Percept PC BrainSense B35200 - Brain electrical stimulation system, antitremor

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Medtronic Australasia Pty Ltd

Clasă:

Class III

Produs de:

Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America

Zonă Terapeutică:

37307 - Brain electrical stimulation system, antitremor

Indicații terapeutice:

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)

Statutul autorizaţiei:

A

Data de autorizare:

2022-07-14