Vercise Genus P32 Implantable PULSE GENERATOR KIT - Brain electrical stimulation system, antitremor

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

זמין מ:

Boston Scientific Pty Ltd

סיווג:

AIMD

תוצרת:

Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop, Valencia, CA, 91355 United States Of America

איזור תרפויטי:

37307 - Brain electrical stimulation system, antitremor

סממני תרפויטית:

The Vercise Genus System includes the Primary Cell Vercise Genus Implantable Pulse Generator (IPG, also known as the Vercise Genus Stimulator). The contents of the Vercise Genus Implantable Pulse Generator Kit are: ? Implantable Pulse Generator ? IPG Template ? Port Plug ? Hex Wrench The Vercise Genus 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.

מצב אישור:

A

תאריך אישור:

2021-04-28