group
Medical Devices Surveillance Branch
Australian Government Department of Health and Aged Care
T: 02 6289 s22 M: s22
| E: s22
@health.gov.au
Location: Perth
PO Box 100, Woden ACT 2606, Australia
3
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UNDER CARE
1982
AGED
ACT
RELEASED AND
BEEN HEALTH
HAS INFORMATION
OF
OF
DOCUMENT
FREEDOM
DEPARTMENT
THIS
THE THE
BY
Document 1 - FOI 4904
UNDER CARE
1982
AGED
ACT
RELEASED AND
BEEN HEALTH
HAS INFORMATION
OF
OF
DOCUMENT
FREEDOM
DEPARTMENT
THIS
THE THE
BY
5
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SPINAL CORD STIMULATORS
SYSTEMATIC REVIEWS SUMMARIES
1. A review of spinal cord stimulation systems for chronic pain (Verrills, 2016) AUSTRALIAN
STUDY
TGA Assessor summary:
• The most recent systematic and comprehensive review of the effectiveness of SCS in
treating chronic spinal pain demonstrated that there is a significant (Level I–II) evidence for
SCS as a treatment for lumbar FBSS, where conventional medical management has failed.
• Furthermore, there is now Level I evidence for high-frequency stimulation but only limited
evidence for burst stimulation.
• In another recent and extensive review and meta-analysis of conventional SCS, more than
half of all patients experienced significant pain relief. The authors observed that
CARE
this was
UNDER
maintained for a mean follow-up period of 24 months.
•
1982
These reviews above demonstrate that traditional SCS is an effective treatment option for a
AGED
cohort that is notoriously difficult to treat.
ACT
• The literature, when viewed historically, must be tempered by
AND the developments in skills,
RELEASED
application, and technological advances.
o Hence, the traditional SCS papers have often reported successful pain relief as an
BEEN
undifferentiated generic pain that is not specific
HEALTH to the site of the primary or
greatest pain (eg, back or leg).
HAS
INFORMATION
OF
o This observation is important because conventional SCS therapy has historically
OF
been prescribed for limb pain and has had only limited success in managing back
pain.
o Recent studies that have included back pain as the primary source have involved
DOCUMENT
HF10 therapy at 10,000 Hz; this therap
DEPARTMENT y has evolved to better capture significant
FREEDOM
back, leg,
THIS and radicular pain.
•
THE
Tolerance to SCS has be
THE en observed in patients where pulse amplitude needs to be
increased to achieve
BY the same analgesic benefit over time and/or efficacy has been lost.
o Tolerance cannot be predicted
o Data pertaining to HF10 SCS have demonstrated no tolerance at this point.
• Despite strict criteria for patient selection, a substantial number of patients fail to achieve
optimal pain relief with SCS.
o A number of factors have been identified as possible indicators for treatment failure
including tobacco and drug use, age, and lengthy delay between times of original
pain onset to SCS implant.
• DRG SCS has been demonstrated as effective in multiple etiologies, including FBSS, CRPS,
and chronic postsurgical pain.
o A recent study reported 1 year outcomes for DRG with overall pain scores reducing
from 77.6 to 33.6 (P<0.005)
o Back pain reduced from 74.5 to 39.7 (P<0.05), and leg pain reduced from 74.6 to
28.7 (P<0.0005).
Page 1 of 11
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o The most compelling pain reduction happened for foot pain with scores reducing
from 81.4 to 22.0 (P<0.05).
o Approximately 60% of the DRG SCS patients reported >50% improvement in their
pain, and the pain localized to the back, legs, and feet was reduced by 42%, 62%,
and 80%, respectively.
o Other outcome parameters including quality of life, mood, and satisfaction were
improved and maintained throughout the 12 months.
• The Accurate study is a US pivotal RCT between DRG SCS and traditional SCS Medtronic
system
o The largest RCT in the history of CRPS and causalgia, running from 2013 with primary
completion estimated for 2018.
o The sample size for the study is 152; with 76 randomized to DRG SCS and 76 to the
control arm using Medtronic traditional SCS.
o Superiority was demonstrated in the DRG SCS group with 81% of patients achieving
>50% pain reduction and meeting the primary endpoint at the 3-month mark, and
74% maintaining that primary endpoint at 12-month follow-up.
o The traditional SCS arm demonstrated 56% of patients having >50% pain reduction
at 3 months and 53% maintaining this through 12 months. CARE
o It was noted that 70% of patients achieved >80% pain red
UNDER uction in the DRG group
versus 52% in the Medtronic group.
1982
•
AGED
The Sunburst study ran from 2013-2016.
o It is a prospective randomized, non-inferiority con
ACT trolled trial
AND
o
RELEASED
Patients who required to have pre-existing pain scores >6/10 and a >50% pain
reduction in a traditional SCS trial using tonic stimulation.
o The sample size for the study was 12
BEEN 1 with 100 people randomized.
HEALTH
o Analysis demonstrated superiority for burst stimulation over tonic stimulation
HAS
OF
• The Senza RCT is a Level I study design run from 2012
INFORMATION -2015
o This is the first-ever RCT of two SCS therapies with patients randomized to HF10 SCS
OF
(Senza System) or traditional SCS commercially available, Precision Plus SCS system
o 198 patients were randomized with 101 to the HF10 SCS group and 97 to traditional
o Of these, 90 HF10 SCS pati
DOCUMENT ents and 81 traditional SCS patients were subsequently
DEPARTMENT
implanted. FREEDOM
THIS
o The primary endpoint of >50% back pain reduction at 3 months was achieved in
THE THE
80.9% of the HF10 SCS group versus 42.5% of the traditional SCS group This met the
BY
criteria; At 12 months, this primary endpoint was met in 78.7% versus 51.3% of the
patients.
o Similarly, the primary endpoint for leg pain reduction was met in 80.0% of the HF10
SCS group versus 49.4% of the traditional SCS group
o The responder rates for >50% leg pain reduction at 3 months was 83.1% in the HF10
SCS group and 55.0% in the traditional SCS group. The 12-month outcome data for
the same groups were 78.7% versus 51.3%
o This study demonstrated superiority of HF10 SCS to traditional SCS in all primary and
secondary endpoints that has led to the labeling of HF10 therapy as superior to
traditional low-frequency SCS by the FDA
Economical or cost efficiency
Page 2 of 11
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• Cost-efficacy studies show that despite significant initial costs, SCS compared with other
conventional treatments available to chronic pain patients results in long-term reductions in
health care costs, which offset the high initial treatment costs over time.44
Safety and tolerability
• In the literature, SCS is reported as a safe procedure due to its reversible and minimally
invasive characteristics.
• Although catastrophic complications are possible, they are very rare.
• However, the incidence of minor complications of SCS has a higher incidence
• The complications are divided into three main categories: mechanical, biological, and
technique-related.
o Complications of a mechanical origin are more common than those of biological
origin.
o Incidence of minor complications 30-40% (readily reversible and generally resolved).
o Hardware related complications 24-50%
o Mechanical complications eg lead fracture or disconnection 5-9%
o Lead migration 0-27%; migration requiring intervention in <5%
o Implantable pulse generator failure occurred at a reported frequency of 1.7%
UNDER CARE
o These complications are minimised by using the appropriate lead, anchoring and
suturing techniques; minimising patient movement in fir
1982 st 3 months to allow
AGED
scarring to form around leads
ACT
• One study demonstrated that lead migration of significance an
AND d requiring intervention in
RELEASED
both the HF10 and traditional SCS arms occurred <5%. This most likely reflects
improvements in both lead design and the anchoring systems used
•
BEEN
Biological complications include infection, allergic reactio
HEALTH n, pain at implant site, implantable
pulse generator seroma, epidural fibrosis, epidural hematoma, dural puncture, and, rarely,
HAS INFORMATION
OF
neurological injury.
o The most common biological co
OF mplication is infection with a rate between 3% and
8%, and the majority of these are superficial.
o The occurrence of dural puncture is reported as between 0.3% and 2%.
DOCUMENT
o Other adverse biological events such as epidural fibrosis, compressive phenomenon,
FREEDOM
DEPARTMENT
or spinal cord injury, while serious, are rare.
THIS
THE THE
2. Effectiveness of Spin
BY
al Cord Stimulation in Chronic Spinal Pain: A Systematic Review
(Grider, 2016)
TGA Assessor summary:
• Summary measures included 50% or more reduction of pain in at least 50% of the patients,
or at least a 3-point decrease in pain scores and a relative risk of adverse events including
side effects.
• Improvement for less than 12 months is considered as short-term and longer than 12
months is considered as long-term.
• Of the 3 randomized trials evaluating SCS, all of them reported effectiveness for short- and
long-term relief
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3. SYSTEMATIC REVIEW OF EFFICACY OF SPINAL CORD STIMULATION FOR MANAGEMENT OF
UNDER CARE
PAIN IN CHRONIC PANCREATITIS (Ratanake)
1982
Background: Spinal cord stimulation (SCS) is frequently used to manage chron
AGED ic pain syndrome in
patients with chronic pancreatitis (CP). This systematic review aim
ACT ed to summarise the indications
AND
and effectiveness of SCS in the management of pain associated w
RELEASED ith CP.
Materials and Methods: A systematic review employing Prisma methodology was performed
BEEN
through interrogation of the PubMed, Medline, EMBASE and Cochr
HEALTH ane databases.
HAS INFORMATION
OF
Results: Seven studies including sixty-six patients met the inclusion criteria. The patient groups
included five case series and two observatio
OF nal cohort studies. The pooled mean age of the study
group was 44 years and 23% (15/66) had alcohol induced CP. The SCS leads were commonly
placed at the level of T5-6 near the anatomic midline of the spine. Patients reported a pooled mean
reduction of visual analogue pain scores
DOCUMENT of 56% and a pooled mean reduction of morphine
DEPARTMENT
equivalent opioid use of 70% at the end o
FREEDOM f follow-up. In contrast to percutaneous leads, surgical
THIS
leads showed a broader stimulation pattern, lower stimulation requirement and was associated with
THE THE
reportedly better longterm effectiveness.
BY
Conclusion: This systematic review has shown that the use of SCS in patients with chronic
pancreatitis may decrease pain, reduce opioid use and improve functional capacity. Further
randomised, controlled trials are required to establish efficacy in the application of SCS for visceral
abdominal pain from CP.
TGA Assessor summary:
• SCS
may reduce pain and opiod use
• Further studies required
4. The Effectiveness of Spinal Cord Stimulation for the Treatment of Axial Low Back Pain: A
Systematic Review with Narrative Synthesis (Conger, 2020)
TGA Assessor summary:
Page 4 of 11
Document 1.1 - FOI 4904
• The reviewed studies were found to be heterogenous across patient populations,
interventions (different SCS technologies), comparators (low-frequency SCS, conventional
medical management, various lead configurations), and outcome measurement tools. For
these reasons, meta-analysis of comparative measures of effect such as a proportion ratio or
proportion difference was not performed.
• This is the first systematic review to examine the effectiveness of different SCS technologies
specifically for long-term reduction of axial LBP in patients with or without concomitant leg
symptoms.
• Review included 2 RCTs (four publications), 4 nonrandomized comparative studies, and 9
single-group cohort studies.
• Several studies did not use back pain as the primary outcome (many measured overall pain
or leg pain) but did report back pain–specific scores.
Secondary outcomes included medication use (opioid and nonopioid), measures of patient
satisfaction, quality of life, and disability.
• Based on low-quality evidence, 10-kHz SCS appears effective beyond six months for axial LBP
reduction in patients with predominantly axial spine pain and in those with mixed axial low
back and leg pain.
• Improvements in pain relief, functional improvement, patient satisfaction, and reduced
opioid use were seen
•
CARE
Considering the consistently large magnitude and durable pain red
UNDER uctions observed in these
studies, further controlled, investigator-initiated studies with long-term follow-up are
1982
needed to investigate the relative effectiveness of 10-kHz SCS on axial L
AGED BP compared with
continued non neuromodulation management and compared with other SCS technologies to
ACT
determine relative effectiveness.
RELEASED AND
• Only one study using burst SCS met inclusion criteria for this review.
o A small, nonrandomized comparative study of 10-kHz SCS and burst modalities
BEEN
showed similar effectiveness between burst and
HEALTH 10-kHz SCS for the treatment of
axial LBP, with similar associated improvement in sleep and physical function,
HAS
OF
however, this study included only 14 patient
INFORMATION s.
o Despite its exclusion
OF
• Previous studies indicate that traditional low frequency SCS is less effective for reducing
axial LBP as compared with neuropathic leg pain.
• The PROCESS trial (2007) compar
DOCUMENT ed traditional low-frequency SCS to CMM and
DEPARTMENT
demonstrated a 48% responder
FREEDOM rate for leg pain reduction at six months but failed to
achieve meaningfu
THIS l axial LBP reduction.
THE
THE
BY
5. Spinal Cord Stimulation vs Conventional Therapies for the Treatment of Chronic Low Back
and Leg Pain: A Systematic Review of Health Care Resource Utilization and Outcomes in
the Last Decade (Odonker 2019)
TGA Assessor summary:
• 11 studies meeting inclusion criteria were analyzed, representing 31,439 SCS patients and
299,182 CT patients
o 6 of 11 studies evaluating SCS vs CT
▪ SCS was associated with favorable outcomes and found to be more cost-
effective than conventional treatment approaches for chronic low back pain
o The most common indication for SCS was failed back surgery syndrome (FBSS),
which was evaluated in 6 of 11 studies.
▪ Other indications included complex regional pain syndrome (CRPS),
peripheral arterial disease (PAD), refractory angina pectoris (RAP), chronic
back and leg pain, chronic axial low back pain, degenerative disc disease,
Page 5 of 11
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radiculitis, neuropathic leg and back pain, and chronic benign pain
syndrome.
• Cost Analysis
o In 6 of 11 studies analysing costs, SCS was associated with favourable outcomes in
terms of cost-effectiveness and health resource utilization compared with
conventional therapy
• Pain Relief
o Overall, 3 of 11 studies included pain relief outcomes
o There was a large discrepancy in reported pain relief outcomes depending on the
type of study and population evaluated
o Some studies suggested that success rate (measured by a >50% improvement in leg
pain) of SCS vs conventional treatment at 24 months was 16% vs 21%, respectively
o Compared with conventional treatment, there was a 2.5-fold reduction in pain
scores at six months, although no differences in reported pain scores, opioid use, or
physical function were found at 24months
o One study showed that 51% of patients achieved >50% improvement in leg pain
intensity.
o Another found that the probability of achieving >50% pain relief was 9.3% for CT and
58.5% for SCS
o Studies among workers’ compensation patients generally showed less
CARE pain relief
UNDER
from SCS compared with conventional treatments.
1982
AGED
• Complications
ACT
o Adverse events associated with SCS were reported in 3
AND of 11 studies
RELEASED
▪ When lumbar surgery was compared with SCS, SCS resulted in a lower
complication rate of 8.6% compared with 16.52% for lumbar surgery
▪
BEEN
Types of complications included renal, cardiac, neurological, pulmonary,
HEALTH
DVT/PE, systemic infection, and pocket site wound infection.
HAS
OF
▪ The authors concluded that overall c
INFORMATION osts between SCS and lumbar surgery
were similar, but SCS was associated with fewer complications and
OF
improved outcomes
o Complications were noted as a major contributor to overall SCS expense
▪ An annual complication rate of 19%/year for SCS þ CT has been reported
DOCUMENT
• Quality Assessment and Level of Evidence R
DEPARTMENT esults of quality assessment and level of
FREEDOM
evidence, using th
THIS e GRADE framework
o
THE
4 of 11 stud
THE ies (36%) had moderate-quality evidence and
o 7 of 11 (64%)
BY had low-quality evidence supporting the primary outcome measures of
higher costeffectiveness, higher percent reduction in opioid use, shorter
hospitalizations, and lower resource utilization with SCS therapy compared with
conventional management
• Risk of Bias Analysis
o There was high publication bias in 7 of 11 studies (64%) and low publication bias in 4
of 11 studies (36%).
o The majority of studies did not report any blinding of participants, personnel or
outcome assessment, and allocation concealment.
o Only one study was an RCT, but almost all studies (10/11) had complete data and, as
far as estimable, little selective reporting bias
6. Spinal cord stimulation for low back pain (Protocol)
STUDY NOT COMPLETED
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Description of the intervention
Spinal cord stimulation (SCS) involves implanting an electrical device in the lower back that
generates electrical pulses and delivers them to the spinal cord via electrodes (Kemler 2000).
Electrodes are positioned in the dorsal epidural space adjacent to the area of the spinal cord thought
to be causing the pain.
The ‘leads’, containing sets of electrodes, can be implanted via laminectomy or percutaneously.
Depending on the location and intensity of the person's pain, a clinician may select from a varying
number and type of leads (uni-, bi-, or multi-polar), and parameters of stimulation (amplitude, pulse
width, electrode selection). The device requires power from a battery pack implanted under the skin
or transcutaneously via a radiofrequency transmitter. Parameters of stimulation can be adjusted
wirelessly using a remote control (Mailis-Gagnon 2013).
Before a surgeon implants the device, current protocols usually require a screening period. Leads are
temporarily placed percutaneously, and the clinician assesses the individual’s response to the
stimulation while they continue with usual activities. The screening phase lasts from days to weeks.
A positive response is often defined as at least 50% pain relief (Kemler 2000). If the screening phase
is positive, a surgeon may offer a laminectomy to permanently implant the stimulator and leads.
Batteries for the stimulator systems can be rechargeable (stimulator type is known as a
'rechargeable implantable pulse generator (IPG)') or conventional (known as a 'conventional IPG').
Conventional IPGs require repeat surgeries to replace the battery.
How the intervention might work
UNDER CARE
The mechanism of action of SCS for low back pain is poorly understood. SCS was originally thought
to work via the gate-control mechanism (Melzack 1965), that is, stimulatio
1982 n of part of the spinal cord
AGED
interrupts transmission of pain-related information to the cortex. However, evidence of the eKects
ACT
of SCS on the relay of pain-related information at the spinal cord in humans is limited (Meyerson
RELEASED AND
2000). In addition, SCS does not appear to influence pain in response to an experimentally induced
noxious stimulus (Meyerson 2000). Other suggested mechanisms have included inhibition of the
sympathetic nervous system (sympatholytic effect) (K
BEEN emler 2000), and interrupted transmission of
HEALTH
pain-related
HAS
OF
nerve impulses by the brain (supraspinal inhibition) (Meyerson 2000). It is unclear whether the
INFORMATION
mechanism of action differs in people with chronic low back pain, compared to those with leg pain,
OF
or those diagnosed with FBSS (Meyerson 2000).
Why it is important to do this review
SCS is thought to be helpful for chronic low back pain, sciatica and FBSS. The National Institute for
DOCUMENT
Health and Care Excellence (NICE) recommends SCS
DEPARTMENT for refractory neuropathic pain (NICE 2020). In
FREEDOM
2014, the SCS market was estimated to be valued at 1.3 billion US dollars (USD) (PRWeb 2015). In
THIS
the USA the average cost of implan
THE ting a stimulator is USD 30,000, plus USD 10,000 per annum for
THE
maintenance care if the perso
BY n experiences complications. One study estimated that 12% of people
who had SCS experienced at least one complication, such as lead migration or wound infection
(Shamji 2015).
Evidence on the benefits and harms of SCS compared with placebo or no treatment, is limited. A
Cochrane Review of efficacy in chronic pain was withdrawn because it was out of date (Mailis-
Gagnon 2013). Grider 2016conducted a systematic review of SCS for low back pain and focused on a
wide range of trials, including those that compared SCS with different stimulation regimens and
various other control treatments of unknown efficacy. This made the true efficacy of the procedure
difficult to determine. Grider 2016 did find three small trials that compared SCS to no treatment or
placebo/sham (160 participants in total). The trials had mixed results. One small trial (n = 40) found
no effect on pain intensity at four weeks compared with placebo SCS (device switched oK)
(Perruchoud 2013). One hallmark 2007 trial by Kumar and colleagues (n =100) investigating SCS as an
addition to 'conventional medical management' found a large effect on leg pain at six months
(-26.7 (95% CI -40.4 to -13.0) points on a 100-point scale) (Kumar 2007). Because the 'conventional
medical management' was not standardised or provided in a controlled way, the comparison was
Page 7 of 11
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essentially between SCS and no treatment.
There have been additional trials since the 2016 review. In 2019, Riogard and colleagues reported on
the PROMISE trial (Rigoard 2019). Similar to the trial by Kumar and colleagues (Kumar 2007),
PROMISE compared SCS plus 'optimal medical management' with 'optimal medical management'
alone. The 'optimal medical management' was not standardised or controlled by the investigators
and so the comparison was, once again, essentially between SCS and no treatment. At six months,
the between-group difference in low back pain was 1.1 (95% CI 0.6 to 1.6) points on a 0 to 10 scale.
The large effect on leg pain previously observed by Kumar and colleagues in 2007 was not
replicated: at six months the effect was 1.3 (95% CI 0.7 to 1.9) points on 0 to 10 scale. The SCS
Frequency Study, a small study (n = 24) that compared SCS treatment at three different frequencies
against 'sham' SCS treatment (device is switched on but not delivering any stimulation), found that
some SCS regimens were not superior to sham (Al-Kaisy 2018). In the Riogard trial, 18% of
participants experienced a stimulator-related adverse event. New trials are also underway (e.g.
MODULATE-LBP (Al-Kaisy 2020)) or have overdue results.
To date, the evidence from trials of SCS suggests that, compared with placebo or no treatment, the
effects on low back pain and leg pain are uncertain. Another Cochrane Review is underway,
examining the effect of SCS on any pain condition (O'Connell 2020). However, those authors have
not planned a subgroup analysis focused specifically on people with low back pain. A focused
Cochrane Review will help resolve some of the uncertainty regarding efficacy of SCS for people with
low back pain, and help clinicians, people with low back pain and policymakers mak
CAREe decisions based
UNDER
on the best available evidence.
1982
AGED
TGA Assessor summary:
ACT
• This study is under way but not complete RELEASED AND
• Study Objectives:
1. To assess the benefits and harms of spinal cord stimulators for people with low back
pain, with or without leg pain.
BEEN HEALTH
• Types of outcome measures: HAS
OF
Major outcome measures
INFORMATION
a) Outcomes assessing benefits: OF
1. Pain intensity: numeric rating scale (NRS), visual analogue scale, pain severity
subscale of brief pain inventory
2. Function: using various scales/scores
DOCUMENT
3. Health-related quality of life: using
DEPARTMENT various scales/scores
FREEDOM
4. Global assessment of efficacy: participant-rated improvement measured as per cent
THIS THE
improvemen
THE t or on categorical scale
b) Outcomes assessing har
BY ms:
1. Proportion of withdrawals due to adverse events
2. Proportion of participants with adverse events: any adverse events reported (e.g.
cardiovascular events, worsening of pain, fatigue, etc.)
3. Proportion of participants with serious adverse events (defined as leading to
hospitalisation, disability or death)
Minor outcomes
a) Medication use: number and proportion of participants taking any pain medication, daily
dose of opioids as a morphine equivalent dose, or as reported in trials
b) Health care use: number of visits to any healthcare provider for care related to
participant's back pain or management of the SCS, or both
c) Work status: number and proportion of participants reported to have returned to work,
work absences,or as reported in trials
Page 8 of 11
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7. A Systematic Review of the Cost-Utility of Spinal Cord Stimulation for Persistent Low Back
Pain in Patients With Failed Back Surgery Syndrome (McClure 2020)
TGA Assessor summary:
SCS Technology and Cost-Effectiveness
• The types of delivery system used and the frequency and tonicity of the stimulation provided
by the device are under heavy development. The use of a more novel paddle design and
configuration has shown superior outcomes compared to traditional electrode size and
placement.
• Other technological improvements include the use of SCS devices that provide stimulation at
much higher frequencies (10 000 vs. 50-100Hz).
• A recent randomized trial demonstrated that not only do patients prefer the higher
frequency SCS devices’ lack of paraesthesia compared to traditional stimulation devices, the
higher frequency devices also provide superior and more durable pain relief.
• A different stimulation method that also seemingly improves upon traditional stimulation
methods provides SCS in a burst pattern rather than tonic stimulation.
• The burst stimulation method is more novel than the high frequency method. As such,
studies assessing its efficacy at time points greater than a year remain unpublished.
• Literature that examined the cost-effectiveness of these more novel devices was not found.
•
CARE
An improvement in SCS cost-effectiveness would result from prolo
UNDER nging the battery life of
non-rechargeable devices. As it currently stands, the published literature that compared the
1982
cost-effectiveness of non-rechargeable and rechargeable devices sho
AGED wed a slight benefit to
rechargeable devices. This is largely due to having fewer replacements over the patient’s
ACT
lifetime and the associated surgical costs. RELEASED AND
• The industry standard device longevity for non-rechargeable devices is *4.5 years. If a non-
rechargeable device does not require replacement until after 4.5 years from initial
BEEN
implantation, it becomes more economical to utilize com
HEALTH pared to the rechargeable models,
given the initial device costs are similar. As such, if the cost of non-rechargeable devices
HAS
OF
could be maintained while simultaneously improving
INFORMATION battery life, this would further improve
cost-effectiveness of SCS devices.
OF
Improving SCS Cost-Effectiveness With Refined Patient Selection
• An alternative method to impro
DOCUMENT ving the cost effectiveness of SCS devices is further refining
DEPARTMENT
patient selection. FREEDOM
• Several studies ha
THIS ve analysed this; however, most of them utilize rather small sample sizes.
THE
Combining the findin
THE gs from these studies, an ideal responder would not use tobacco, be of
BY
normal weight, and be free of psychiatric comorbidities other than anxiety.
• The data surrounding which age group might better respond to SCS for LBP is mixed.
• North et al found that patients who failed SCSdi and crossed over to re-operation failed to
achieve adequate pain relief. This cross-over resulted in inferior outcomes for patients of
lesser pain-relief achieved and lower patient satisfaction, both coming at higher costs as
well; a patient who did not respond to SCS and underwent subsequent re-operation ended
up costing more than double the average patient who just had re-operation and over 5
times the amount of a patient just receiving SCSdi.
8. Systematic Review of Research Methods and Reporting Quality of Randomized Clinical
Trials of Spinal Cord Stimulation for Pain (McNicol 2021)
TGA Assessor summary:
• Review of 46 studies identified deficiencies in both reporting and methodology.
Page 9 of 11
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9. The Role of Spinal Cord Stimulation in Reducing Opioid Use in the Setting of Chronic
Neuropathic Pain (Smith, 2022)
TGA Assessor summary:
• The 17 studies examined in this review illustrate the ability of SCS to aid in the reduction of
opioid use over a wide range of preimplantation doses at 12 months post implantation.
• 6 of the studies included showed 46% to 71.4% of participants were able to reduce their
daily opioid dose from 25% to 64% from their preimplantation dose
• Likewise, 7 from 9 studies showed that participants were able to reduce their daily opioid
dose from 20% to 48.6% from their preimplantation dose, with one study showing only a 7%
dose reduction
• In a systematic review of 5 trials totaling 489 patients, Pollard and colleagues found that SCS
patients were more likely to reduce their opioid consumption than patients using medical
therapy alone.
• In a large, retrospective study of 5476 patients, Sharan et al found that > 91% of patients
kept their implant over all opioid doses at 1 year, with the majority of patients maintaining
or decreasing opioid dosage.
• The success of SCS in supporting the reduction in opioid dose is connected with its ability to
reduce chronic pain.
•
CARE
6 of the 17 studies provided a percentage of patients who were ab
UNDER le to discontinue opioid
use at 12 months post implantation
1982
o These percentages varied from 1.5% to 42.8%.
AGED
o In 2 of these studies, a correlation was made between a particular preimplantation
ACT
opioid dose or dose range and an increased likelihood
AND of discontinuation of opioid
RELEASED
use
• Collectively, these studies suggest that a low preimplantation opioid dose may provide
BEEN
patients with the best chance of eliminating opioid use p
HEALTH ost-SCS implantation.
• Of note, in addition to increasing the possibility of opioid discontinuation, reduction in
HAS INFORMATION
OF
preimplantation opioid dose may also increase the effectiveness of SCS pain reduction.
• Preimplantation opioid use has been
OF consistently shown to reduce the likelihood of pain
remission after SCS.
• The precise reason for this diminution in effectiveness is unknown.
• Studies have shown:
DOCUMENT
DEPARTMENT
o At 1 and 2-year follow-u
FREEDOM p after SCS implantation, system explant was significantly
THIS
associated with opioid use
THE THE
o Others have demonstrated that patients who do not use opioids before SCS
BY
implantation experience superior outcomes as compared with those patients who
used opioids before surgery.
• SCS is an effective treatment for many types of chronic pain, with significant advantages
over medical management alone in both pain relief and side effect profile.
• SCS can also lead to reduction or elimination of chronic opioid use.
• Current research supports the conclusion that SCS should not be reserved as a therapeutic
of last resort, rather it should be considered earlier in the therapeutic process.
• Recent studies have demonstrated that longer pain-to-SCS time has been shown to
correspond to a decreased efficacy of SCS, and increasing pain-to-SCS time is also associated
with significant increases in health care resource utilization.
• Current studies demonstrate that SCS is most effective when used in patients who are not
chronic opioid users before implantation.
Page 10 of 11
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FINAL COMMENTS
• The SCS systems are used in quite complex chronic pain scenarios
• It appears that these systems have undergone design changes and improvements over the
years, with newer version addressing past issues and concerns
• The high complication rates are acknowledged but the causes of these appear to be multi-
factorial in nature e.g Patient selection is crucial; the version of the device used etc
• Non-inferiority studies have shown that new iterations of SCS systems are superior to the
older ones
• Although the cost-effectiveness analyses are based predominantly on overseas data, we
would expect a similar outcome here
• Further data can be requested from manufacturers to determine if there is any areas of
concern for the TGA regarding the numbers and types of complications being encountered in
Australia. A comparison can then be made on whether this is consistent with the
international experience.
o It would be helpful is data could be provided for the following: patient
demographics; therapy type eg burst/high/low frequency therapy; duration of
treatment; numbers of patients who had resolution of symptoms and subsequent
removal of SCS; what patients are told to do routinely following surgery; how
CARE
frequent follow-up reviews are
UNDER
o Depending on the data we receive, I anticipate that we would need to also review
1982
the IFU/PIL and technique guides to ensure that risks are discu
AGED ssed and mitigated
where possible
ACT
RELEASED AND
BEEN HEALTH
HAS INFORMATION
OF
OF
DOCUMENT
FREEDOM
DEPARTMENT
THIS
THE THE
BY
Page 11 of 11
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Spinal Cord Stimulators
Literature Summary
Brief summary:
These devices appear to be a last resort for many cases – the patient populations in the studies usually specified that patients had to be refractory to one or
more medications.
The Cochrane review of Dec 2021 is an excellent synopsis of SCS risk.
They found that SCS is associated with complications including infection, electrode lead failure/migration and a need for reoperation/re‐implantation. The
UNDER CARE
level of certainty regarding the size of those risks is very low. The authors found very low‐certainty evidence that SCS may not provide clinically important
benefits on pain intensity compared to placebo stimulation. At six months follow‐up their estimates
1982 suggest a 4% risk of infection, a 4% risk of lead failure/
AGED
displacement and an 11% risk of requiring reoperation/reimplantation. The authors found reports of some serious adverse events as a result of the
ACT
intervention. These included autonomic neuropathy, prolonged hospitalisation, prolonged monoparesis, pulmonary oedema, wound infection, device
RELEASED AND
extrusion and one death resulting from subdural haematoma.
It appears from initial analysis that the serious complications of neurological adverse events e.g. paralysis, spinal cord hematoma, dural puncture are rare.
BEEN HEALTH
But lead migration is quite common and does require a surgical procedure to correct. Similarly, in the publication of concern by the group of PhD authors,
found that as a proportion of the ‘device failure’ adverse events, lead mig
HAS ration/fractur
OF
e was 35%. Rates of explantation vary from study to study. The
INFORMATION
Cochrane review identified an n=44 study that found 94% of patients had the device explanted at 5 year follow up.
OF
There’s a fair few trials on the SENZA device, which I think is 330704 on the ARTG (see below summary table)
Also for the Evoke model (ARTG 336330) ( see below summary table)
DOCUMENT
FREEDOM
DEPARTMENT
There’s a French registry study including a number of Medtronic models – only 2 years follow up though, funded by Medtronic.
THIS
THE THE
BY
Just looking through the ARTG list of spinal cord stimulators, a lot of devices have been approved recently -2021 and 2020. None have conditions of
inclusion on them (suggesting that PMCFs were not underway at the time of approval). Being Class III or AIMD, these devices would have undergone a
Clinical review in App Audits and any devices with poor evidence or safety concerns would be questioned. It is possible that older devices are contributing
more to the hardware complications reported in the TGA adverse event publication, and whether possibly designs have improved in recent times, however
the signal exists.
Page 1 of 19
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Article/Authors/Year
Study type/ patients/ sample
Results
Conclusions
Level of evidence (NHMRC Hierarchy) +
size/device used
Clinical Assessment
(benefit/risk/uncertainty)
Spinal Cord Stimulators:
Retrospective review of
520 AE’s between 2012-2019
Authors conclude: Spinal cord
Level IV – retrospective review
An Analysis of the
adverse event reports
•
484 (93%) rated as serious using NHMRC criteria
stimulators have the potential for
Adverse Events
submitted to the TGA between
o
73.1% single surgical intervention
serious harm and each year in Australia,
One author has affiliation with Media
Reported to the
2012 and 2019
o
10.3% Other
many are removed. In view of the low
outlet SMH
Australian Therapeutic
o
4% Single surgical intervention + IV
certainty evidence of their long-term
Goods Administration
Parallel collection of
antibiotics
safety and effectiveness, our results
Limitations
implantation and explantation
o
3.1% multiple surgical interventions
raise questions about their role in
•
AE data likely underreported –
Jones et al
numbers of spinal cord
o
2.5% Single surgical intervention and PO
providing long-term man
CARE
agement of
true number likely to be
UNDER
2022
stimulators for the same years,
Abx
intractable pain.
significantly higher than that
using a national health
o
2.3% admitted to hospital for medical
reported to TGA, therefore likely
1982
database
AGED
management
Raises the need for a registry to obtain
a significant signal
CTCAE coding
long-term safety and efficacy data
•
No info on what the indication
ACT
•
1% resulted in death
AND
was for insertion OR removal
RELEASED
•
13% life threatening
•
No stratification of adverse
•
79% severe
events and implantations per
•
3% moderate
device type (multiple SCS on
BEEN
•
HEALTH
3% mild
ARTG…)
•
No information on the timing of
HAS
OF
26,786 implanted and 10,702 removed. 4 in every 10 bein
INFORMATION g
the AE in relation to the event
removed.
•
Inability to actually calculate
OF
adverse event rates for each
Most common events:
device type from this publication
•
Device malfunction n=296/56.5%
•
‘Device malfunction/faulty
o
Failures of de
DOCUMENT vice N=247/47.1%
device’ needs further explanation
o
Migration of the electrical l
DEPARTMENT ead/fracture
FREEDOM
n=87 (35%)
THIS o Faulty device n=42/17%
THE THE
o
Poor positioning n=23/9%
BY
o
Unspecified issue with a lead n=19/8%
•
Pain n=110/21%
•
Infection/inflammatory reaction n=55/10.5%
•
Haemorrhage/hematoma n=7/1.3%
•
Headache n=6/1.1%
•
Puncture/laceration n=5/1%
Page 2 of 19
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Cochrane Review
Systematic review
Active stimulation v placebo
SCS is associated with a reasonably
Level I – systematic review of RCTs
Pain intensity
common incidence of procedure and
December 2021
15 published studies in this
6 studies (N = 164) demonstrated a small effect in favour of SCS
device‐related complications including
The authors found very low‐certainty
review that randomised 908
at short‐term follow‐up. The point estimate falls below our
infection, lead failure or displacement,
evidence that SCS may not provide
Implanted spinal
participants.
predetermined threshold for a clinically important effect (≥10
and the need for further surgical
clinically important benefits on pain
neuromodulation
points). No studies reported the proportion of participants
procedures.
intensity compared to placebo stimulation.
interventions for
All the included evidence in this
experiencing 30% or 50% pain relief for this comparison.
chronic pain in adults.
review relates to spinal cord
For example, at six months follow‐up
SCS is associated with complications
stimulation(SCS).
SCS + other intervention versus other intervention alone
our estimates suggest a 4% risk of
including infection, electrode lead
Pain Intensity
infection, a 4% risk of lead failure/
failure/migration and a need for
Adults ≥ 18 with non‐cancer
Mean difference
displacement and an 11% risk of
reoperation/re‐implantation. The level of
and non‐ischaemic pain of
3 studies (N = 303) demonstrated a potentially clinically
requiring reoperation/reimplantation.
certainty regarding the size of those risks is
longer than three months
important mean difference in favour of SCS of ‐37.41 at short
CARE
very low.
UNDER
duration, due to a variety of
term, and medium‐term follow‐up and no clear evidence for an
causes including nerve disease,
effect of SCS at long‐term follow‐up
Benefits may not outweigh risks to patients
1982
chronic low back pain, chronic
AGED
but based on low-certainty evidence.
neck pain and complex regional
Proportion of participants reporting ≥50% pain relief
ACT
pain syndrome
An effect was found in favour of SCS at short‐term (2 studies, N
Short term follow up in most studies so
RELEASED AND
= 249, RR 15.90, 95% CI 6.70 to 37.74, I2 0% ; risk difference
unknown long term performance (pain
(RD) 0.65 (95% CI 0.57 to 0.74, very low certainty), medium
relief) and potential for increased risk of
term (5 studies, N = 597, RR 7.08, 95 %CI 3.40 to 14.71, I2 =
side effects
BEEN
43%; RD 0.43, 95% CI 0.14 to 0.73, low‐certainty evidence), and
HEALTH
long term (1 study, N = 87, RR 15.15, 95% CI 2.11 to 108.91 ; RD
HAS
OF
0.35, 95% CI 0.2 to 0.49, very low certainty) follow‐up.
INFORMATION
Adverse events
OF
At medium‐term follow‐up, the incidence of lead
failure/displacement (3 studies N = 330) ranged from 0.9 to
14% (RD 0.04, 95% CI ‐0.04 to 0.11, I2 64%, very low certainty).
DOCUMENT
FREEDOM
DEPARTMENT
The incidence of infection (4 studies, N = 548) ranged from 3 to
THIS
7% (RD 0.04, 95%CI 0.01, 0.07, I2 0%, very low certainty).
THE
THE
The incidence of reo
BY peration/reimplantation (4 studies, N =5
48) ranged from 2% to 31% (RD 0.11, 95% CI 0.02 to 0.21, I2
86%, very low certainty).
One study (N = 44) reported a 55% incidence of lead
failure/displacement (RD 0.55, 95% CI 0.35, 0 to 75, very low
certainty), and a 94% incidence of reoperation/reimplantation
Page 3 of 19
Document 1.2 - FOI 4904
(RD 0.94, 95% CI 0.80 to 1.07, very low certainty) at five‐year
follow‐up.
The authors found reports of some serious adverse events as a
result of the intervention. These included autonomic
neuropathy, prolonged hospitalisation, prolonged monoparesis,
pulmonary oedema, wound infection, device extrusion and one
death resulting from subdural haematoma.
A review of spinal cord
Narrative review of spinal cord
Mechanical complications include lead fracture or
Significant evidence exists for traditional
N/A narrative review
stimulation systems for
stimulation systems for chronic
disconnection, which has a reported incidence of between 5%
SCS as a safe, clinical, and cost-effective
chronic pain
pain
and 9%; lead migration has a reported incidence between 0%
treatment for many chronic pain
Conflicts: Paul Verrills is a consultant to
and 27%; implantable pulse generator failure occurred at a
conditions. Indeed, the field is rapidly
NEVRO Corp and St Jude Medical Advisory
(Verrills, 2016)
reported frequency of 1.7%.
evolving, and there
CARE is now Level I
and peer to peer teaching.
UNDER
evidence for newer techniques including
The most common biological complication is infection with
HF10 SCS and DRG SCS, which
Comments:
1982
a rate between 3% and 8%, and the majority of these are
demonstrat
AGED e dramatic improvements
•
Incidence of minor complications
superficial
in overall efficacy in reducing pain in
30-40% (readily reversible and
ACT
specific conditions, including failed back
AND
generally resolved).
RELEASED
The occurrence of dural puncture is reported as between 0.3%
surgery, back pain, neuropathic
•
Hardware related complications
and 2%.
leg pain, CRPS, and causalgia.
24-50%
•
Mechanical complications eg lead
BEEN
Other adverse biological events such as epidural HEALTH
fracture or disconnection 5-9%
fibrosis, compressive phenomenon, or spinal cord injury,
•
Lead migration 0-27%; migration
HAS
OF
while serious, are rare.
INFORMATION
requiring intervention in <5%
OF
These complications are minimised by
using the appropriate lead, anchoring and
suturing techniques; minimising patient
movement in first 3 months to allow
DOCUMENT
scarring to form around leads
FREEDOM
DEPARTMENT
Effectiveness of Spinal
To assess the role and
Results showed 6 RCTs with 3 efficacy trials and 3 stimulation
There is significant (Level I to II)
Level I – systematic review of RCTs
THIS
Cord Stimulation in
effectiveness of spinal cord
trials. There were also 2 cost effectiveness studies available.
evidence of the efficacy of spinal cord
THE THE
Chronic Spinal Pain: A
stimulation (SCS) in chronic
stimulation in lumbar FBSS; whereas,
Conflicts: multiple: Grider – Medtronic and
BY
Systematic Review
spinal pain.
Based on a best evidence synthesis with 3 high quality RCTs, the there is moderate (Level II to III)
Intralink Spinal; Vallego – Cephalon/Teva,
evidence of efficacy for SCS in lumbar FBSS is Level I to II.
evidence for high frequency stimulation;
Nevro; Christo – Medtronic and Boston
(Grider, 2016)
there is limited evidence for adaptive
Scientific
The evidence for high frequency stimulation based on one high
stimulation and burst stimulation.
quality RCT is Level II to III.
There is level 1 evidence for efficacy of SCS
in lumbar FBSS (failed back surgery
syndrome)
Page 4 of 19
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Based on a lack of high quality studies demonstrating the
Limitations: The limitations of this
efficacy of adaptive stimulation or burst stimulation, evidence
systematic review continue to require
Did not consider adverse events
is limited for these 2 modalities.
future studies illustrating
effectiveness and also the superiority of
high frequency stimulation and
potentially burst stimulation.
SYSTEMATIC REVIEW
Only abstract available
7 studies including 66 patients met the inclusion criteria. The
This systematic review has shown that
Level IV – systematic review of
OF EFFICACY OF SPINAL
patient groups included five case series and two observational
the use of SCS in patients with chronic
observational studies
CORD STIMULATION
This systematic review aimed
cohort studies. The pooled mean age of the study group was 44
pancreatitis may decrease pain, reduce
FOR MANAGEMENT OF
to summarise the indications
years and 23% (15/66) had alcohol induced CP.
opioid use and improve functional
TGA Assessor summary:
PAIN IN CHRONIC
and effectiveness of SCS in the
capacity. Further randomised,
SCS may reduce pain and opiod use
PANCREATITIS
management of pain associated
The SCS leads were commonly placed at the level of T5-6 near
controlled trials are required to
Further studies required
with chronic pancreatitis.
the anatomic midline of the spine.
establish efficacy in
CARE the application of
UNDER
(Ratanake)
SCS for visceral abdominal pain from CP.
No information on adverse events/safety
Patients reported a pooled mean reduction of visual analogue
Low quality evidence
1982
pain scores of 56% and a pooled mean reduction of morphine
AGED
Small numbers of patients, compatible
equivalent opioid use of 70% at the end of follow-up.
with the atypical indication (chronic
ACT
pancreatitis)
RELEASED AND
In contrast to percutaneous leads, surgical leads showed a
broader stimulation pattern, lower stimulation requirement
and was associated with reportedly better longterm
BEEN
effectiveness.
HEALTH
The Effectiveness of
Systematic review.
Randomized or nonrandomized comparative studies and
According to GRADE, there is low-
Level I – systematic review including RCTs
HAS
OF
Spinal Cord Stimulation
nonrandomized studies without internal controls were
quality evidence that high-frequency
INFORMATION
for the Treatment of
Patients: aged 18 with axial LBP
included.
SCS compared with low-frequency SCS is
TGA Assessor summary:
OF
Axial Low Back Pain: A
with or without accompanying
effective in patients with axial LBP with
•
Only low quality evidence of
Systematic Review with
leg pain.
17 publications included. For high-frequency SCS, the only level
concomitant leg pain.
effectiveness of high frequency
Narrative Synthesis
1 study showed that 79% (95% confidence interval ¼ 70–87%)
vs low frequency SCS for LBP with
Intervention: Traditional low-
of patients reported 50% pain improvement.
There is very low-quality evidence for
leg pain
DOCUMENT
(Conger, 2020)
frequency, burst, or high-
low-frequency SCS for the treatment of
•
Only low quality evidence for low
FREEDOM
DEPARTMENT
frequency SCS. Comparison.
For low-frequency SCS, the only level 1 study reported no
axial LBP in patients with concomitant
frequency SCS for back pain with
THIS
Sham, active standard of care
categorical data for axial LBP-specific outcomes; axial LBP
leg pain.
leg pain
THE THE
treatment, or none.
improved by a mean 14mm on the visual analog scale at six
•
No information on adverse
months.
BY
There is insufficient evidence addressing
events/safety
Outcomes: The primary
the effectiveness of burst SCS to apply a
outcome was 50% pain
GRADE rating.
No funding sources
improvement, and the
secondary outcome was
Conflicts of interest: Zachary L. McCormick,
functional improvement
MD, serves on the Board of Directors of the
Page 5 of 19
Document 1.2 - FOI 4904
measured six or more months
Spine Intervention Society. Mark A. Mahan,
after treatment intervention.
MD, is a consultant for Joimax and Axogen.
Spinal Cord Stimulation
The purpose of this review is to
11 studies met inclusion criteria, representing 31,439 SCS
For the treatment of chronic low back
Level I – systematic review of RCTs, and
vs Conventional
critically appraise the literature
patients and 299,182 CT patients.
and leg pain, the majority of studies are
other studies
Therapies for the
for evidence supporting the
of fair quality, with level 3 or 4 evidence
Treatment of Chronic
health care resource utilization
In 8/11 studies, SCS was associated with favorable outcomes
in support of SCS as potentially more
TGA Assessor summary:
Low Back and Leg Pain:
and cost-effectiveness of spinal
and found to be more cost-effective than CT for chronic low
cost-effective than CT, with less
•
Mainly Level 3 or 4 evidence
A Systematic Review of
cord stimulation (SCS)
back pain.
resource expenditure but higher
showing evidence which supports
Health Care Resource
compared with conventional
complication rates. SCS therapy may yet
cost-effectiveness of SCS in
Utilization and
therapies (CTs) for chronic low
Compared with CT, SCS resulted in shorter hospital stays and
play a role in mitigating the financial
chronic lower back pain and leg
Outcomes in the Last
back and leg pain.
lower complication rates and health care costs at 90 days.
burden associated with chronic low
pain
Decade
back and leg pain.
•
Higher complication rates with
SCS was associated with significant improvement in health-
CARE
SCS noted
UNDER
(Odonker 2019)
related quality of life, health status, and quality-adjusted life-
•
No conflicts, no funding sources
years.
to declare
1982
AGED
Adverse events associated with SCS were reported in 3/11 ACT
studies
RELEASED AND
When lumbar surgery (N=16,060) was compared with SCS
(N=395), SCS resulted in a lower complication rate of 8.6%
BEEN
compared with 16.52% for lumbar surgery
HEALTH
HAS
OF
Another study looking at 196 SCS cases reported hardware
INFORMATION
malfunction in 45 patients, infection in 10 patients, and
OF
subcutaneous hematoma in eight patients
An annual complication rate of 19%/year for SCS + CT has been
reported and corroborates prior reports citing an 18%/year
DOCUMENT
complication rate after SCS implantation
FREEDOM
DEPARTMENT
A Systematic Review of
A systematic review was
The majority of reviewed publications that analyzed cost-
The data suggest that SCSdi provides
Level IV – systematic review of
THIS
the Cost-Utility of
conducted inclusive of all
effectiveness of SCSdi compared to conventional medical
both superior outcomes and a lower
observational studies
THE THE
Spinal Cord Stimulation
publications in the Medline
management (CMM) or re-operation in patients with failed
incremental cost: effectiveness ratio
for Persistent Low Back
database and Cochrane
back surgery syndro
BY me (FBSS) showed an overall increase in
(ICER) compared to CMM and/or re-
Comments: significant funding received by
Pain in Patients With
CENTRAL trials register within
direct medical costs; these increased costs were found in nearly
operation in patients with FBSS. These
one author in personal fees from various
Failed Back Surgery
the last 10 years (English
all cases to be offset by significant improvements in patient
findings are in spite of the fact that the
medical device companies
Syndrome
language only) assessing the
quality of life.
majority of studies reviewed were
cost-effectiveness of Spinal
agnostic to the type of device or
Only provides cost effectiveness
(McClure 2020)
Cord Stimulator device
innervation utilized in SCSdi. Newer
information, nothing on adverse events or
implantation (SCSdi) in patients
devices utilizing burst or higher
performance
Page 6 of 19
Document 1.2 - FOI 4904
with previous lumbar fusion
The cost required to achieve these increases in quality adjusted
frequency stimulation have
surgery.
life years (QALY) falls well below $25 000/QALY, a conservative
demonstrated their superiority over
The data suggest that SCSdi provides both
estimate of willingness to pay.
traditional SCSdi via randomized clinical
superior outcomes and a lower
trials and may provide lower ICERs.
incremental cost: effectiveness ratio
compared to conventional medical
management or re-operation in patients
with failed back surgery syndrome
Systematic Review of
Relevant articles were
11 studies stated that they blinded participants. Of these, only
Useful reporting recommendations for
Level I – systematic review of RCTs
Research Methods and
identified by searching the
5 were assessed as being adequately blinded.
RCTs of SCS for pain
Reporting Quality of
following databases through
Randomized Clinical
December 31, 2018: MEDLINE,
The number of participants enrolled was generally low (median
For example:
TGA Assessor summary:
Trials of Spinal Cord
Embase, WikiStim, The
38) and study durations were short (median 12 weeks),
These should include:
Review of 46 studies identified deficiencies
Stimulation for Pain
Cochrane Database of
particularly in studies of angina.
•
Study me
CARE thodology:
in both reporting and methodology.
UNDER
Systematic Reviews, and The
•
Clinical eligibility criteria
Significant conflicts of interest and funding
(McNicol 2021)
Cochrane Central Register of
15 studies employed an intention-to-treat analysis, of which
•
Duration of washout in cross-
sources declared
1982
Controlled Trials.
only seven specified a method to accommodate missing data.
AGED over trials
•
Extent and methodology of
Nothing specific for SCS but it does include
ACT
46 studies were included.
Review of these studies identified deficiencies in both reporting
AND
blinding
a very useful table for criteria to assess in
RELEASED
87% of articles identified a pain
and methodology. The review’s findings suggest areas for
•
Methods of randomization
reading RCTs of SCS for pain. (page 12/16)
related primary outcome.
improving the design of future studies and increasing
and its concealment
transparency of reporting.
•
Role of screening phase in
BEEN
Secondary outcomes included
HEALTH
enrollment of participants
physical functioning, health-
•
Initial settings and adjustment
HAS
OF
related quality of life, and
INFORMATION
parameters for SCS units
reductions in opioid use.
•
Allowance of concurrent
OF
treatments
19 of the 46 studies
•
Methods to ensure balanced
prespecified adverse events as
expectation of benefit of both
an outcome, with 4 assessing
DOCUMENT
researchers and patients
them as a primary outcome.
DEPARTMENT
(equipoise) between groups,
FREEDOM
and also balance of
THIS THE
nonintervention treatment
THE
between groups (eg,
BY
programming time,
psychological support,
physical activity, rescue meds,
etc.)
Treatment-Limiting
The study aims to evaluate the
345 patients were considered candidates for dorsal column
SCS is an effective treatment for chronic
Level IV
Complications of
long-term implant survival and
stimulation and underwent a trial.
noncancer pain. It is a minimally
Percutaneous Spinal
complications of spinal cord
TGA Assessor summary:
Page 7 of 19
Document 1.2 - FOI 4904
Cord Stimulator
stimulation (SCS) leading to
234 patients were implanted with an implant-to-trial ratio of
invasive procedure, safe, and with good
SCS is an effective treatment for chronic
Implants: A Review of
surgical revision or explant in
67–86% across various chronic pain entities (postlaminectomy
long-term outcomes.
noncancer pain.
Eight Years of
patients treated for chronic
syndrome, complex regional pain syndrome, small-fiber
It has good long-term outcomes.
Experience From an
noncancer pain.
peripheral neuropathy, abdominal/pelvic pain, nonsurgical
However, the surgical revision and
The surgical revision and explant rates are
Academic Center
candidates with lumbosacral neuropathy, and neuropathic pain
explant rates are relatively high.
relatively high.
Database
Retrospective study of all
not otherwise specified), with the exception of nonsurgical
patients who underwent a
candidates with lumbosacral neuropathy who had an implant
As the use of SCS continues to grow,
Dr. Salim Hayek is a paid consultant for
(Hayek, 2015)
percutaneous SCS trial followed
ratio of 43%.
research into the causes of and risk
Boston Scientific and owns stock option
by implant in an academic pain
factors for SCS-related complications is
with Neuros Medical
medicine division by 4
The complication rate was 34.6%, with the hardware related
paramount to decrease complication
practitioners from 2007-2013
being the most common reason, comprising 74.1% of all
rates in the future.
with follow up data through
complications.
2014
UNDER CARE
The revision and explant rates were 23.9% each. The most
common reason for explant was loss of therapeutic effect
1982
(41.1%).
AGED
The Role of Spinal Cord
Systematic review of literature
Systematic review of the literature yielded 17 studies providing
SCS is an effective treatment for many
Level III-IV – systematic review of
ACT
Stimulation in Reducing
from PubMed, Web of Science,
data on pre-SCS and post-SCS implantation dose and 4
types of chronic pain and can reduce or
observational studies
RELEASED AND
Opioid Use in the
and Ovid Medline search of
providing data on the preimplantation opioid dose that
eliminate chronic opioid use.
Setting of Chronic
“opioid” and “pain” and “spinal
significantly increased likelihood of opioid use discontinuation
Preimplantation opioid dose may
TGA Assessor summary:
Neuropathic Pain
cord stimulator.” Inclusion
at 12 months postimplantation.
impact discontinuation of opioid use
SCS is an effective treatment for many
BEEN
criteria included original
HEALTH postimplantation and the effectiveness types of chronic pain and can reduce or
(Smith, 2022)
research providing data on SCS
Data from included studies indicated that SCS is an effective
of SCS in the relief of chronic pain. More
eliminate chronic opioid use.
HAS
OF
preimplantation opioid dosing
tool in reducing opioid dose from preimplantation levels at 12
research is needed
INFORMATION
and 12 months
months postimplantation.
to support and strengthen clinical
No information on adverse events
OF
postimplantation opioid dosing
recommendations for initiation of SCS
or that correlated specific
Data preliminarily supports the assertion that initiation of SCS
use at lower daily opioid dose.
preimplantation opioid dose or
at a preimplantation opioid dose of ≤ 20 to ≤ 42.5 morphine
opioid dose cutoff with
milligram equivalents increases the likelihood of
DOCUMENT
significantly increased
postimplantation elimination of opioid use.
FREEDOM
DEPARTMENT
likelihood of opioid use
THIS
discontinuation at 12 months
THE
postimplantation.
THE
Efficacy and Safety of
In total, 16 articles were
Mean pain relief was
BY >50% in most studies, regardless of
Complication incidence rates were
Level IV - Systematic review of
10 kHz Spinal Cord
eligible for inclusion; 15
follow-up duration. Responder rates ranged from 67–100% at
consistent with other published SCS
retrospective case series
Stimulation for the
reported effectiveness
≤12 months follow-up, and from 46–76% thereafter. 32–71% of
literature. Findings suggest 10 kHz SCS
Treatment of Chronic
outcomes and 11 presented
patients decreased opioid or nonopioid analgesia intake.
provides safe and durable pain relief in
Only reviewed PubMed
Pain: A Systematic
safety outcomes.
pragmatic populations of chronic pain
Low bar for included studies “if the clinical
Review and Narrative
Safety:
patients. Furthermore, it may decrease
outcome or safety data were collected
opioid requirements, highlighting the
retrospectively from at least three human
Page 8 of 19
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Synthesis of Real-World
Patients: heterogenous group.
•
Lead migration: 0-7.1% for leads in thoracic region
key role 10 kHz SCS can play in the
subjects implanted with a Senza® 10 kHz
Retrospective Studies
various conditions
and 4.3-18.2% for leads in cervical area
medium-term management of chronic
SCS system. The minimum follow-up period
•
Infection: 0-13%
pain.
was 3 months.”
2021
Device: Senza® 10 kHz SCS
•
Pain over site of implantable pulse generator: 0-
system (Nevro Corp., Redwood
27.3%
Low quality evidence for safety and
City, CA, USA)
•
Insufficient pain relief/nonresponders/treatment
effectiveness
failure: 0-15.8%
•
Lead fracture: 0-2.6%
•
Neurological injury: neuro deficit not reported by any
study.
•
System explantation: 3.7 – 5%
Effect of High-
N=216 prospective,
The prespecified primary end point was percentage of
Patients with painful diabetic
Level II - RCT
CARE
frequency (10-kHz)
multicentre, open-label,
participants with 50% pain relief or more on VAS without
neuropathy with inadequate pain relief
UNDER
Spinal Cord Stimulation
randomised controlled trial
worsening of baseline neurological deficits at 3 months.
despite best available medical
Short follow-up – 6 months only
in Patients With Painful
comparing 10kHz spinal cord
treatme
1982 nts should be considered for 10-
AGED
Diabetic Neuropathy
stimulation with the SENZA-
The primary end point assessed in the intention-to-treat
kHz spinal cord stimulation.
PDN to medical management in
population was met by 5 of 94 patients in the CMM group (5%)
ACT AND
2021
painful diabetic neuropathy
and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%;
Substantial pain relief and improved
RELEASED
difference, 73.6%; 95% CI, 64.2-83.0; P < .001).
health-related quality of life sustained
Patients with PDN for >1 year
over 6 months demonstrates 10-kHz SCS
refractory to gapapentinoids
There were no study-related AEs reported for the CMM group
can safely and effectively treat patients
BEEN HEALTH
and at least 1 other analgesic
18 AEs reported among 14 patients in the 10-kHz SCS plus CMM
with refractory PDN.
class
group:
HAS
OF
•
3 study-related AEs for infection, 2 for wound
INFORMATION
SENZA-PDN
dehiscence, and 1 for impaired healing among 5 of 90
OF
patients (6%).
6-month follow up and optional
•
Of 90 total implanted patients, 2 (2%) required
crossover at 6 months
explant.
•
There were no stimulati
DOCUMENT on-related neurological
deficits in the 10-kHz SCS plus CMM g
DEPARTMENT roup.
FREEDOM
Complications of Spinal
A review of the major recent
The incidence of complications reported varies from 30% to
Spinal cord and peripheral
N/A – narrative review
THIS
Cord Stimulation and
publications in the literature on
40% of patients affected b
THE y one or more complications.
neurostimulation techniques are safe
THE
Peripheral Nerve
the subjects of spinal cord,
and reversible therapies. Hardware-
This publication was cited in the 2022 TGA
BY
Stimulation Techniques:
occipital, sacral and peripheral
Incidence of complications varied depending on the study:
related complications are more
adverse events data analysis
A Review of the
nerve field stimulation
commonly observed than biological
Literature
Lead migration: mean 15.49%, range 2.1-27%
complications. Serious adverse events
No conflicts, no funding sources
Multiple databases searched
Lead fracture and malfunction: mean 6.37%, range 0-10.2%
such as neurological damage are rare.
2016
but no information on the
Implant-related pain: mean 6.15%, range 0.9-12%
number of studies included
Infection: mean 4.89%, range 2.5-10%
The rate of development of
Battery failure: range 1.7-10.2%
complications is governed by factors
Page 9 of 19
Document 1.2 - FOI 4904
Device removal: 0-47%
such as the lead position in the spine or
Dural puncture: 0-0.3%
periphery, the experience of the
Neurological injury: major neurological deficit 0.25%, 0.14%
surgeon and the availability of custom-
limited motor deficit, 0.013% autonomic changes, 0.1% sensory
made equipment for the technique.
deficit in a sample of 44,587 cases
Factors affecting the rate of occurrence of complications:
•
Location of the lead
•
Epidural vs extra-spinal position of the lead
•
Relative novelty of a technique and operating
surgeon’s experience
•
Hardware appropriateness for the procedure
•
CARE
Reporting of complications
UNDER
Novel 10-kHz High-
N=198 subjects with both back
Responders (the primary outcome) were defined as having 50%
The study is the first pivotal study in the
Level II – RCT
frequency Therapy
and leg pain
or greater back pain reduction with no stimulation-related
history o
1982 f SCS to provide comparative
AGED
(HF10 Therapy) Is
neurological deficit.
safety and effectiveness data between
Benefit for high frequency SCS over
Superior to Traditional
Multicenter, randomized,
two SCS systems, providing long-term
conventional SCS
ACT
Low-frequency Spinal
controlled, pivotal trial
At 3 months, 84.5% of implanted HF10 therapy subjects were
ou
AND tcomes for both back and leg pain.
RELEASED
Cord Stimulation for the
responders for back pain and 83.1% for leg pain, and 43.8% of
Limitations:
Treatment of Chronic
Comparing high frequency (HF)
traditional SCS subjects were responders for back pain and
Multiple conflicts of interest declared by
Back and Leg Pain: The
SCS to conventional SCS
55.5% for leg pain (P < 0.001 for both back and leg pain
authors
BEEN
SENZA-RCT Randomized
comparisons).
HEALTH
Confounding effect of analgesics allowed
Controlled Trial
An investigational HF10
during the trial
HAS
OF
therapy system (Senza®
The relative ratio for responders was 1.9 (95% CI, 1.4 to 2.5)
INFORMATION for
Investigators and subjects were not
2015
System; Nevro Corp., USA)
back pain and 1.5 (95% CI, 1.2 to 1.9) for leg pain. The
masked to the assigned treatment group
OF
superiority of HF10 therapy over traditional SCS for leg and
Short follow-up 12 months
back pain was sustained through 12 months (P < 0.001). HF10
therapy subjects did not experience paresthesias.
DOCUMENT
No stimulation-related neurological deficits in either treatment
FREEDOM
DEPARTMENT
group. THIS
THE THE
The most common study-related AEs were implant site pain (in
BY
11.9% of HF10 therapy subjects and 10.3% of traditional SCS
subjects) and uncomfortable paresthesia (in 0.0% of HF10
therapy subjects and 11.3% of traditional SCS subjects).
Lead migration resulting in surgical revision occurred in 3.0% of
HF10 therapy subjects and 5.2% of traditional SCS subjects
Page 10 of 19
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Pain Relief and Safety
Systematic literature search
Primary outcome measures: magnitude of change in pain from
Findings suggest 10 kHz SCS is a
Level III – systematic review of
Outcomes with Cervical
including studies reporting
baseline to follow-up, the proportion of subjects achieving a
promising, safe, minimally invasive
observational studies
10 kHz Spinal Cord
outcomes for cervical 10 kHz
50% reduction in pain, and adverse events related to the device
alternative for managing chronic upper
Stimulation: Systematic
SCS
or procedure.
limb and neck pain.
Limitations
Literature Review and
-
Funded by Nevro Corp
Meta-analysis
15 studies included: 8
Performance:
-
Limited by low quality of
retrospective observational
The proportion of patients who achieved ≥ 50% pain reduction
included evidence – no RCTs
2021
studies, 4 prospective single-
was 83% (95% CI 77–89%) in both the FE and RE models.
-
Heterogenous patient indications
arm studies, 2 case reports, and
1 post-hoc sub-analysis that
The proportion of patients who reduced/eliminated their
combined the data from two of
opioid consumption was 39% (95% CI 31–46%) in the FE model
the prospective observational
and 39% (95% CI 31–48%) in the RE model.
studies
UNDER CARE
Safety:
Patient population: upper limb
Pain or discomfort with the implant: 2-27% of patients
1982
and/or neck pain, neuropathic
Lead migration: incidence 0-14%
AGED
limb pain, headache/migraine,
Surgical revision rates: 0-29%
ACT
CRPS.
Explantation: 0-13%
RELEASED AND
Neurological/paraesthesia: 0% of patients in included studies
Senza® SCS system
Timing and prevalence
N=100 retrospective chart
Out of 100 patients who had SCS implants, we found that 34%
Our findings demonstrate that most SCS
Level IV
BEEN
of revision and removal
review of chronic pain patients
of patients underwent revision surgery and 53% of patients ha
HEALTH d systems are removed within a few years
surgeries after spinal
presenting with SCS related
their implant removed.
post implantation, highlighting
Conflicts: WSA is a consultant for Globus
HAS
OF
cord stimulator
encounters
the clinical need for a more complete
Medical and is on the Advisory Board of
INFORMATION
implantation
Of the patients who required revision surgeries, the majority
understanding of SCS technology in
Longeviti, LLC
OF
Johns Hopkins hospital
(56%) eventually opted for removal of their SCS system.
order to refine patient selection criteria.
Funding: PQD was supported by NIH
Negoita, 2018
2011-2018
The median time to the first revision surgery was 16 months
Medical Scientist Training Program
post implantation and the median time to removal was 39
Training Grant T32GM007205
DOCUMENT
months post implantation.
FREEDOM
DEPARTMENT
Post-implantation surgeries can either be
THIS
revisions due to device-related
THE THE
complications, which are quite frequent for
BY
SCS or complete removal of the SCS system
Progressive Paraplegia
Case report n=1
61-yr-old man presented with progressive
SCS implantation is generally a safe
N/A case report
from Spinal
bilateral lower extremity weakness resulting in complete
procedure, but rare severe late
Cord Stimulator Lead
Discusses the first
paraplegia, T4YT10 bilateral radicular pain, and bladder and
neurologic complications occur,
Fibrotic
reported case of SCS electrode
bowel incontinence for 12 mos
in this case 10 yrs after SCS
Encapsulation
fibrotic encapsulation
implantation, and are reported.
Page 11 of 19
Document 1.2 - FOI 4904
in the thoracic spine occurring
The computed tomographic myelogram indicated increased
Benfield, 2016
10 yrs after SCS
dorsal epidural soft tissue around SCS leads at approximately
Patients with SCS presenting with loss of
placement causing progressive
T7Y9 spinal cord level, consistent with focal fibrosis and
pain relief and/or worsening
paraplegia, thoracic
granulation tissue with an interval increase in spinal canal
neuromuscular examination
radiculopathy, and neurogenic
stenosis.
need to be urgently evaluated for late
bladder and bowel in
complications regarding SCS
the United States.
Neurosurgery performed posterior decompressive
implantation causing cord
T7Y9 laminectomies with removal of SCS electrodes
compression and spinal stenosis at the
and battery.
level of the SCS electrode.
The 3.6 x 3 x 1.1 cm piece of tissue encapsulating the SCS
electrodes was soft tissue with acute and chronic inflammation
with unremarkable bone and cartilage
UNDER CARE
He is now a home ambulator with a walker
1982
but still requires occasional assistance with transfers
AGED
and use of a manual or power wheelchair in the
ACT
community and occasionally within his home. There
RELEASED AND
was resolution of his bowel incontinence but no
change in his neurogenic bladder, which required a
Foley catheter.
BEEN
Infection Rate of Spinal
Retrospective chart review of
During the trial one infection (1.2%) occurred with removal of
HEALTH Our infection rate (4.8%) compared
Level IV
Cord Stimulators After a
84 patients with SCS
the SCS leads.
favorably with our previous survey
HAS
OF
Screening Trial Period.
implantations between 2004 to
(7.5%).
No funding or conflicts
INFORMATION
A 53-Month Third Party
2008 with a trial period lasting
Three infections (3.6%) occurred after the
OF
Follow-up
1-3 weeks
second stage and were successfully treated with antibiotics.
The reduced number of SCS infections is
Statistics from article:
likely to be due to: strict asepsis, double
Serious complications associated with SCS
Rudiger, 2010
United Kingdom
No full implant was explanted due to infection.
layer hydrocolloid dressing during the
implants, e.g., epidural hematoma (0–
trial, prophylactic antibiotics, operator
0.3%), cerebrospinal fluid leak (0.3–0.5%),
DOCUMENT
The more skilled/experienced operator had a lower infection
experience, and patient education.
permanent neurological harm (paralysis =
FREEDOM
DEPARTMENT
rate (1.8%) than the less skilled/experienced (13%).
0.03%) and death, are rare
THIS
Two-stage procedures with extended
THE
THE
trials do not seem to increase the
More commonly lead migration
BY
incidence of SCS infections.
(7–21.5%) or damage (6–9%), malfunction
of the equipment or failure (4.5–10%), and
insufficient pain relief during a trial period
(17–25%) occur (3,7–10). The rate of
infections associated with the
implantation of an SCS is quoted as 2.5–
12%
Page 12 of 19
Document 1.2 - FOI 4904
SCS device-related infections could lead to
neurological harm due to epidural
abscesses or meningitis (<1%).
Epidural Hematomas
2 case reports of spinal
Two patients developed spinal epidural hematomas
American Society of Regional
N/A case reports
After Removal of
epidural hematoma formation
shortly after removal of their percutaneous trial leads and
Anesthesia and Pain Medicine
Percutaneous
required multilevel laminectomies for evacuation of the
guidelines state that nonsteroidal anti-
Authors recommend discontinuing NSAIDs,
Spinal Cord Stimulator
Patient 1: chronic pain of right
hematoma.
inflammatory drugs do not significantly
particularly aspirin, prior to SCS
Trial Leads
lower extremity
increase the risk for epidural hematoma
implantation
Patient 1 reported taking aspirin the morning that his leads
with neuraxial anesthesia and,
Giberson, 2014
Patient 2: chronic severe low
were pulled, whereas patient 2 had not taken aspirin in the 7
therefore, there is no need to
Statistics from article:
back pain
days before commencing his trial.
discontinue these drugs before epidural
The actual incidence of hematomas is
or spinal anesthesia.
CARE
unknown, but it is believed to be a rare
UNDER
There were 2 days between identification and evacuation of
complication, occurring in approximately
patient 1’s hematoma, and he did not fully recover from the
We suggest that these guidelines may
0.2% to 0.3% of cases.
1982
injury to his spinal cord.
not be appro
AGED priate for
neuromodulatory techniques that likely
5 case reports of epidural hematomas
ACT
Patient 2 underwent surgery immediately with complete
subject the surrounding vasculature to
associated with SCS have been published
RELEASED AND
resolution of his symptoms
more trauma than neuraxial anesthesia.
Successful removal of
10-year retrospective study
Five (12.5%, M/F = 4/1) of 40 patients (M/F = 33/7) successfully
Even though this study had limited data,
Level IV – retrospective chart review
permanent spinal cord
was performed on patients
removed the permanent implant.
younger patients with CRPS type 1 could
BEEN
stimulators in
who had received the
HEALTH remove their SCSs within a 5-year
Comments:
patients with complex
permanent implantation of an
The mean age was younger in the removal group (27.2 ± 6.4 vs.
period and return to work with
HAS
OF
regional pain syndrome
SCS and had removed it 6
43.5 ± 10.7 years, P ＜ 0.01).
complete pain relief
No conflicts/funding
INFORMATION
after complete
months after discontinuation of
OF
relief of pain
stimulation, while halting all
The mean duration of implantation in the removal group was
A minority of patients with CRPS have had
medications for neuropathic
34.4 ± 18.2 months.
the SCS removed, with complete resolution
pain.
of pain and been able to return to work
Lee, 2019
Two of 15 patients (13.3%) and 3 of 25 patients (12%) who had
DOCUMENT
Age, sex, duration of
upper and lower extremity pain, respectively, had removed the
FREEDOM
DEPARTMENT
implantation, site and type of
implant.
THIS
CRPS, and their return
THE THE
to work were compared
The implants could be removed in 5 of 27 patients (18.5%) with
between the removal and non-
CRPS type 1. BY
removal groups.
All 5 patients (100%) who removed their SCS returned to work,
while only 5 of 35 (14.3%) in the non-removal group did.
Improving care of
We reviewed literature
Evidence found for the ability of an SCS to reduce opioid usage
Both conventional and 10 kHz SCS are
N/A – literature review, narrative review
chronic pain patients
evidence in PubMed on pain
associated with improving clinical
with spinal cord
relief and opioid reduction
outcomes while also reducing
Page 13 of 19
Document 1.2 - FOI 4904
stimulator therapy
following spinal cord
Multiple studies, including RCTs, prospective non randomised
opioid use and that 10 kHz SCS may be
Advantage of 10kHz SCS is that no
amidst the opioid
stimulation (SCS)
and retrospective, cited that demonstrate patient reduction in
comparatively safer with no
paraesthesia is triggered
epidemic
treatment.
opioid usage, across a variety of conditions (back, leg, upper
uncomfortable paresthesia.
limb and neck pain)
Conflicts: Gupta – funds and serving on
Gupta, 2020
scientific advisory boards
Statistics from article:
Conventional, low frequency
SCS, typically delivered at frequencies
ranging from 40 to 60 Hz, has been shown
CARE
to provide effective pain relief in
UNDER
approximately 50% of patients in RCTs
1982
AGED
High-frequency SCS delivered
at 10 kHz has demonstrated superiority in
ACT
magnitude of pain relief and number of
RELEASED AND
responders as compared with low-
frequency SCS in an RCT
BEEN
Awake vs. Asleep
A retrospective review was
The incidence of device failure for patients implanted using
HEALTH Non-awake surgery is associated with Level IV
Placement of Spinal
performed of 387 SCS surgeries
neurophysiologically guided placement under general
fewer failure rates and therefore fewer
HAS
OF
Cord Stimulators: A
among 259 patients which
anesthesia was one-half that for patients implanted awake
re-operations, making it a viable
No conflicts
INFORMATION
Cohort Analysis of
included 167 new stimulator
(14.94% vs. 29.7%).
alternative.
OF
Complications
implantation to determine
Associated With
whether first time awake
The incidence of device failure for patients implanted under
Any benefits of awake implantation
Placement
surgery for placement of spinal
general anesthesia was one half that for patients implanted
should carefully be considered in the
cord stimulators is preferable
awake (14.94% vs. 29.7%, p < 0.03).
future
DOCUMENT
Falowski, 2010
to non-awake placement.
FREEDOM
DEPARTMENT
The rate of infection was analyzed. There was not a statistically
THIS
significant differencewhen comparing awake (4.48%) to non-
THE
awake (5.7%) plac
THE ement for rate of infection and therefore the
occurrence of infecti
BY on is not explained by whether wake-up
was used at the first surgery
Association Between
Retrospective review of 88
Of the total cohort, 79% had successful permanent SCS
Low pain scores after SCS trial are
Level IV
Pain Scores and
patients with SCS trials
implantation.
predictive of successful SCS implants
Successful Spinal Cord
with high sensitivity.
Stimulator Implantation
Examined association between
post-SCS pain scores and
No funding
Page 14 of 19
Document 1.2 - FOI 4904
Orhurhu, 2019
successful permanent SCS
Post-SCS trial pain scores less than or equal to 4.9 had greater
Males and surgical patients with higher
implants
than 50% probability of a successful permanent SCS implant
pain scores had a lower probability of
(97.14% sensitivity, 44.44% specificity, ROC = 0.71).
successful SCS implant than their
counterparts. Larger studies are needed
Post-SCS trial pain scores between 4 and 7 were associated
to further elucidate this relationship
with a significantly higher probability of a successful SCS
implant among patients without spine surgery compared with
those with a history of spine surgery.
Compared with males, females with pain scores between 5 and
7 had a higher probability of a successful SCS implant.
High-Frequency Spinal
Retrospective case series n=13
Thirteen patients were trialed, 12 of whom went on to receive
This small case series suggests that
Level IV
Cord Stimulation at
a permanent implant. Of the patients receiving permanent
HF10-SCS may be a v
CARE iable option for
UNDER
10 kHz for the
Patients with Complex Regional
implants, the responder rate (50% pain relief) was 67% (95%
patients with CRPS who have chronic
Suggestion of benefit for patients with
Treatment of Complex
Pain Syndrome (CRPS)
confidence interval [CI] 0.34 to 0.90), with an average follow-up
intractable pain, including those who
CRPS
1982
Regional
period of 12.1 +/- 4.6 months.
had subopti
AGED mal results from traditional Lack of functional assessment
Pain Syndrome: A Case
High Frequency (10kHz) SCS
SCS
Conflicts of interest:
ACT
Series of Patients With
Of the 5 patients who had sympathetically independent pain, 3
Dr. Simopoulos has served as a consultant
RELEASED AND
or Without Previous
Senza System, Nevro Corp.,
were responders, and of the 7 patients who had
for Boston Scientific, St. Jude Medical, and
Spinal Cord Stimulator
Redwood City, CA, U.S.A
sympathetically mediated pain, 5 were responders.
Nevro Corp., and for fellow workshops. Dr.
Implantation
Gill has a research grant from Nevro Corp.
BEEN
There were no adverse events.
HEALTH
for programming optimization
Gill, 2019
HAS
OF
Drivers and Risk Factors
The aim of this study was
The primary outcome of interest was the rate of unplanned 30-
Our study suggests that infectious and
Level IV
INFORMATION
of Unplanned 30-Day
to determine drivers of 30-day
day readmissions and associated driving factors. A multivariate
mechanical complications are the
OF
Readmission Following
unplanned readmission
analysis was used to determine independent predictors of
primary drivers of unplanned 30-day
Mechanical complications of SCS device
Spinal Cord Stimulator
following SCS implantation.
unplanned 30-day readmission after SCS implantation.
readmission after SCS implantation,
found to be a main driver for 30-day
Implantation
with obesity as an independent
readmission
Retrospective chart review
We identified 1521 patients who underwent SCS implantation,
predictor of unplanned readmission.
DOCUMENT
Elsamadicy, 2017
n=1521 patients who
with 113 (7.4%) experiencing an unplanned readmission
Conflict of Interest: Shivanand Lad, MD,
FREEDOM
DEPARTMENT
underwent SCS implantation
within 30 days. Baseline patient demographics, comorbidities,
Given the technological
PhD, has received fees for serving as a
THIS
and hospital characteristics were similar between both cohorts. advancements in SCS, repeated studies
speaker and consultant for Medtronic Inc.,
THE THE
are necessary to identify factors
Boston Scientific, and St. Jude Medical. He
The 3 main drivers fo
BY r 30-day readmission after SCS
associated with unplanned 30-day
serves as the Director of the Duke Neuro-
implantation include:
readmission rates after SCS
outcomes Center, which has received
1) infection (not related to SCS device),
implantation to improve patient
research funding from NIH KM1 CA
2) infection due to device (limited to only hardware infection)
outcomes and reduce associated costs
156687, Medtronic Inc. and St. Jude
3) mechanical complication of SCS device.
Medical
Page 15 of 19
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Obesity was found to be an independent predictor of 30-day
readmission
Treatment of
To report a case with two years
N=1 case report, patient with MS implanted with SCS after a
We report the successful treatment of
N/A – case report and narrative literature
Neuropathic Pain and
follow-up of neuropathic pain
successful trial
MS-associated pain and functional
review
Functional
and functional limitations
limitations with an MRI conditional
Limitations Associated
associated with MS effectively
At 24 months follow-up, the patient has had a 77% reduction in
spinal cord stimulator system. The
SCS use in MS has been limited as MS
With Multiple Sclerosis
treated with an MRI conditional
pain and a 99% reduction in opioid use. He had improvement in
ability to obtain post-implant MRI
patients require regular MRI’s and SCS
Using an MRI-
spinal cord stimulator (SCS)
reported tactile sensation, spasticity levels, and ambulation.
imaging of not only the brain but also
devices not always compatible with MRI
Compatible Spinal Cord
system that allowed for spinal
the spinal cord in MS
Stimulator: A Case
imaging.
Post-SCS implant, MRI images at 18 months follow-up provided
patients allows for the continued need
Conflict of Interest: Dr. Provenzano is a
Report With Two Year
To present a comprehensive
the ability to review the spinal cord with minimal artifact. No
to document and follow disease
consultant for Halyard Health, Medtronic,
Follow-Up and
literature review of spinal cord
new MS documented plaques occurred during this time period.
progression, especially with the
St. Jude Medical, and Trevena. Dr. Scott
Literature Review
stimulator utilization in the
advancements in p
CAREharmacological
received research grants and honoraria for
UNDER
treatment of multiple sclerosis
A literature review demonstrated 33 published reports
therapy.
speaking from Teve Neuroscience, Biogen-
Provenzano, 2016
including a total of 496 trialed and 744 implanted patients. Only
Idec, Novartis, and Genzyme
1982
Device: Medtronic SureScan
3 of the reports occurred after the year 2000
AGED
MRI conditional SCS system
ACT
The Parturient With
Retrospective review of 7
Data on these patients before, during, and after
De
AND finitive conclusions cannot be drawn Level IV
RELEASED
Implanted Spinal Cord
patients who had an SCS
labor were collected through chart review and patient
from this small cohort. We believe that
Stimulator
implanted before becoming
interview.
management of a parturient with an
Conflicts/funding not declared
Management and
pregnant
implanted SCS requires careful planning
BEEN
Review of the Literature
Onset of labor varied among the 7 patients (2 preterm and 5
HEALTH between all peripartum physicians
Patient indication for SCS =
term).
HAS
OF
Young, 2015
CRPS
INFORMATION
Mode of anesthesia for delivery included 4 neuraxial
OF
anesthetics, with 3 successfully obtaining an adequate level of
anesthesia for delivery.
Four general anesthetics were administered for cesarean
DOCUMENT
delivery, one of which included a failed attempt at neuraxial
FREEDOM
DEPARTMENT
anesthesia. All infants were born healthy.
THIS
THE THE
One women developed foot drop post partum
BY
References
1. Jones CMP, Shaheed CA, Ferreira G, Mannix L, Harris IA, Buchbinder R, Maher CG. Spinal Cord Stimulators: An Analysis of the Adverse Events
Reported to the Australian Therapeutic Goods Administration. J Patient Saf. 2022 Jan 21. doi: 10.1097/PTS.0000000000000971.
Page 16 of 19
Document 1.2 - FOI 4904
2. O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in
adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2
3. Verrills P, Sinclair C, Barnard A. A review of spinal cord stimulation systems for chronic pain. J Pain Res. 2016 Jul 1;9:481-92. doi:
10.2147/JPR.S108884.
4. Grider JS, Manchikanti L, Carayannopoulos A, Sharma ML, Balog CC, Harned ME, Grami V, Justiz R, Nouri KH, Hayek SM, Vallejo R, Christo PJ.
Effectiveness of Spinal Cord Stimulation in Chronic Spinal Pain: A Systematic Review. Pain Physician. 2016 Jan;19(1):E33-54. PMID: 26752493.
5. Ratnayake CB, Bunn A, Pandanaboyana S, Windsor JA. Spinal Cord Stimulation for Management of Pain in Chronic Pancreatitis: A Systematic Review
of Efficacy and Complications. Neuromodulation. 2020 Jan;23(1):19-25. doi: 10.1111/ner.13051. Epub 2019 Oct 8. PMID: 31595582.
6. Conger A, Sperry BP, Cheney CW, Burnham TM, Mahan MA, Onofrei LV, Cushman DM, Wagner GE, Shipman H, Teramoto M, McCormick ZL. The
Effectiveness of Spinal Cord Stimulation for the Treatment of Axial Low Back Pain: A Systematic Review
CAREwith Narrative Synthesis. Pain Med. 2020
UNDER
Nov 1;21(11):2699-2712. doi: 10.1093/pm/pnaa142. PMID: 32472130.
7.
1982
Odonkor CA, Orman S, Orhurhu V, Stone ME, Ahmed S. Spinal Cord Stimulation vs Conventional Therapies for the Treatment of Chronic Low Back
AGED
and Leg Pain: A Systematic Review of Health Care Resource Utilization and Outcomes in the Last Decade. Pain Med. 2019 Dec 1;20(12):2479-2494.
ACT
doi: 10.1093/pm/pnz185. PMID: 31498396.
RELEASED AND
8. McClure JJ, Desai BD, Ampie L, You W, Smith JS, Buchholz AL. A Systematic Review of the Cost-Utility of Spinal Cord Stimulation for Persistent Low
Back Pain in Patients With Failed Back Surgery Syndrome. Global Spine J. 2021 Apr;11(1_suppl):66S-72S. doi: 10.1177/2192568220970163. PMID:
BEEN
33890806; PMCID: PMC8076810.
HEALTH
9. McNicol E, Ferguson M, Bungay K, Rowe EL, Eldabe S, Gewandter JS, Hayek
OF SM, Katz N, Kopell BH, Markman J, Rezai A, Taylor RS, Turk DC, Dworkin
HAS INFORMATION
RH, North RB, Thomson S. Systematic Review of Research Methods and Reporting Quality of Randomized Clinical Trials of Spinal Cord Stimulation
OF
for Pain. J Pain. 2021 Feb;22(2):127-142. doi: 10.1016/j.jpain.2020.05.001
10. Hayek SM, Veizi E, Hanes M. Treatment-Limiting Complications of Percutaneous Spinal Cord Stimulator Implants: A Review of Eight Years of
Experience From an Academic Center Database. Neuromodulation. 2015 Oct;18(7):603-8; discussion 608-9. doi: 10.1111/ner.12312.
DOCUMENT
11. Smith CA, Roman J, Mammis A. The Role of Spinal Cord Stimulation in Reducing Opioid Use in the Setting of Chronic Neuropathic Pain: A Systematic
FREEDOM
DEPARTMENT
Review. Clin J Pain. 2022 Feb 7;38(4):285-291. doi: 10.1097/AJP.0000000000001021
THIS
12. Baranidharan G, Edgar D, Bretherton B, Crowther
THE T, La
THE lkhen AG, Fritz AK, Vajramani G. Efficacy and Safety of 10 kHz Spinal Cord Stimulation for the
Treatment of Chronic Pain: A Systematic Review and
BY Narrative Synthesis of Real-World Retrospective Studies. Biomedicines. 2021 Feb 11;9(2):180.
doi: 10.3390/biomedicines9020180.
13. Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC,
Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ,
Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-
Page 17 of 19
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kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi:
10.1001/jamaneurol.2021.0538. PMID: 33818600; PMCID: PMC8022268.
14. Eldabe S, Buchser E, Duarte RV. Complications of Spinal Cord Stimulation and Peripheral Nerve Stimulation Techniques: A Review of the Literature.
Pain Med. 2016 Feb;17(2):325-36. doi: 10.1093/pm/pnv025. PMID: 26814260.
15. Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T,
Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for
the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi:
10.1097/ALN.0000000000000774. PMID: 26218762.
16. Baranidharan G, Bretherton B, Montgomery C, Titterington J, Crowther T, Vannabouathong C, Inzana JA, Rotte A. Pain Relief and Safety Outcomes
with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis. Pain Ther.
CARE 2021 Dec;10(2):849-874. doi:
UNDER
10.1007/s40122-021-00269-6. Epub 2021 May 25. PMID: 34031856; PMCID: PMC8586436.
17.
1982
Negoita S, Duy PQ, Mahajan UV, Anderson WS. Timing and prevalence of revision and removal surgeries after spinal cord stimulator implantation. J
AGED
Clin Neurosci. 2019 Apr;62:80-82. doi: 10.1016/j.jocn.2018.12.028. Epub 2019 Jan 14.
ACT
18. Benfield J, Maknojia A, Epstein F. Progressive Paraplegia from Spinal Cord Stimulator Lead Fi
AND brotic Encapsulation: A Case Report. Am J Phys Med
RELEASED
Rehabil. 2016 Mar;95(3):e30-3. doi: 10.1097/PHM.0000000000000411.
19. Rudiger J, Thomson S. Infection rate of spinal cord stimulators after a screening trial period. A 53-month third party follow-up. Neuromodulation.
BEEN
2011 Mar-Apr;14(2):136-41; discussion 141. doi: 10.1111/j.1525-1403.2010.00317.x.
HEALTH Epub 2010 Nov 4
20. Giberson CE, Barbosa J, Brooks ES, McGlothlen GL, Grigsby EJ, Kohut JJ, Wo
OF lbers LL, Poree LR. Epidural hematomas after removal of percutaneous
HAS INFORMATION
spinal cord stimulator trial leads: two case reports. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):73-7. doi: 10.1097/AAP.0000000000000026. PMID:
OF
24310045.
21. Lee SJ, Yoo YM, You JA, Shin SW, Kim TK, Abdi S, Kim KH. Successful removal of permanent spinal cord stimulators in patients with complex regional
pain syndrome after complete relief of pain. Korean J Pain. 2019 Jan;32(1):47-50. doi: 10.3344/kjp.2019.32.1.47. Epub 2019 Jan 2. PMID: 30671203;
DOCUMENT
PMCID: PMC6333578.
FREEDOM
DEPARTMENT
22. Gupta M, Abd-Elsayed A, Knezevic NN. Improving care of chronic pain patients with spinal cord stimulator therapy amidst the opioid epidemic.
THIS
Neurol Sci. 2020 Oct;41(10):2703-2710. doi: 10.
THE 1007/s1
THE 0072-020-04435-0. Epub 2020 May 4. PMID: 32367326.
23. Falowski SM, Celii A, Sestokas AK, Schwartz DM, M
BY atsumoto C, Sharan A. Awake vs. asleep placement of spinal cord stimulators: a cohort analysis of
complications associated with placement. Neuromodulation. 2011 Mar-Apr;14(2):130-4; discussion 134-5. doi: 10.1111/j.1525-1403.2010.00319.x.
Epub 2010 Dec 13. PMID: 21992199.
24. Orhurhu V, Chu R, Orhurhu MS, Odonkor CA. Association Between Pain Scores and Successful Spinal Cord Stimulator Implantation.
Neuromodulation. 2020 Jul;23(5):660-666. doi: 10.1111/ner.13044. Epub 2019 Sep 6. PMID: 31489751.
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25. Gill JS, Asgerally A, Simopoulos TT. High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Complex Regional Pain Syndrome: A Case
Series of Patients With or Without Previous Spinal Cord Stimulator Implantation. Pain Pract. 2019 Mar;19(3):289-294. doi: 10.1111/papr.12739.
Epub 2019 Jan 7. PMID: 30365222.
26. Elsamadicy AA, Sergesketter A, Ren X, Mohammed Qasim Hussaini S, Laarakker A, Rahimpour S, Ejikeme T, Yang S, Pagadala P, Parente B, Xie J, Lad
SP. Drivers and Risk Factors of Unplanned 30-Day Readmission Following Spinal Cord Stimulator Implantation. Neuromodulation. 2018 Jan;21(1):87-
92. doi: 10.1111/ner.12689. Epub 2017 Sep 29. PMID: 28961362; PMCID: PMC5766416.
27. Provenzano DA, Williams JR, Jarzabek G, DeRiggi LA, Scott TF. Treatment of Neuropathic Pain and Functional Limitations Associated With Multiple
Sclerosis Using an MRI-Compatible Spinal Cord Stimulator: A Case Report With Two Year Follow-Up and Literature Review. Neuromodulation. 2016
Jun;19(4):406-13. doi: 10.1111/ner.12409. Epub 2016 Mar 28. PMID: 27019220.
28. Young AC, Lubenow TR, Buvanendran A. The parturient with implanted spinal cord stimulator: managem
CARE ent and review of the literature. Reg
UNDER
Anesth Pain Med. 2015 May-Jun;40(3):276-83. doi: 10.1097/AAP.0000000000000242. PMID: 25899957.
1982
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Page 19 of 19
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OF
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THIS
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BY
Document 3 - FOI 4904
s22
From: s22
@health.gov.au>
Sent: Friday, November 24, 2023 6:46 AM
To: s22
@health.gov.au>; s22
@health.gov.au>
Subject: RE: Spinal cord stimulators [SEC=OFFICIAL]
Great, thanks s22
From: s22
@health.gov.au>
Sent: Friday, 24 November 2023 6:36 AM
To: s22
@health.gov.au>; s22
s22
@health.gov.au>
Subject: RE: Spinal cord stimulators [SEC=OFFICIAL]
CARE
UNDER
Thanks s22
1982
AGED
ACT
Once the post market team have finalized their regulatory decisions I’m sure we will inform
RELEASED AND
TAAD given that was one of the stimulators for the review.
BEEN
s22
HEALTH
HAS INFORMATION
OF
s22
OF
s22
Director Clinical Surveillance Section
Health Products and Regulation Group
DOCUMENT
Department of Health and Aged Care
FREEDOM
DEPARTMENT
On 24 November 2023 at 4:33:34
THIS
am AEST, s22
THE
s22
@health.gov.au
THE
> wrote:
BY
Thanks s22
Yes, a check in re PMRs would be great.
Would be especially good to know if any devices have been taken off the ARTG.
s22
From: s22
@health.gov.au>
Sent: Thursday, 23 November 2023 11:19 PM
To: s22
@health.gov.au>
Cc: s22
@health.gov.au>; s22
s22
@health.gov.au>
Subject: Spinal cord stimulators [SEC=OFFICIAL]
Hi s22
Page 1 of 2
Document 3 - FOI 4904
s22 gave an interesting presentation on the reimbursement side of the medical device
journey at the DCES planning day this week.
One of their projects on the horizon is a review of spinal cord stimulators.
This might be a great opportunity for collaboration given the thorough post market
review conducted by the TGA this year.
Kind regards,
s22
s22
s22
Medical Devices Clinical Section
Medical Devices Authorisation Branch
Email: s22
@health.gov.au
Therapeutic Goods Administration
UNDER CARE
Australian Government, Department of Health and Aged Care
PO Box 100
1982
AGED
Woden ACT 2606
ACT
www.tga.gov.au
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s22
From: s22
@health.gov.au>
Sent: Monday, October 24, 2022 4:17 PM
To: s22
@health.gov.au>
CARE
Subject:
UNDER
(In Confidence) FW: Neurostimulation devices in pain management - new clinical literature
[SEC=OFFICIAL]
1982
AGED
ACT AND
RELEASED
From: s47F
@pha.org.au>
Sent: Thursday, 20 October 2022 11:42 AM
BEEN HEALTH
To: s22
@health.gov.au>
Cc: FLYNN, Elizabeth s22
@health.gov.au
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>
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Subject: FW: Neurostimulation devices in pain management - new clinical literature
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s22
THE
BY
In the context of the post listing review (soon to be?) underway, I thought I should draw your attention to
some new literature on neurostimulators, at:
https://jamanetwork.com/journals/jama/article-abstract/2797419
This is claimed to be the first robust placebo-controlled trial and it shows quite clearly that the procedure is
ineffective (although some of the clinicians have added caveats – see below).
s47F
,
Thanks
s4
7F
Page 1 of 5
Document 4 - FOI 4904
From: s47F
Sent: Thursday, 20 October 2022 5:26 AM
To: s47F
Cc: s47F
@safetyandquality.gov.au>; DUFFY, Tracey
s22
@health.gov.au>; s47F
; s47F
; s47F
@pha.org.au>;
s47F
s22
@health.gov.au>;
s47F
s47F
; s47F
s47F
s47F
s47F
; s47F
; s47F
s47F
>; s47F
Subject: Re: Neurostimulation devices in pain management - Notes from the meeting of May 25th, 2022 -
not for distribution beyond attendees [SEC=OFFICIAL]
Dear s47F ,
There is also the 2021 Cochrane review of spinal neuromoduluation for chronic pain suggesting lack of
efficacy and s47F
. It is not looking good on the efficacy front.
UNDER CARE
Regards
1982
AGED
s47F
ACT
RELEASED AND
s47F
BEEN HEALTH
HAS INFORMATION
OF
OF
DOCUMENT
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THIS
THE THE
BY
From: s47F
Date: Wednesday, 19 October 2022 at 9:47 pm
To: s47F
Cc: s47F
@safetyandquality.gov.au>, "DUFFY, Tracey"
s22
@health.gov.au>, s47F
s47F
s47F
@pha.org.au" s47F
@pha.org.au>, s47F
s22
@health.gov.au>, s47F
s47F
s47F
, s47F
s47F
s47F
s47F
s47F
Page 2 of 5
Document 4 - FOI 4904
s47F
s47F
, s47F
s47F
Subject: Re: Neurostimulation devices in pain management - Notes from the meeting of May 25th,
2022 - not for distribution beyond attendees [SEC=OFFICIAL]
s47F
I think this is a trial of one particular subtype of stimulation pattern ie burst stimulation, for one particular
indication. I think it would be premature to dismiss the entire field of neuromodulation based on one study
for one possible indication however well done the study.
s47F
Sent from my iPhone
On 19 Oct 2022, at 7:40 pm, s47F
wrote:
Dear all,
CARE
UNDER
Things have been very quiet since our meeting, but I thought I should refer you to this spinal
1982
cord stimulator trial published today in JAMA which is very relevant to our previous discussions
AGED
on safety.
ACT AND
RELEASED
https://jamanetwork.com/journals/jama/article-abstract/2797419
BEEN
It is the first robust placebo-controlled trial and it shows quite clearly that the procedure is
HEALTH
ineffective. It would be challenging to justify the risk of harms given the clear lack of benefit.
HAS
OF
INFORMATION
It would be good to hear what ever happened to this review. Perhaps it needs to be
OF
reinvigorated.
Regards
DOCUMENT
DEPARTMENT
FREEDOM
s47F
THIS
THE THE
BY
s47F
Page 3 of 5
Document 4 - FOI 4904
From: s47F
@safetyandquality.gov.au>
Date: Friday, 8 July 2022 at 2:23 pm
To: "DUFFY, Tracey" s22
@health.gov.au>, s47F
, s47F
, s47F
, s47F
@pha.org.au"
s47F
@pha.org.au>, s47F
s47F
, s47F
s22
@health.gov.au>, s47F
, s47F
, s47F
, s47F
s47F
, s47F
s47F
" s47F
, s47F
Cc: s47F
s47F
Subject: Neurostimulation devices in pain management - Notes from the meeting of May
25th, 2022 - not for distribution beyond attendees [SEC=OFFICIAL]
CARE
UNDER
Good afternoon,
1982
AGED
Please find attached the notes from the Neurostimulation devices in pain management
ACT
meeting held in May and two presentations from that meeting.- thank you for your
RELEASED AND
participation.
BEEN
If you have any enquiries in regard to the meeting please get in touch.
HEALTH
HAS INFORMATION
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Thank you
OF
s47F
s47F
s47F
DOCUMENT
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Document Outline
