VNS Therapy SenTiva Generator M1000 - Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
28-05-2020
Send request.
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 pulse generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The VNS SenTiva Generator Model 1000 is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications.
Authorization status:
A
Authorization date:
2020-05-05
