About the therapy
An intervention for chronic back and/or leg pain
As an intervention for chronic back and/or leg pain, spinal cord stimulation can be an effective alternative or adjunct treatment to other therapies that have failed to manage pain on their own. An implantable spinal cord stimulator delivers small electrical signals through a lead implanted in the epidural space. Pain signals are inhibited before they reach the brain. Instead of pain, patients may feel pain relief.
Potential benefits
Published studies have shown that when used by carefully selected patients with chronic pain, spinal cord stimulation may offer the following benefits:
- Long-term pain relief1,2,3
- Improved quality of life1,2
- More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery4
- Successful pain disability reduction2
- More cost-effective than conventional medical management and reoperation5,3,6
- Multiple studies have also provided clinical evidence to suggest some patients treated with spinal cord stimulation may be able to reduce oral opioid consumption.7-9
Medtronic advantages
Medtronic's steadfast commitment to safety, testing, and reporting has led to the development of some of the industry's most widely used neurostimulation devices.
- Real-time sensing-enabled dosing means you can be confident that the delivered therapy is instant, precise and truly individualized to each patient.*
- Full-body 1.5T and 3T MRI† means you can be certain patients have access to an MRI if needed.
- Longest-lasting battery with 95% capacity at 15 years means you can be assured of its reliable performance.10
- Smallest fully implantable sensing SCS device means you can trust it’s designed for patient comfort.11
Unmatched full-body MRI access
- SureScan™ MRI technology allows MRI scans anywhere on the body† enabling diagnostic care.
- Provide patients the same access as non-implanted patients† — now and in the future.
- Shielded leads and proprietary device safeguards help patients safely get an MRI.†
- Access matters — 98% of patients are expected to need at least 1 MRI within 10 years of implant.3
Components of Spinal Cord Stimulation System
A spinal cord stimulation system consists of two implanted components:
- Neurostimulator — Rechargeable or non-rechargeable implanted power source that generates electrical pulses according to programmable neurostimulation parameters and features
- Lead — A set of thin wires with a protective coating and electrodes near the tip (percutaneous lead) or on a paddle (surgical lead). The electrodes transmit the electrical pulses to the stimulation site
- Clinician Programmer — Used to program the implanted neurostimulator
- Patient Programmer — Empowers patients by giving them a way to manage their pain relief — within preset physician parameters — to optimize outcomes
- Wireless External Neurostimulator — Mimics the therapy delivered by the implantable neurostimulator
Patient selection
Candidates for spinal cord stimulation
The overall goal for patient selection for spinal cord stimulation is to choose those patients most likely to experience therapeutic success while reducing the likelihood of risks, complications, and adverse events. A careful assessment by a multidisciplinary team, and discussion of the patient's expectations and goals, will help identify appropriate candidates for spinal cord stimulation.
Spinal Cord Stimulation is an aid in the management of chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following conditions:
- Failed Back Syndrome (FBS) or low back syndrome or failed back
- Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk
- Postlaminectomy pain
- Multiple back operations
- Unsuccessful disk surgery
- Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions
- Peripheral causalgia
- Epidural fibrosis
- Arachnoiditis or lumbar adhesive arachnoiditis
- Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia
The safety and effectiveness of this therapy has not been established for pregnancy, unborn fetus or delivery.
If a patient does not respond well to neurostimulation, he or she may be a candidate for Targeted Drug Delivery.
Patient selection for spinal cord stimulation
Spinal cord stimulation may benefit certain patients who meet the following criteria:
- Chronic, intractable pain of the trunk and/or limbs
- No contraindications to therapy or surgery
- Patient can properly operate system
- Patient understands therapy risks
- Satisfactory results from test stimulation
- Patient is not pregnant
- Clearance and completion of psychological evaluation
- 18 years of age or older
- They are appropriate candidates for surgery
- Their symptoms are of physiological origin
Screening trial
A screening trial allows patients to assess their response to spinal cord stimulation prior to device implantation. Patients who experience adequate pain relief from the screening trial may be candidates for an implanted neurostimulation system.
The screening trial:
- Offers an opportunity to gauge patient response prior to device implantation
- May last for up to 10 days
Medtronic offers standardized guidance for trialing spinal cord stimulation, including DTM™ SCS Therapy, a proprietary therapy of Medtronic.
DTM™ SCS therapy
Building on the foundation of Differential Target Multiplexed™ (DTM) spinal cord stimulation (SCS), DTM™ SCS therapy is an energy modified differential target multiplexed therapy offering meaningful pain relief, satisfaction, and quality of life improvements.12 This enables you to personalize care for those seeking recharge-free longevity or less frequent recharging.
Inspired by science
DTM™ SCS therapy options are inspired by decades of basic science research and preclinical understanding. In a preclinical study, the DTM™ programming (DTMP) derivatives modulated neuro-inflammatory processes more than low-rate SCS.‡,13
Clinical results show meaningful pain relief
Study objectives
DTM™ SCS therapy study is a prospective, multicenter, single-arm study designed to evaluate the long-term efficacy and energy use of DTM™ SCS therapy.1
Primary objective: To evaluate the effectiveness of DTM™ SCS therapy in reducing overall pain intensity at 3-months follow up.
Secondary objectives with follow up to 12-months:
- Characterize changes in pain intensity for overall, back, and leg pain
- Characterize programming parameters associated with energy use
- Characterize changes in functional disability as measured by Oswestry disability index (ODI)
- Characterize subject satisfaction
- Characterize therapy safety data
12-Month Outcomes
Meaningful
pain relief
4.6
cm reduction in VAS for overall pain
from baseline to 12 months12
Mean overall VAS
Note: *Subjects were excluded from analysis at 6-Months due to programming changes from DTM™ SCS therapy (N=1) and due to study exit (N=1). **Subjects were excluded from analysis at 12-Months due to programming changes from DTM™ SCS therapy (N=2) and due to study exit (N=1)
Meaningful quality of
life improvements
76%
of patients improved in degree of disability
at 12-month follow up12
Meaning ODI scores
Therapy satisfaction
86%
of patients were
satisfied with therapy12
Long lasting
5½-7½
years of recharge-free longevity
estimated using actual
12-month programming data14
Save time
5 minutes
estimated daily rapid recharge
or recharge less frequently
(1 hour every 12 days)14
SCS for Diabetic neuropathy
Help your patients control the debilitating pain in their feet and legs.
For patients who experience chronic pain due to DPN and have not been satisfied by the levels of relief provided by oral pain medication, injections, or other treatments for pain, SCS can provide a new approach for patients looking for solutions.
Potential benefits of SCS therapy
- Patients with DPN are 17 times more likely to experience significant pain relief if treated with SCS compared to conventional treatment.15-17
- 86% of patients experienced treatment success after receiving SCS therapy for one-year‡,18
- Proven long-term therapy for managing chronic pain with the majority of patients experiencing meaningful pain relief through five years of treatment with SCS.18
17x
more likely to
experience significant
pain relief15-17
86%
of patients experienced treatment success after receiving SCS therapy
for 1-year‡,18
5yrs
of meaningful
pain relief18
Understand the risks
Risks include infection, lead movement, pain at the implant site, and loss of therapy effectiveness. Not everyone responds to SCS in the same way, and your patients’ experiences may vary. Risk of infection and severity of complications may be greater in diabetic patients.
Consider a preoperative risk assessment to determine if patients are healthy enough for surgery.
Monitor patients' glucose levels.
*
Success rates in a population of patients treated with SCS in two studies and followed for five years.
†
Under specific conditions. Refer to product labeling for full list of conditions. Patients with non-Medtronic leads and an EMBSNV20 adaptor extension are not eligible for an MRI.
‡
Note: Data obtained from animal studies should not be extrapolated to clinical/human results.
1
Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4):762-770;discussion 770.
2
Harke H, Gretenkort P, Ladleif HU, Rahman S. Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. Eur J Pain. 2005:9(4);363-373.
3
Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M. Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial. J Neurosurg. 2008;108(2):292-298.
4
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-107.
5
North RB, Kidd D, Shipley J, Taylor RS. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007;61(2):361-369.
6
Taylor RJ, Taylor, RS. spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess Health Care. 2005;21(3):351-358.
7
Gee L, Smith HC, Ghulam-Jelani Z, et al. Spinal Cord Stimulation for the Treatment of Chronic Pain Reduces Opioid Use and Results in Superior Clinical Outcomes When Used Without Opioids. Neurosurgery. 2018. A nonrandomized prospective cohort study of SCS patients between September 2012 and August 2015 (N=86 [n=53 on opioids]).
8
Sharan AD, Riley J, Falowski S, et al. Association of Opioid Usage with Spinal Cord Stimulation Outcomes. Pain Med. December 2017. A non-randomized analysis of Truven Health Marketscan databases from January 2010 to December 2014 based on the first occurrence of an SCS implant (N= 5,476)
9
Pollard EM, Lamer TJ, Moeschler SM, et al. The effect of spinal cord stimulation on pain medication reduction in intractable spine and limb pain: a systematic review of randomized controlled trials and metaanalysis. Journal of Pain Research. 2019:12 1311–1324. A research review summarising SCS studies with respect to opioid use and a further metaanalysis of comparative SCS RCTs of 1 year or greater duration (N=489).
10
R131649 RS2 Lithium-Ion Overdrive™ Rechargeable Battery DVT Report
11
Instructions For Use
12
Provenzano, Peacock, Fishman, et al. A prospective multi-center study of a reduced-energy DTM™ stimulation derivative: Long-term outcomes in therapy naïve patients. Poster presented at: American Society of Regional Anesthesia and Pain Medicine (ASRA) Annual Pain Medicine Meeting; Nov. 17–19, 2022; Orlando, FL, USA.
13
Cedeno D, Vallejo R, Platt D, et al. Differential target multiplexed SCS using reduced energy parameters in an animal model of neuropathic pain. Poster presented at: American Society of Pain and Neuroscience (ASPN) annual meeting. July 22&nash;25, 2021.
14
Provenzano, Amirdelfan, Grewal, et al. Modeling energy demands of a reduced-energy derivative of DTM™ stimulation on rechargeable and recharge-free SCS systems. Poster presented at: American Society of Regional Anesthesia and Pain Medicine (ASRA) Annual Pain Medicine Meeting; Nov. 17–19, 2022; Orlando, FL, USA.
15
Medtronic. Medtronic Pain Therapy Clinical Summary M221494A016 Rev B. United States; 2022.
16
de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: A multicenter randomized clinical trial. Pain. 2014;155(11):2426–2431. doi:10.1016/j.pain.2014.08.031.
17
Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: A prospective two-center randomized controlled trial. Diabetes Care. 2014;37(11):3016–3024. doi:10.2337/dc14-0684.
18
van Beek M, Geurts JW, Slangen R, et al. Severity of neuropathy is associated with long-term spinal cord stimulation outcomes in painful diabetic peripheral neuropathy: Five-year follow-up of a prospective two-center clinical trial. Diabetes Care. 2018;41(1):32–38. doi:10.2337/dc17-0983.
See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. [If using an MRI SureScan™ device, see the MRI SureScan™ technical manual before performing an MRI].
For further information, contact your local Medtronic representative.