rsRolesWithAccess DOES NOT exist
InDevEnvironment=false
rsRolesWithAccess numRows = [0]
IsInternalUser=[false]
InDevEnvironment=[false]
IsSectionSecure=[false]
Authorized=[false]
LMSAccess=[false]
HasNeuroHCP=[false]
UserLoggedIn=[false]
Loading

Spinal Cord Stimulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • RestoreSensor SureScan MRI Neurostimulator

    View all SCS products

    Features and Specifications

    Summary

    RestoreSensor® SureScan® MRI automatically adjusts stimulation to each patient's optimal setting. This technology, called AdaptiveStim®, automatically recognizes and remembers the correlation between a change in body position and the level of stimulation needed. It records the frequency of position changes and provides objective feedback to help clinicians understand the patient’s stimulation needs as they change over time.

    A function of AdaptiveStim called AdaptiveStim Diary provides objective data regarding patient activity. Clinicians can use this data to assess, evaluate, and optimize a patient's neurostimulation experience.

    RestoreSensor 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 RestoreSensor spinal cord stimulation system is appropriate for use for bilateral and complex pain patterns and high energy requirements.

    *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 54 mm (2.1 in)
    Length 54 mm (2.1 in)
    Thickness 9 mm (0.4 in)
    Weight 45 g (1.6 oz)
    Volume 22 cc
    Battery Life 9 years
    Maximum Electrodes 16
    Rate 2-1200 Hz
    Pulse Width 60-1000msec
    Amplitude 0-10.5 V
    Battery Type Rechargeable
    Groups 8
    Programs 16
    Lead Array Options 1-4
    Implant Depth ≤ 1 cm

    Features

    RestoreSensor® SureScan® MRI offers AdaptiveStim® technology that automatically adjusts stimulation to a patient’s optimal setting. It has the highest energy output capabilities on the market.

    RestoreSensor 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.

    RestoreSensor SureScan MRI is a rechargeable device with a 9-year device life.

    Medtronic continues to build spinal cord neurostimulation systems with the highest parameters. Even with the addition of AdaptiveStim, RestoreSensor SureScan MRI offers high performance, with the following parameters:

    • Amplitude of 10.5 V
    • Rate of 1,200 Hz
    • Pulse width up to 1,000 msec
    • Industry-leading power output of 41.7 mA

    Adaptive Stimulation

    AdaptiveStim reduces the need for patients to manually adjust their stimulation parameters when changing positions.

    Using three-axis accelerometer technology similar to what is used in smartphones and gaming devices, AdaptiveStim:

    • Listens and senses when the patient changes position
    • Learns from previous experience and remembers the patient's last comfortable setting while upright (standing or sitting), lying down, or active in an upright position (eg, jogging)
    • Responds by automatically adjusting stimulation to the patient's optimal settings in each position
    • Responds by automatically adjusting stimulation to the patient’s optimal settings in each position

    View details about AdaptiveStim

    Objective Activity Data

    For the first time ever, clinicians can access objective activity data to assess, evaluate, and optimize a patient’s neurostimulation experience. A function of AdaptiveStim called AdaptiveStim Diary:

    • Provides objective data to augment the patient's subjective feedback for more one-to-one personalized medicine
    • Facilitates a more meaningful dialogue about patient activity level for therapy optimization
    • Provides the objective activity data to help patients set and track goals
    • Aggregates data for clinical research

    View details about objective activity data

    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

    View MRI Guidelines for spinal cord stimulation

    Easy Recharge for Patients

    Advanced technology within the RestoreSensor neurostimulation system makes it easy for patients to recharge their neurostimulator. Recharge intervals for RestoreSensor are approximately 2 weeks at medium settings (recharge intervals vary based upon parameter settings).

    Medtronic Patient Recharger Features

    • Powerful auditory and visual feedback makes patient recharge experiences easier
    • Strength of the recharge-signal icon helps patients find the best location over the neurostimulator for the fastest recharge
    • Battery-level icons of the neurostimulator and recharger keep patients informed of how a recharge session is progressing
    • The Medtronic system is safe enough to recharge while patients sleep. The recharging system automatically shuts off when the battery is fully charged, when the system is not communicating, or when the temperature threshold is exceeded
    • Closed loop recharge system continuously monitors recharge and automatically adjusts to optimize the recharge experience
    • Patient can recharge neurostimulator and recharger simultaneously

    9-Year Device Life

    While other manufacturers may state that their batteries have a longevity greater than 9 years, it's important to understand that many other factors and components are involved in determining the overall longevity of an implanted medical device. The result of extensive design and testing involved in manufacturing rechargeable neurostimulators give Medtronic the confidence that our device is reliable for 9 years.

    To achieve this distinction, Medtronic rigorously verified and validated the many components that impact device longevity, not just the battery. The result is a rechargeable neurostimulator that delivers reliable performance over the entire period of predicted service.

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

    United States