Introduction
Physician Manual
91098825-02 1 of 337
Introduction
Overview of Manual
This manual describes the implantation and usage of the Vercise™ Deep Brain
Stimulation (DBS) System. The Vercise DBS System features a Stimulator coupled
with DBS Leads and DBS Extensions. In this manual you will also nd detailed
descriptions of each system component. Additional information about programming
the Vercise DBS System programming can be found in the DBS Programming
Manual.
Intended Use / Indications for Use
The Vercise Deep Brain Stimulation System is indicated for use in the following:
• Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal
globus pallidus (GPi) for levodopa-responsive Parkinson’s disease which is
not adequately controlled with medication.
• Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal
globus pallidus (GPi) for intractable primary and secondary dystonia, for
persons 7 years of age and older.
• Thalamic stimulation for the suppression of tremor not adequately controlled
by medications in patients diagnosed with Essential Tremor or Parkinson’s
disease.
System Description
The Vercise DBS System includes a Stimulator with DBS Leads for unilateral or
bilateral stimulation. There are also DBS Extensions that allow the DBS Leads
mounted in the skull to be extended to reach the Stimulator implanted near the
clavicle.
The rechargeable Vercise DBS System utilizes current steering across eight contacts
per DBS Lead to provide precise positioning of stimulation. The Stimulator is
controlled by a handheld Remote Control, and can be interfaced with a Clinician’s
Programmer using the Bionic Navigator™ Software. Periodically, the Stimulator
battery must be replenished with an RF charging device provided in the Patient DBS
Charging Kit.
Note: This product contains no detectable latex.
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