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

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Impulse Dynamics (Australia) Pty Ltd

Classe:

AIMD

Fabricado por:

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

Área terapêutica:

47468 - Cardiac contractility modulation system pulse generator

Indicações terapêuticas:

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.

Status de autorização:

A

Data de autorização:

2015-01-19