Activa SC 37603 - Brain electrical stimulation system, antitremor

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

Class III

Manufactured by:

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

Therapeutic area:

37307 - Brain electrical stimulation system, antitremor

Therapeutic indications:

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.

Authorization status:

A

Authorization date:

2022-07-13