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

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 — 88.7%* of patients reported better pain relief with AdaptiveStim vs. conventional stimulation8,9
  • Access to MRI Scans on Any Part of the Body — Medtronic pain neurostimulation systems provide safe access to 1.5 Tesla MRI scans on any part of the body. (MR Safety Triangle Under specific conditions. Requires SureScanTM MRI implantable neurostimulator and lead/s. Refer to MRI Guidelines for the full list of conditions.)
  • Quality and Safety — Medtronic has more than 30 years of experience innovating, refining, and implementing neurostimulator technologies. View product performance data.

COMPONENTS OF A 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

SCS Product Family - RestoreSensor, MyStim, NVision

The external components to a spinal cord stimulation system allow the therapy to be customized for each patient:

  • 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
*

RestoreSensor© Clinical Study compared AdaptiveStim stimulation to Medtronic conventional stimulation; 88.7% is based on analysis of one of two questions that comprised the primary endpoint of improved convenience and/or better pain relief. Percentage based on respondents who completed the pain relief question.

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

Medtronic advanced pain therapy using neurostimulation for chronic pain. Clinical Summary, 2014. M221494A009. 

9

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.