Impulse Dymanics OPTIMIZER Smart System - The OPTIMIZER SMART SYSTEM: AN OVERVIEW; Description of the OPTIMIZER Smart IPG

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1. THE OPTIMIZER SMART SYSTEM: AN OVERVIEW
The OPTIMIZER Smart system is intended for the treatment of moderate to severe heart failure.
The system comprises the following components:
• Programmable OPTIMIZER Smart Implantable Pulse Generator (IPG), Model CCM
X10; port plug, #2 torque wrench for securing the implanted leads
• OMNI Smart Programmer, model OMNI
™
II (with OMNI Smart Software)
• OPTIMIZER Smart Charger, model Mini Charger
• Implantable leads: 2 ventricular leads.
1.1 Description of the OPTIMIZER Smart IPG
The OPTIMIZER Smart Implantable Pulse Generator (IPG) is a programmable device
with an internal battery and telemetry functions. The system is intended to treat heart
failure, a condition wherein the heart muscle does not pump blood as well as it should
resulting in reduced cardiac output. The OPTIMIZER Smart IPG monitors the heart’s
intrinsic activity and delivers cardiac contractility modulation (CCM) signals to cardiac
tissue during the ventricular absolute refractory period, when the cardiac tissue is not
capable of activation, thus rendering the CCM signal as non-excitatory. CCM signal
delivery is synchronized with the detected local electrical activity and is capable of
achieving the desired effect on the tissue, e.g. treating heart failure by increasing the
cardiac output, or increasing the contractility of cardiac muscle.
The above-mentioned programmability of the OPTIMIZER Smart IPG implies that
medical personnel can tailor the operating parameters to each patient’s individual
requirements with the OMNI Smart Programmer. The OPTIMIZER Smart IPG is
powered by a rechargeable battery (see Section 1.4), which can be recharged
transcutaneously by inductive power transfer with the OPTIMIZER Mini Charger (see
Section 33.3).
The OPTIMIZER Smart IPG and the OMNI Smart Programmer communicate via
telemetry (for details, see Appendix III). Telemetry is used for IPG programming as well
as for obtaining diagnostic data by device interrogation. The programmer records device
data, maintains a system log, stores standard programs for later use, provides an option to
program “safe” parameters in an emergency, etc.
The OPTIMIZER Smart IPG is connected to two (2) leads that are implanted in the right
ventricle. The OPTIMIZER Smart IPG is compatible with standard pacemaker leads
equipped with IS-1 connectors.