ACTIVA PC 37601 - 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 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.

Statutul autorizaţiei:

A

Data de autorizare:

2022-07-14