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

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Dostopno od:

Impulse Dynamics (Australia) Pty Ltd

Razred:

AIMD

Izdeluje:

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

Terapevtsko območje:

47468 - Cardiac contractility modulation system pulse generator

Terapevtske indikacije:

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 dovoljenje:

A

Datum dovoljenje:

2015-01-19