Neurostimulation System Components and Implantation
How Neurostimulation Controls Pain
Benefits of Neurostimulation
The Medtronic Family of Premium Neurostimulation Systems
RESTOREULTRA™
RESTOREADVANCED™ and
PRIMEADVANCED™ Neurostimulators
Historical Background

There are two types of neurostimulation systems: one that is completely internal (surgically implanted) and one with both internal and external components. For a totally implantable neurostimulation system, the power source (battery) and lead(s) are surgically implanted.

In the other type of system, a radio-frequency receiver and leads are implanted, and the power source is worn externally with an antenna over the receiver.

• One or two leads which deliver electrical stimulation to the spinal cord or targeted peripheral nerve (See Important Safety Information and Risks for specific indications)
• An extension wire which conducts electrical stimulation from the power source to the lead
• A power source which generates the electrical stimulation

The neurostimulation system is typically implanted in a two-stage procedure, separated by a trial screening period lasting approximately 1 to 10 days. Stage 1 involves implantation of a lead for trial screening, and Stage 2 involves implantation of the complete neurostimulation system (either the totally implantable system or the radio-frequency system). (See the Screening and Implant Techniques section for more information.)

How Neurostimulation Controls Pain

Neurostimulation delivers low voltage electrical stimulation to the spinal cord or targeted peripheral nerve to block the sensation of pain. One theory, the Gate Control Theory of pain developed by researchers Ronald Melzack and Patrick Wall, proposes that neurostimulation activates the body's pain inhibitory system. According to this theory, there is a gate in the spinal cord that controls the flow of noxious pain signals to the brain. The theory suggests that the body can inhibit these pain signals or "close the gate" by activating certain non-noxious nerve fibers in the dorsal horn of the spinal cord. The neurostimulation system, implanted in the epidural space, stimulates these pain-inhibiting nerve fibers, masking the sensation of pain with a tingling sensation (paresthesia).^1,2

Neurostimulation may be the appropriate treatment for the management of certain chronic pain conditions, including: Failed Back Syndrome (FBS), Complex Regional Pain Syndrome (CRPS), and arachnoiditis. (See the Patient Selection section for a more detailed list of conditions and Important Safety Information and Risks for specific indications.)

²Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: Preliminary clinical report. Anesth Analg. 1967; 46(4):489-91.

Benefits of Neurostimulation

• Improve pain relief (a majority of patients may experience at least 50 percent reduction in pain)^1,2,3
• Increase activity levels^1,2,3,4
• Reduce use of narcotic medications^2,3,4

These results may also lead to reduced hospitalizations and surgical procedures, reduced health care costs, greater independence, and improved quality of life.^2,3,4

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The Medtronic Family of Premium Neurostimulation Systems

Medtronic offers you the broadest variety of neurostimulation systems to relieve chronic pain. Our premium neurostimulators — RestoreULTRA™, RestoreADVANCED® and PrimeADVANCED®— provide programming enhancements to help you quickly identify the settings that provide optimal relief.

The following programming features are included on all Medtronic premium neurostimulators.

TARGETSTIM™

• Steers stimulation along or between leads to help find optimal target and settings
• Automates multiple programming steps

TARGETmySTIM™

• Empowers your patients to steer their electrode array to keep therapy on target if their pain patterns change

AUTOFILL™

• Easy-to-use interface automatically generates additional groups based on existing groups

GROUPADJUST™

• Patients can simultaneously increase or decrease all program amplitudes in a group

OPTIMIZER™

• Fine-tunes stimulation using electrode combinations a trained clinician might use

PROGRAM myStim®

• Allows for review of stimulation settings of all programs in a group
• Provides for name or icon identification of groups

myStim® DIARY

• Identifies stimulation use patterns
• Identifies successful stimulation for an activity or time of day
• Allows for review of groups, number of patient adjustments, and stimulation ON periods
  

• The myStim Patient Programmer puts patients in control, within certain parameters. The programmer increases patients' ability to identify and manage therapy with easy-to-understand icons or text options and allows them to become familiar with the patient programmer during the trial. When activated, the GROUPADJUST feature allows patients to simultaneously increase or decrease all program amplitudes in a group.

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RestoreULTRA

ULTRA Smart Neurostimulator
RestoreULTRA is the latest addition to the Medtronic family of neurostimulation systems. At 22cc it is our smallest and smartest rechargeable neurostimulation system, allowing you to steer the electrode array and for the first time empowering patients to move stimulation on their own.

RestoreULTRA was designed to help you target the sweet spot and relieve complex pain:

• Flexible

• RestoreULTRA is the smallest and thinnest 16-electrode neurostimulator on the market, providing more implant options—even in smaller patients

• New programming tools released with RestoreULTRA also may be used with RestoreADVANCED and PrimeADVANCED

• Powerful

• Medtronic expands the limits with RestoreULTRA. It offers an amplitude of up to 10.5V, a rate of up to 1,200 HZ, and a pulse width of up to 1,000 microseconds—powerful parameters to drive effective therapy

• An average recharge interval of approximately two weeks* eliminates the need for daily charging. Patients can remain mobile when they recharge

• Focused

• With RestoreULTRA you target the sweet spot to relieve complex pain using the most sophisticated leads and powerful electrode array configuration technology

• TARGETSTIM™—Smoothly steers stimulation along or between multiple leads

• TARGETmySTIM™—For the first time, empower your patients with the ability to easily steer their electrode array to keep therapy on target if pain patterns change

• Leading Technology

• Choose from a wide range of leads and extensions, including the SPECIFY™ 5-6-5 surgical lead with 16-independently programmable electrodes. The Medtronic comprehensive portfolio of leads and extensions paired with RestoreULTRA allows you to:

• Treat concurrent pain sites

• Adapt to changing pain patterns

• Target the midline

• Address lead migration

*Recharge intervals vary based on parameter settings.

For more information visit www.restoreultra.com

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RESTOREADVANCED™ and PRIMEADVANCED™ Neurostimulators

Targeting Pain Relief…with Accuracy and Simplicity

RESTOREADVANCED and PRIMEADVANCED provide powerful, yet simple programming features, making the management of chronic pain easier for you and your patients.

Chronic Pain…Under Control

RESTOREADVANCED and PRIMEADVANCED are characterized by the ease and efficiency with which they can be programmed to help relieve chronic pain. For clinicians, that means establishing settings quickly. For people with pain, it's the ability to easily select from multiple groups to find the therapy that offers greatest comfort.

With the ADVANCED line of neurostimulators, programming is made easier with:

• Fewer programming keystrokes
• Greater patient understanding of group settings
• Simplified customization options
• One-touch patient therapy adjustments
• Easy-to-understand icons and text options for identifying and managing groups

Two Neurostimulators…One Approach to Relieving Pain

RESTOREADVANCED Neurostimulator

• Rechargeable
• Longest FDA-approved battery life on the market
• 16 electrodes
• Most flexible ambulatory recharge system
• Unparalleled programmability

PRIMEADVANCED Neurostimulator

• Non-rechargeable
• Smallest 16-electrode non-rechargeable neurostimulator
• Unparalleled programmability
  
  

Programming Pain Relief with myStim®

• The myStim Patient Programmer puts patients in control, within certain parameters. Compatible with RESTOREADVANCED and PRIMEADVANCED, as well as the ENS, the programmer increases patients' ability to identify and manage groups with easy-to-understand icons or text options and allows them to become familiar with the patient programmer during the trial. When activated, the GROUPADJUST feature allows patients to simultaneously increase or decrease all program amplitudes in a group.

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Historical Background

Medtronic engineers and C. Norman Shealy, M.D., developed the first neurostimulation system in the 1960s. Since the first system was implanted in 1967, neurostimulation technology has undergone significant advancements, including refinements in patient selection criteria, and equipment design, flexibility, reliability, and lifespan. Medtronic's neurostimulation systems have helped thousands of chronic pain patients lead more comfortable and productive lives.

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Neurostimulation System Components and Implantation
How Neurostimulation Controls Pain
Benefits of Neurostimulation
The Medtronic Family of Premium Neurostimulation Systems
RESTOREULTRA™
RESTOREADVANCED™ and
PRIMEADVANCED™ Neurostimulators
Historical Background