Optimizer IVs Implantable Pulse Generator (IPG) - Cardiac contractility modulation system pulse generator

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Impulse Dynamics (Australia) Pty Ltd

Class:

AIMD

Manufactured by:

Impulse Dynamics NV Schottegatweg Oost 10 Unit AIK, Curacao, Dutch Caribbean Netherlands

Therapeutic area:

47468 - Cardiac contractility modulation system pulse generator

Therapeutic indications:

A programmable device with internal rechargeable battery and telemetry functions, normally implanted in the right pectoral region. The system monitors the Heart's intrinsic activity and delivers cardiac contractility modulation (CCM) signals during the ventricular absolute refractory period. The Optimizer IVs Implantable Pulse Generator (IPG) is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction despite appropriate medical therapy. The Optimizer IVs IPG delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

Authorization status:

A

Authorization date:

2015-01-19