About the Therapy Spinal Cord Stimulation

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.

Spinal cord stimulation may be:

  • An effective alternative when conventional therapies and systemic pain medications provide inadequate pain relief or intolerable side effects
  • More cost-effective than CMM in the long term3,6, and generally covered and paid for by payers nationwide1

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 relief2,4,6
  • Improved quality of life2,4
  • More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery5
  • Successful pain disability reduction4
  • More cost-effective than conventional medical management and reoperation3,6,7
  • Multiple studies have also provided clinical evidence to suggest some patients treated with spinal cord stimulation may be able to reduce oral opioid consumption.10,11,12 

POTENTIAL RISKS

The most frequently reported problems following the surgery to implant a neurostimulation system include infection, lead movement, pain at the implant site, loss of therapy effect, and therapy that did not meet the patient's expectations. Refer to Indications, Safety, and Warnings for more details.

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.

  • Better Pain Relief — From AdaptiveStim™ technology to DTM™ SCS therapy, Medtronic offers proven ways to provide personalized pain relief.8,9
  • Unmatched MRI Access — Medtronic neurostimulators offer SureScan™ MRI technology enabling patients safe MRI scans on any part of the body.*
  • Unrivaled Device Performance — Intellis™ rechargeable offers 95% capacity at 9 years and Vanta™ recharge-free neurostimulator offers ~2x more longevity than competitive PC devices at comparable settings13
  • Objective Outcome Data — Real-time insights captured in Snapshot™ reporting help transform patient conversations from subjective to objective.

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
LEARN ABOUT Neurostimulators
A close-up image of the Vanta and Intellis platforms
*

MR Safety Triangle Under specific conditions and requires SureScan™ MRI implantable neurostimulator and leads. Refer to product labeling for full list of conditions.

1

Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). www.cms.gov. Accessed March, 2017. 

2

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. 

3

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. 

4

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. 

5

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. 

6

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.

7

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. 

8

Schultz D, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15(1):1-12. 

9

Fishman: Fishman M, Cordner H, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of Differential Target Multiplexed™ SCS (DTMTM SCS) in Treating Intractable Chronic Low Back Pain: Long-term Follow-Up Results. Presented at: North American Neuromodulation Society 24th Annual Meeting. Jan 15-16, 2021. Virtual. 

10

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]).

11

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)

12

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).

13

Settings used from Abbott Proclaim™ clinician manual. Nominal settings 12 hours per day: 50-Hz frequency, 225-μs pulse width, and 5-mA amplitude at 500-ohms impedance. Compared to flagship model 3660. Settings from Boston Scientific’s AlphaTM IFU. Programmed at 4.1mA, 280us, 40 Hz, 1 area, 730 Ohms, 2 contacts.