Optimizer Smart IPG - Cardiac contractility modulation system pulse generator

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Impulse Dynamics (Australia) Pty Ltd

classe:

AIMD

Fabriqué par:

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

Domaine thérapeutique:

47468 - Cardiac contractility modulation system pulse generator

indications thérapeutiques:

The OPTIMIZER SMART IPG is an implantable device designed for subcutaneous implant in the upper chest. The IPG delivers Cardiac Contractility Modulation (CCM) signals to the heart via two standard pacing leads attached to the right ventricular septum. When delivering CCM therapy, the IPG continuously monitors the heart?s intrinsic activity via two ventricular sense amplifiers, and generates CCM signals in synchrony with the detected local electrical activity. The Optimizer SMART 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 SMART IPG delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

Statut de autorisation:

A

Date de l'autorisation:

2017-08-30