Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46801 - catheter tunneller single use - the sensight extension tunneller is a device intended to create a subcutaneous path for tunnelling and passing one or two dbs extension to the intended location during implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 60363 - implantable electrical stimulation device management software - software indicated to assist medical professionals in planning stimulation programming for patients receiving medtronic deep brain stimulation (dbs) devices

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the model 37601 activa pc is an implantable, multi-programmable, non-rechargeable device that delivers electrical stimulation through one or two leads implanted in the brain. the neurostimulator is typically implanted in the pectoral region. the device is indicated for stimulation of the ventral intermediate nucleus for patients with disabling essential tremor or parkinsonian tremor, or stimulation of the internal globus pallidus or the subthalamic nucleus for patients with symptoms of parkinson's disease. studies have shown that deep brain stimulation with the medtronic dbs therapy system is effective in controlling essential tremor and symptoms of parkinson's disease that are not adequately controlled with medications. additionally, dbs is effective in controlling dyskinesias and fluctuations associated with medical therapy for parkinson's disease. medtronic dbs therapy for movement disorders is also indicated for stimulation of the internal globus pallidus or the subthalamic nucleus as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalised and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) for individuals 7 years of age and older. the device is also indicated for the treatment of epilepsy; and intended to be used with the reclaim dbs lead kit (model 3391) for the treatment of obsessive compulsive disorder.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the neurostimulator is a quadripolar, multi-program device that delivers stimulation through one lead. the stimulation settings are stored in programs which are specific combinations of pulse width, rate and amplitude. the device is indicated for stimulation of the ventral intermediate nucleus for patients with disabling essential tremor or parkinsonian tremor, or stimulation of the internal globus pallidus or the subthalamic nucleus for patients with symptoms of parkinson's disease. studies have shown that deep brain stimulation with the medtronic dbs therapy system is effective in controlling essential tremor and symptoms of parkinson's disease that are not adequately controlled with medications. additionally, dbs is effective in controlling dyskinesias and fluctuations associated with medical therapy for parkinson's disease. medtronic dbs therapy for movement disorders is also indicated for stimulation of the internal globus pallidus or the subthalamic nucleus as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalised and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) for individuals 7 years of age and older.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the medtronic model b35200 percept? pc neurostimulator with brainsense? is part of an active implantable device system for deep brain stimulation and sensing. the dbs system delivers electrical stimulation to targeted regions of the brain to suppress the symptoms associated with a neurologic disorder treatable by brain stimulation. the percept pc system is an active implantable device system for deep brain stimulation (dbs) and sensing of bioelectric signals in the brain. therapy for movement disorders is indicated for stimulation of the ventral intermediate nucleus (vim) for patients with disabling essential tremor (et) or parkinsonian tremor, or stimulation of the internal globus pallidus (gpi) or the subthalamic nucleus (stn) for patients with symptoms of parkinson's disease (pd). dbs therapy for movement disorders is also indicated for the stimulation of the internal globus pallidus (gpi) or the subthalamic nucleus (stn) as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis) for individuals 7 years and older. bilateral anterior thalamic nucleus (ant) stimulation using the medtronic dbs system for epilepsy is indicated as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications. medtronic dbs therapy is indicated for bilateral stimulation of the anterior limb of the internal capsule, aic, as an adjunct to medications and as an alternative to anterior capsulotomy for the treatment of chronic, severe, treatment-resistant ocd in adult patients who have failed at least three selective serotonin reuptake inhibitors (ssris)

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the neurostimulator is a octapolar, multi-program device that delivers stimulation through one lead. the stimulation settings are stored in programs which are specific combinations of pulse width, rate and amplitude. the device is indicated for stimulation of the ventral intermediate nucleus for patients with disabling essential tremor or parkinsonian tremor, or stimulation of the internal globus pallidus or the subthalamic nucleus for patients with symptoms of parkinson's disease. studies have shown that deep brain stimulation with the medtronic dbs therapy system is effective in controlling essential tremor and symptoms of parkinson's disease that are not adequately controlled with medications. additionally, dbs is effective in controlling dyskinesias and fluctuations associated with medical therapy for parkinson's disease. medtronic dbs therapy for movement disorders is also indicated for stimulation of the internal globus pallidus or the subthalamic nucleus as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalised and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) for individuals 7 years of age and older.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the model 37612 activa rc is an implantable, multiprogrammable, rechargeable device that delivers electrical stimulation through one or two leads implanted in the brain. the neurostimulator is typically implanted in the pectoral region. the device is indicated for stimulation of the ventral intermediate nucleus for patients with disabling essential tremor or parkinsonian tremor, or stimulation of the internal globus pallidus or the subthalamic nucleus for patients with symptoms of parkinson's disease. studies have shown that deep brain stimulation with the medtronic dbs therapy system is effective in controlling essential tremor and symptoms of parkinson's disease that are not adequately controlled with medications. additionally, dbs is effective in controlling dyskinesias and fluctuations associated with medical therapy for parkinson's disease. medtronic dbs therapy for movement disorders is also indicated for stimulation of the internal globus pallidus or the subthalamic nucleus as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalised and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) for individuals 7 years of age and older.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46642 - cranofacial fixation plate, non-biodegradable - the medtronic model b32000 sensight? burr hole device is used with a neurostimulation system for deep brain stimulation (dbs). the device comprises 1 burr hole device, 1 base, 1 centering tool (preattached to the base),2 bone screws (preinserted in the legs of the centering tool), 1 support clip, 1 cover. the kit 32000 includes additional 1 insertion tool (gray and blue; use with nexframe? stereotactic systems),1 insertion tool (clear; use with stereotactic frames), and 1 disposable screwdriver the medtronic model b32000 sensight? burr hole device kit is used as a component of a neurostimulation system for deep brain stimulation (dbs). the burr hole device in kit form is an implanted device intended to cover a 14-mm burr hole on the skull, and anchor a single compatible lead following cranial surgery.