Device Dossier

Optimizer Mini Charger System - Implant battery charger

Device Dossier for Optimizer Mini Charger System - Implant battery charger (Implant battery charger, Class III, sponsor Impulse Dynamics). ARTG record,…

Intended purpose

The Optimizer Mini Charger System is for recharging the battery located in the Optimizer Implantable Pulse Generator (IPG). The Optimizer IPG System 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 IPG delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

Functional description

The Optimizer Mini Charger is intended to recharge the OPTIMIZER IPG transcutaneously by inductive power transfer and has been designed to permit recharging with minimal patient interaction. The Optimizer Mini Charger System includes the OPTIMIZER Mini charger Kit 10-F202-3-XX and the Mini Charger/Wand 13-100-002. The charger is powered by a rechargeable battery, and the kit is supplied with a AC Adapter to recharge the internal battery.

TGA Public Summary