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Vercise™ Indications, Safety, and Warnings

Deep Brain Simulator Systems

The Vercise™ Deep Brain Stimulation (DBS) Systems are indicated for use in unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of levodopa-responsive Parkinson’s disease which is not adequately controlled with medication and also for treatment of intractable primary and secondary Dystonia, for persons 7 years of age and older. Thalamic stimulation using the Boston Scientific Vercise™ DBS System is indicated for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.

Vercise DBS Lead-only system (before Stimulator is implanted) and the Vercise Gevia™ systems are MR conditional. An MRI examination can be conducted safely when all instructions in the supplemental manual MRI Guidelines for Boston Scientific DBS Systems are followed.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Vercise DBS Systems indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority registrations. Material not intended for use in France.

The Vercise M8 Adaptor is a 1 x 8 in-line connector that is designed to connect specific Medtronic® lead extensions to the Boston Scientific DBS System Stimulator, as part of a deep brain stimulation procedure.

Vercise™ and Vercise Gevia™ are registered trademarks of Boston Scientific Corporation or its affiliates. All cited trademarks are the property of their respective owners.

Products shown for INFORMATION purposes only and may not be approved for sale in certain countries. Please check availability with your local sales representative or customer service.

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