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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.
Published studies have shown that when used by carefully selected patients with chronic pain, spinal cord stimulation may offer the following benefits:
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.
A spinal cord stimulation system consists of two implanted components:
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:
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.
Spinal cord stimulation may benefit certain patients who meet the following criteria:
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:
Medtronic offers standardized guidance for trialing spinal cord stimulation, including DTM™ SCS Therapy, a proprietary therapy of Medtronic.
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.
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
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:
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
of patients improved in degree of disability
at 12-month follow up12
Meaning ODI scores
of patients were
satisfied with therapy12
years of recharge-free longevity
estimated using actual
12-month programming data14
estimated daily rapid recharge
or recharge less frequently
(1 hour every 12 days)14
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.
more likely to
of patients experienced treatment success after receiving SCS therapy
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.
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.
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.
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.
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.
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.
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.
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]).
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)
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).
R131649 RS2 Lithium-Ion Overdrive™ Rechargeable Battery DVT Report
Instructions For Use
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.
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.
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.
Medtronic. Medtronic Pain Therapy Clinical Summary M221494A016 Rev B. United States; 2022.
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.
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.
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.