VNS Therapy Aspire SR Pulse Generator Model 106 - Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

LivaNova Australia Pty Ltd

Class:

AIMD

Manufactured by:

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

Therapeutic area:

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

Therapeutic indications:

The VNS Therapy 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 VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications. For the purpose of identifying potential patients who may benefit from using the AutoStim feature of the Model 106 generator, ictal tachycardia shall be defined as an increase in heart rate during a seizure, specifically from a baseline heart rate to a rate that is greater than 100 bpm and is at least a 55% increase or 35 bpm increase from baseline. AutoStim produces stimulation similar in intent to the on-demand stimulation provided by the Magnet Mode. If AutoStim is enabled, stimulation is initiated automatically upon detection of a physiologic signal indicative of the onset of a seizure for some patients. The sensitivity of the detection can be adjusted.

Authorization status:

A

Authorization date:

2016-05-09