Use Instructions

Over the years of evaluation of cardiac contractility modulation therapy and use of the

therapy outside the USA in countries that accept the CE Mark, CCM was delivered using

various models of the OPTIMIZER System, which includes an implantable pulse generator

(IPG) that is programmable and has a rechargeable battery. In principle, the OPTIMIZER

System is implanted in a procedure which is similar to a pacemaker implantation. Unlike

pacemakers or defibrillators, the OPTIMIZER System does not have integrated pacing or

defibrillation capabilities, and is only used for delivering cardiac contractility modulation

therapy. Often a patient may have concomitant implantable devices, as may be indicated per

patient. The OPTIMIZER is connected to the heart’s ventricles using leads, typically with the

electrodes fixated to the right ventricular septum. For example, the ventricular leads may be

spaced apart by a few centimeters and positioned on the septum, at or adjacent to an

intersection of the septum and right ventricular free wall. The electrodes are used for sensing

electrical activity of the heart and for delivery of CCM signals to the ventricular muscle at the

proper timing and signal configuration. The OPTIMIZER can be programmed to deliver

cardiac contractility modulation therapy for several hours every day: typically 5 hours per day

in the US studies, and 7 or more hours per day in other countries. As part of the OPTIMIZER

algorithm, the circuitry records one or more local electrical activity (i.e. activity in the vicinity of

the electrode measured using the bipolar electrode configuration) or non-local electrical

activity (i.e. wide-field electrogram using unipolar sensing between the electrode and the

distant IPG can). The timing of the CCM delivery is determined to be at a certain delay and

duration from the sensing, designed to deliver the CCM during the absolute refractory period

of the muscle within the current beat cycle; this may maintain the CCM signal non-excitatory.

If the patient has a concomitant pacing or defibrillation device, the OPTIMIZER can be

configured to apply the CCM signals during a paced cardiac cycle, within the refractory period

which follows the pacing. The OPTIMIZER can also be configured to apply the CCM signal

during a non-paced cardiac cycle. The algorithm also applies criteria for delivery of the CCM

signal or inhibiting the delivery of the CCM signal according to the relative timing of events,

for example using criteria for minimum and maximum acceptable heart rate (R-R intervals),

minimum and maximum acceptable time between sensed events in two locations on the RV

septum, inhibition if signals are detected at an unexpected timing, and/or the use of an alert

window in order to detect unexpected events and potentially block CCM delivery. Thus, the

OPTIMIZER may deliver the non-excitatory CCM signal during the absolute refractory period

of hundreds or thousands of beats out of 50,000 consecutive beats, taking into account the

detection of any conditions that inhibit the CCM signal delivery (such as, for example, a

detected arrhythmia). The parameters of the algorithm are configured per patient, with the

purpose of enabling the normal delivery of the contractility modulating signal when the trace

of events is indicative of an expected activation sequence of the heart.