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Sacral Neuromodulation

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  • InterStim II Neurostimulator

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    Features and Specifications

    Summary

    The InterStim® II neurostimulator was developed to offer physicians a second choice of neurostimulators and to address a wider range of patient needs. The InterStim II neurostimulator is 37% smaller by displaced volume and almost 50% lighter by weight (22 g versus 42 g) than the InterStim neurostimulator model 3023. The InterStim II neurostimulator is intended for patients who will benefit from the use of a smaller implanted device, and who experience symptom control with low to moderate neurostimulation parameters.

    The InterStim II neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws.

    MRI Conditionally Safe
    InterStim II model 3058 has FDA-approved labeling for 1.5 Tesla MRI head scans.

    View MRI guidelines for InterStim systems

    Indications and Contraindications

    Product technical manuals must be reviewed prior to use for detailed disclosure.

    Indications

    InterStim® Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

    The following Warning applies only to InterStim Therapy for Urinary Control.

    Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

    InterStim Therapy for Bowel Control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.

    For both InterStim Therapy for Urinary Control and InterStim Therapy for Bowel Control: Select patients carefully to ensure that they meet the following criteria:

     

    • They are appropriate candidates for surgery
    • They can properly operate the system
    • They received satisfactory results from test stimulation

    Contraindications

    Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.

    Specifications

    Physical Specifications
    Height

    44 mm (1.7 in)

    Length

    51 mm (2.0 in)

    Thickness

    7.7 mm (0.3 in)

    Weight

    22 g (0.77 oz)

    Volume

    14 cc

    Battery Capacity

    1.3 amp hours (see table below for battery life estimations)

    Number of Electrodes

    4

    Rate*

    10-14 Hz

    Pulse Width*

    180-240 µsec

    Amplitude

    0-8.5 V**

    Rechargeable

    No

    Cycling*

    OFF/ON: 8 sec to 16 sec

    Compatible Leads

    28 cm, 33 cm, 41 cm

    Number of Screws

    1

    Lead Insertion Indicator

    Integrated into lead

    Strain Relief

    Integrated into header

    Functional Telemetry Area***

    105 cm3

    *These are typical settings.
    **A typical setting for amplitude is based on patient comfort, which is determined during a programming sessions.
    *** At 2.5 cm implant depth

    This section presents selected product specifications. For complete, detailed product information refer to the InterStim and InterStim II Implant Manual and the N'Vision Clinician Programmer Model 8840 and Application Card Model 8870 Programming Guide


    Neurostimulator Battery Life: Estimated battery life at high, moderate, and low energy consumption

    Description Amp (v) Rate (Hz) Pulsewidth (μs) Mode Electrodes Longevity
    (years)
    High energy

    4 v

    14 Hz

    210 μs

    Continuous

    Bipolar, 2 active

    2.9

    Moderate energy

    3 v

    14 Hz

    210 μs

    Cycling: 16 s ON, 8 s OFF

    Bipolar, 2 active

    4.4

    Low energy

    2 v

    10 Hz

    210 μs

    Cycling: 16 s ON, 8 s OFF

    Bipolar, 2 active

    5.4

    †These estimations of battery life assume a new neurostimulator with no subsequent adjustments to stimulation parameters. Battery life will be shortened if stimulation parameters are increased to consume more energy. Accurate placement of the InterStim Therapy lead will minimize stimulation parameters and energy consumption, thus maximizing battery life.

    Features

    In addition to being 37% smaller by volume and almost 50% lighter than the InterStim neurostimulator model 3023, the InterStim II sacral nerve neurostimulator:

    • Connects directly to the lead, eliminating need for an extension
    • Accommodates three lead sizes – 28 cm, 33 cm, and 41 cm
    • Compatible with a lead insertion indicator in the lead
    • Integrates strain relief in the header
    • Incorporates radiopaque identification of the manufacturer and neurostimulator model number
    • Allows 1-screw implantation

    United States