Vercise Gevia™ Deep Brain Stimulation System
Safety Information
Indications for Use
The Vercise Gevia DBS 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 that is not adequately controlled with medication, for persons 18 years of age
and older.
•
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 that is not adequately controlled by medications in patients
diagnosed with Essential Tremor or Parkinson's disease, for persons 18 years of age and older.
Patient Population
Target groups of patients for DBS therapy are those who have:
•
Parkinson's disease (PD) – levodopa-responsive and not adequately controlled with medication in patients 18 years of
age and older
•
Dystonia – primary or secondary intractable dystonia in patients 7 years of age and older
•
Tremor – in PD or essential tremor (ET) inadequately controlled by medication in patients 18 years of age and older
Information for Patients
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