Vercise Genus™ Deep Brain Stimulation (DBS) System

INDICATION FOR USE: The Boston Scientific Vercise™ PC, Vercise Gevia™, Vercise Genus™ Deep Brain Stimulation Systems are indicated for use in: -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. The Boston Scientific Vercise Deep Brain Stimulation System is indicated for use in: -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. CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, SIDE EFFECTS: The Boston Scientific Deep Brain Stimulation (DBS) Systems or any of its components, are contraindicated for: Diathermy as either a treatment for a medical condition or as part of a surgical procedure, Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) as the safety of these therapies in patients implanted with the Boston Scientific DBS System has not been established, patients who are unable to operate the system, patients who are poor surgical candidates or who experience unsuccessful test stimulation. Patients implanted with Boston Scientific DBS System without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Patients implanted with 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. Assess patients for the risks of depression and suicide. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy. Monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control and manage appropriately. Refer to the Instructions for Use provided with the Boston Scientific DBS Systems or BostonScientific.com for potential adverse effects, warnings, and precautions prior to using this product. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.