Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor.

Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinson’s disease.

Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.

Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications.

The neurostimulation system is indicated for the following conditions: The system is intended to be used with leads and associated extensions that are compatible with the system. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures.

For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. Read this section to gather important prescription and safety information. To allow the MRI scanner to estimate the SAR, ensure that you enter the patient’s body weight accurately into the scanner.ĭeep Brain Stimulation (DBS) Therapy Prescription and Safety Information Ensure the scanner displays the SAR parameters prospectively (whole body SAR, head SAR, or both as applicable). NOTE: If the B1+rms display is unavailable on your scanner, then you must maintain the specific absorption rate (SAR) limit. Do not use other transmit coil designs (e.g., linear, phased-array, or saddle) because these have not been tested and could result in serious patient injury. Only quadrature, birdcage RF transmit-receive coil designs have been tested. Exceeding the safe RF power limit could increase the risk of excessive heating of implanted components. In this case, do not manually adjust the scan parameters after the prescan because the implanted system may be exposed to higher-than-expected RF power. Some scanners may not update the displayed RF power when manual adjustments are made after the prescan.

Personnel knowledgeable in MR safety should be involved to optimally plan the scan and actively monitor the RF power level during the scan.

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