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

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Mevcut itibaren:

Impulse Dynamics (Australia) Pty Ltd

Sınıf:

AIMD

Tarafından üretildi:

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

Terapötik alanı:

47468 - Cardiac contractility modulation system pulse generator

Terapötik endikasyonlar:

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.

Yetkilendirme durumu:

A

Yetkilendirme tarihi:

2015-01-19