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Spinal Cord Stimulation

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  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • PrimeAdvanced SureScan MRI Neurostimulator

    View all SCS products

    Features and Specifications

    Summary

    PrimeAdvanced® is a powerful, multi-programmable, nonrechargeable neurostimulator that is part of a spinal cord stimulation system for chronic pain.

    PrimeAdvanced SureScan MRI allows patients safe* access to an MRI scan anywhere on the body. Filtered feedthrough technology developed and offered only by Medtronic protects the neurostimulator by preventing RF energy from entering the device and damaging internal circuitry and components.1 Medtronic SureScan MRI Technology eliminates the need to perform an inconvenient and costly explantation.

    Learn more about SureScan MRI Technology

    The PrimeAdvanced SureScan MRI neurostimulator delivers stimulation through 1 or more leads in the epidural space as an intervention for chronic back and/or leg pain. Multiple or single stimulation programs are available. This spinal cord stimulation system is appropriate for use for bilateral and complex pain patterns and low energy requirements (using multiple stimulation programs), or for simple pain patterns (using one stimulation program).

    PrimeAdvanced SureScan MRI offers the convenience of a non-rechargeable device for patients who are not good candidates for rechargeable neurostimulators.

    *Under specific conditions and requires SureScan implantable neurostimulator and Vectris® SureScan leads. Refer to MRI Guidelines for full list of conditions.

    References
    1. MRI Standard Letter, Spinal Cord Stimulation Systems, 2011.

    Indications and Contraindications

    Indications

    A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) as 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:

    • Failed Back Syndrome (FBS) or low back syndrome or failed back
    • Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk
    • Postlaminectomy pain
    • Multiple back operations
    • Unsuccessful disk surgery
    • Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions
    • Peripheral causalgia
    • Epidural fibrosis
    • Arachnoiditis or lumbar adhesive arachnoiditis
    • Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia

    Contraindications

    Diathermy – Do not use shortwave diathermy, microwave, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted electrodes, resulting in severe injury or death.

    Specifications

    Physical Specifications
    Height 65 mm (2.6 in)
    Length 49 mm (1.9 in)
    Thickness 15 mm (0.6 in)
    Weight 67 g (2.4 oz)
    Volume 39 cc
    Battery Life Depends on settings and use
    Maximum Electrodes 16
    Rate 3-130 Hz
    Pulse Width 60-450msec
    Amplitude 0-10.5 V
    Battery Type Primary cell
    Groups 26
    Programs 32
    Lead Array Options 1-4
    Implant Depth ≤ 4 cm

    Features

    PrimeAdvanced® SureScan® MRI neurostimulator is a powerful, nonchargeable device that offers unparalleled programmability.

    PrimeAdvanced SureScan MRI is part of the first pain neurostimulation system that allows patients safe* access to MRI scans anywhere on the body. SureScan Systems provide long-lasting chronic pain treatment with the confidence of knowing that patients can also get optimal diagnostic treatment whenever the need arises.

    MRI Eligibility

    Medtronic offers the first pain neurostimulation system with SureScan® MRI Technology that is FDA-approved and engineered for patients to safely undergo an MRI scan anywhere in the body.*

    Learn how the SureScan System protects against patient injury

    When an MRI is needed for a patient with an implanted pain stimulation system, new programmer software simplifies the identification of implanted system components and MRI-scan eligibility.

    See how to determine MRI eligibility

    MRI Guidelines for spinal cord stimulation

    Advanced Programming Features

    Innovative features help clinicians to quickly shape and steer stimulation for optimized therapy.

    Programming Efficiency
    • TargetStim® quickly shapes and steers neurostimulation along or between leads to help clinicians find the optimal target and enhance setting
    • Automation of multiple programming steps to simplify programming
    Customized Parameters
    • Easy-to-use interface saves time by automatically generating additional groups based on an existing group
    • Patients can find relief on their own by quickly increasing or decreasing all program amplitudes in a group simultaneously (within physician-set limits)
    • Clinicians can identify actual stimulation-use patterns and understand patients' stimulation needs by reviewing objective data for selected activities and postural changes. Day details can be used to review active groups, number of patient adjustments, and stimulation ON periods
    • Patients can easily recognize groups via name or icon and quickly review stimulation parameter settings for all programs in a group
    Advanced Patient Control
    • TargetMyStim® empowers patients to steer their electrode array and helps patients keep therapy on target if pain patterns change.

    *Under specific conditions and requires SureScan implantable neurostimulator and Vectris® SureScan leads. Refer to MRI Guidelines for full list of conditions.

    United States