Spinal Cord Stimulation

• Preference for Voltage or Current Stimulation Pulse Trains is not Consistent in Patients Undergoing Spinal Cord Stimulation (SCS) trial - #161

In this IRB-approved multicenter feasibility study, patients (n = 14; 5 male, 9 female) undergoing SCS trial participated in a single in-clinic study. An external neurostimulator (ENS), Model 37021 NP with firmware modified from the commercially available Model 37021 SCS screener was used to deliver stimulation to the externalized trial leads.

J. Sasaki, C.M. Schade, D. Schultz, J. Greenberg, L.M. Johanek, G. King
Medtronic Inc., AAPM Clinical Poster, 2009

• Quality of Life, Resource Consumption and Costs of Spinal Cord Stimulation Versus Conventional Medical Management in Neuropathic Pain Patients with Failed Back Surgery Syndrome (PROCESS Trial).

In selected patients with FBSS, treatment with SCS +CMM resulted in pain relief that is sustained at 24 months and is associated with clinically important improvement in functional capacity, health-related quality of life and patient satisfaction.

Andrea Manca, Krishna Kumar, Rod S. Taylor, Line Jacques, Sam Eldabe, Mario Meglio, Joan Molet, Simon Thomson, Jim O'Callaghan, Elon Eisenberg, Germain Milbouw, Eric Buchser, Gianpaolo Fortini, Jonathan Richardson, Rebecca J. Taylor, Ron Goeree, Mark J. Sculpher
European Journal of Pain, 2008

• Method for Smoothly Shifting Electric Stimulation Field Along a Lead Using Interleaved Pulses

A novel method of shifting an arbitrary electrode configuration along a lead using interleaved stimulation pulses in a manner that provides consistently comfortable paresthesia is described and clinical data are presented.

Steve Goetz, MS; Jeff Keacher; Gabi Miyazawa, MS; Jordan Greenberg, PhD
Medtronic Inc., Presented at NANS, 2006

• Prospective Outcomes Study on the Restore Rechargeable Neurostimulation System for Neuropathic Pain: A Multicenter Study

This report details 2 prospective, multicenter studies involving similar indications. The Restore Study captured important measures in addition to pain relief such as: functional improvement, quality of life, patient satisfaction, ease of recharge, and physician satisfaction with 98% of patients contributing data.

J. P. Van Buyten, MD¹; S. Fowo, MD²; G. H. Spincemaille, MD, PhD³; V. Tronnier, MD, PhD⁴; M. Schrey, MD⁵; G. Beute, MD⁶; J. J. Pallarés, MD⁷; H. Naous, MD⁸; F. Zucco, MD⁹;J. K. Krauss, MD, PhD¹⁰; U. Friess, MD¹¹; J. De Andrés, MD, PhD¹²; E. Buchser, MD¹³; A. Costantini, MD¹⁴; Y. Lazorthes, MD, PhD²

1. Multidisciplinary Pain Center, AZ Nikolaas Hospital, Sint-Niklaas, Belgium; 2. CHU Rangueil, Toulouse, France; 3. Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands; 4. Universitätsklinik Schleswig-Holstein Campus Lübeck, Lübeck, Germany; 5. Universitätsklinikum Heidelberg, Heidelberg, Germany; 6. St. Elisabeth Ziekenhuis, Tilburg, The Netherlands; 7. Hospital Universitario La Fé, Valencia, Spain; 8. Hôpital Neurologique et Neurochirurgical Pierre Wertheimer, Lyon, France; 9. AZ Ospidale Garbagnate, Garbagnate, Italy; 10. Medizinische Hochschule Hannover, Hannover, Germany; 11. Klinikum Mannheim, Mannheim, Germany; 12. Hospital General de Valencia, Valencia, Spain; 13. Hôpital de Morges, Morges, Switzerland; 14. Ospedale Clinicizzato SS. Annunziata, Chieti, Italy

• Restore vs. Precision

This report details 2 prospective, multicenter studies involving similar indications. The Restore Study captured important measures in addition to pain relief such as: functional improvement, quality of life, patient satisfaction, ease of recharge, and physician satisfaction with 98% of patients contributing data.

Van Buyten JP, Fowo Sylvain, Spincemaille GH, Oakley JC, Krames ES, Prager JP, et al.
Medtronic Inc., 2008

• Restore Clinical Study Key Findings Demonstrating Significant Improvements in Quality of Life, Pain, and Function

The first prospective, multicenter, longitudinal neurostimulator outcome clinical study for the Restore Neurostimulation System demonstrates statistically significant improvements in quality of life, pain relief, function, and patients' ease of recharging the device.

Restore^® Rechargeable Neurostimulator Study, Protocol Number 1615, Final Results Report, October 18, 2006. Data on file at Medtronic, Inc.

• Neurostimulation for Complex Regional Pain Syndrome Literature Summary

The referenced long-term clinical studies have shown that SCS provides statistically significant pain relief in patients with CRPS. Economic studies show that as compared to the conventional medical management of patients with CRPS, SCS should become cost-effective after about 2 years of its use.

This Literature Review was authored by Douglas E. Busby, MD. Dr. Busby, a former Medicare contractor medical director, is a Medtronic consultant.

Medtronic Inc., 2007

• Neurostimulation for Failed Back Surgery Syndrome Literature Summary

The long-term clinical studies that are summarized in this review have shown that SCS is effective in controlling pain associated with FBSS.

Kumar K, North RB, Dario A, Leveque J-C, Ohnmeiss DD, Rashbaum RF, Devulder J, Rainov NG, Fiume D, De La Porte C, Van de Kelft E, Taylor RJ, Taylor RS, Bell GK, et al.

This Literature Review was authored by Douglas E. Busby, MD. Dr. Busby, a former Medicare contractor medical director, is a Medtronic consultant.

Medtronic Inc., 2008

• Prevention and Management of Intrathecal Drug Delivery and Spinal Cord Stimulation System Infections

Available data indicate that implantable DD and SCS device infections share important features with other surgical site infections (SSIs). These SSIs include those that affect cerebrospinal fluid (CSF) shunts and electrophysiologic cardiac devices such as implantable pacemakers and cardioverter–defibrillators (ICDs).

Follett KA, Boortz-Marx RL, Drake JM, et. al.
Anesthesiology, 2004

• The Case for Spinal Cord Stimulation for Complex Regional Pain Syndrome (CRPS)

This document presents the Medtronic response to the Kemler New England Journal of Medicine Correspondence.

Medtronic Inc., 2004

• Computer Modeling of Spinal Cord Stimulation for Low Back Pain

Although no clinical evidence exists yet to support the results presented in this discussion, modeling data indicate that a 3-lead configuration with strategic placement of anodes around a single cathode may facilitate a higher degree of control over the electrical fields produced during spinal cord stimulation for low back pain. Other investigators have published similar findings.

Barolat G, Massaro F, He J, Zeme S, Ketcik B, Caraway D, Miyazawa G, Greenberg J, King G, Feirabend HK, Choufoer H, Ploeger S, Holsheimer J, van Gool JD, Holsheimer J, den Boer JA, Struijk JJ, Rozeboom AR, Tas NR, Wesselink WA, Law JD, McIntyre CC, Richardson AG, Grill WM, McNeal DR, Melzack R, Wall PD, North RB, Kidd DH, Olin J, Prager JP, Chang JH, Ross EL, Schade CM, Stojanovic MP, Abdi S, Stojanovic MP, Abdi S, et al.

Medtronic Inc., 2007

• Differential Effects of Spinal Cord Stimulation Are Achieved with Three-Lead Patterns

Three-column patterns with different electrode spacings can be studied using computer models by determining the effect of a particular electrode configuration on fiber selectivity and energy consumption.

Gabriela Miyazawa, MS; Jordan Greenberg, Phd; Gary King, PhD
Medtronic Inc., 2007

• Heat Flow from Rechargeable Neuromodulation Systems into Surrounding Media

A synergistic investigation involving both experiment and numerical simulation was performed in vitro to determine the heat flow from rechargeable neuromodulation systems into surrounding media. Each system investigated consists of an implant and an external recharging antenna.

Jacob J. Weinmann and Ephraim M. Sparrow
University of Minnesota, 2007

• Three-Column Surgical Lead for Spinal Cord Simulation Offers Selective Dorsal Column Fiber Activation

Three-lead arrays for spinal cord stimulation allow anodes to be placed longitudinally and laterally with respect to a central cathode and allow for an increased therapeutic range. Three-column electrode configurations have become increasingly popular with the recent introduction of tripolar surgical leads on the market.

Michael Turner, MD¹, Gabriela Miyazawa, MS², Sean Skubitz², Kristin Schneider², Kevin Tidemand²

1. Indianapolis Neurosurgical Group of Indianapolis, 2. Medtronic Inc.