VNS Therapy Demipulse Duo Model 104 Generator - Stimulator, electrical, vagus nerve, antiseizure

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

LivaNova Australia Pty Ltd

Klass:

AIMD

Tillverkad av:

LivaNova USA Inc 100 Cyberonics Blvd, Houston, TX, 77058 United States Of America

Terapiområde:

34210 - Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system

Terapeutiska indikationer:

The Pulse Generator is an implantable, multiprogrammable pulse generator that delivers electrical signals to the vagus nerve. The Pulse Generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the Pulse Generator to the vagus nerve by the Lead. The Lead and the Pulse Generator make up the implantable portion of the VNS Therapy System. The Demipulse Duo Model 104 Generator is compatible with the dual-pin lead. The Vagus Nerve Stimulator therapy system is indicated for the treatment of chronic or recurrent depression in patients that are in a treatment resistant or treatment intolerant major depressive episode and for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures or generalised seizures that are refractory to antiepileptic medications.

Bemyndigande status:

A

Tillstånd datum:

2010-03-12