2
2.1
OPTIMIZER Smart Mini Implantable Pulse
Generator
The OPTIMIZER Smart Mini Implantable Pulse Generator (IPG) is
a medical device intended for the treatment of moderate to severe
heart failure. It is typically implanted under the skin in the upper
left or right chest.
Connected to the OPTIMIZER Smart Mini IPG are two (or
optionally three) cardiac leads that your doctor will insert through
a large vein and into the heart during the implantation process.
These leads have electrodes that allow the OPTIMIZER Smart
Mini IPG to monitor the electrical activity of your heart and deliver
special Cardiac Contractility Modulation (CCM) therapy pulses to
the heart at a specific time during each heartbeat.
The primary effect of this CCM therapy is an increase in the
efficiency and strength of each cardiac contraction, with the
intended result being that more blood is pumped out by the heart
with every heartbeat.
The OPTIMIZER Smart Mini IPG is powered by a rechargeable
battery to extend its service life. A charger specifically designed to
recharge the battery of the OPTIMIZER Smart Mini IPG will be
provided to you after your implant surgery.
The expected life of the OPTIMIZER Smart Mini IPG is limited by
the expected service life of its rechargeable battery.
With weekly charging of your OPTIMIZER Smart Mini IPG, the
rechargeable battery inside the OPTIMIZER Smart Mini IPG
should provide you with at least 20 years of service.
Your OPTIMIZER Smart Mini IPG will need to be replaced when
its battery, after being fully recharged, can no longer maintain
enough charge to deliver CCM therapy for an entire week without
becoming severely depleted.
When being evaluated for elective replacement, you will be
instructed to fully charge your OPTIMIZER Smart Mini IPG 7 days
before your scheduled routine checkup. During your checkup,
your doctor may evaluate the charge capacity of the battery in
your OPTIMIZER Smart Mini IPG.
