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Indications for Use: The Boston Scientific Vercise™ PC, Vercise Gevia™, Vercise Genus™ Deep Brain Stimulation (DBS) Systems are indicated for use in the following:
• Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
• Bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
• Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.
• 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.
Intended Use:
The Boston Scientific Deep Brain Stimulation (DBS) Systems are intended to treat movement disorders by stimulating a specific brain target.
The Vercise™ DBS Controller is intended to communicate with and control the compatible Boston Scientific Stimulator.
The Charger is a medical device that is intended to charge the battery of the compatible Boston Scientific rechargeable Stimulator.
Contraindications: The Boston Scientific Deep Brain Stimulation (DBS) Systems are not recommended for patients who will be exposed to the following procedures: Diathermy as either a treatment for a medical condition or as part of a surgical procedure, Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS). The safety of these therapies in patients implanted with the Boston Scientific DBS System has not been established. Patients implanted with Boston Scientific DBS Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Patients implanted with the Vercise Gevia or Vercise Genus or Vercise Genus Mixed System with M8 Adapter or Vercise DBS Lead-Only System (before Stimulator is implanted) with ImageReady MRI Technology are Full Body MR Conditional only when exposed to the MRI environment under the specific conditions defined in ImageReady MRI Guidelines for Boston Scientific DBS Systems. The external/non-implantable components of the Vercise Genus DBS System (Charging System, Remote Control, mobile device with Vercise DBS Controller, and accessories) are MR Unsafe. Do not take them into any MRI environment. Boston Scientific DBS Systems are not recommended for patients who are unable to operate the system or are poor surgical candidates or who experience unsuccessful test stimulation.
Warnings: With all medical procedures, there are risks associated with the procedure and the use of the device. Unauthorized modification to the medical devices is prohibited. You should not be exposed to high stimulation levels. High level of stimulation may damage brain tissue. Patients implanted with a Boston Scientific DBS System may be at risk for intracranial hemorrhages (bleeding in the brain) during DBS lead placement. Strong electromagnetic fields, such as power generators, security screeners or theft detection systems, can potentially turn the stimulator off, or cause unpredictable changes in stimulation. The system should not be charged while sleeping. If you notice new onset or worsening depression, changes in mood or behavior or impulse control, or have thoughts of suicide contact your physician or emergency services immediately. You should use caution when doing activities that require coordination, even if you were able to do them before receiving therapy (for example, swimming). Patients should exercise reasonable caution when bathing. Chemical burns may result if the Stimulator housing is ruptured or pierced. The Boston Scientific DBS Systems may interfere with the operation of implanted stimulation devices, such as cardiac pacemakers, implanted cardioverter defibrillators, or medication delivery pumps. Patients should operate motorized vehicles or potentially dangerous machinery with caution. It is unknown whether the DBS device may cause complications with pregnancy. Do not use the Vercise™ DBS Controller while the mobile device is charging. The effect of using the Vercise DBS Controller while charging the mobile device has not been evaluated.
Be sure to talk with your doctor so that you thoroughly understand all of the risks, precautions, and benefits associated with the use of the device and what indicates, and contraindicates, certain patients– as well as the risks and precautions for the procedure. For complete indications for use, contraindications, warnings, precautions, and side effects, see DBSandME.com or call 833-DBS-INFO or 833-327-4636.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
