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

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
07-11-2017

Boleh didapati daripada:

Impulse Dynamics (Australia) Pty Ltd

Kelas:

AIMD

Dikeluarkan oleh:

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

Kawasan terapeutik:

47468 - Cardiac contractility modulation system pulse generator

Tanda-tanda terapeutik:

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 kebenaran:

A

Tarikh kebenaran:

2015-01-19

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