Vercise Gevia™ Dbs System Description; Intended Use / Indications For Use; Essential Performance; Telemetry Information - Boston Scientific Vercise Gevia Instrucciones De Uso

Vercise Gevia™ DBS System Description
The Vercise Gevia DBS System includes a rechargeable 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 Gevia 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 using the Vercise Neural Navigator programming software. The battery
must be replenished periodically with a charging device provided in the charging kit.
Note: The Vercise Gevia DBS System was not made with natural latex.

Intended Use / 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 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.

Essential Performance

The essential performance of the system consists of the following:
• Delivery of stimulation
• Wireless data communication via RF telemetry between the Remote Control and
Stimulators
• Wireless charging of the IPG
Note: Wireless data communication and wireless charging may be temporarily interrupted by
electromagnetic disturbances.

Telemetry Information

• Frequency Band: 119 – 131 kHz
• Modulation type: FSK
• Effective Radiated Power: 0.05 mW (-13 dBm) maximum
• Magnetic Field Strength (at 3 m distance): 46 μA/m
Vercise Gevia™ DBS System Description
Vercise Gevia™ Information for Prescribers
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