Vercise™ PC DBS System Description
The Vercise PC 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 Vercise PC DBS System
utilizes current steering across eight contacts per DBS Lead to provide precise positioning of
stimulation. The Stimulator is controlled by a hand-held Remote Control, and can be interfaced with
a Clinician's Programmer.
The battery of the non-rechargeable stimulator will become depleted. The longevity of the
Stimulator battery depends on the following factors:
•
Programmed parameters
•
System impedance
•
Hours per day of stimulation
•
Changes to stimulation made by the patient
For additional information on estimating the longevity of the non-rechargeable battery, refer to the
appropriate programming manual as listed on your DBS Reference Guide.
Note: The Vercise PC System contains no detectable latex.
Intended Use / Indications for Use
The Vercise PC DBS 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.
Vercise™ PC DBS System Description
Vercise™ PC Information for Prescribers
90985313-04 Rev A 1 of 423