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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 find 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 treatment of 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 treatment of 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.
Introduction
Vercise™ DBS Physician Manual
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