OPTIMIZER Smart System - Cardiac contractility modulation system

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Dostupné z:

Impulse Dynamics (Australia) Pty Ltd

Trieda:

AIMD

Výrobca:

Impulse Dynamics (USA) Inc 50 Lake Center Suite 100, Marlton, NJ, 08053 United States Of America

Terapeutické oblasti:

47465 - Cardiac contractility modulation system

Terapeutické indikácie:

The OPTIMIZER Smart System delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions. The system consists of Optimizer Smart IPG (10-B411-3-XX), Optimizer Lead Extension Cable (10-J101-3-XX), OMNI II Programmer (with OMNI Smart Software) System Kit (10-A604-3-XX) and Optimizer Mini Charger System (Mini Charger/Wand 13-100-002 and OPTIMIZER Mini charger Kit 10-F202-3-XX). The OPTIMIZER Smart System is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to moderate to severe left ventricular dysfunction despite appropriate medical therapy. The OPTIMIZER Smart System delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

Stav Autorizácia:

A

Dátum Autorizácia:

2018-05-29