CCM is a unique and innovative method for treating patients with moderate-to-severe Chronic Heart Failure (CHF) that are symptomatic despite optimal medical therapy. The signals are unique electrical pulses delivered by the Optimizer Smart implantable device during a special period of the heart cycle (the absolute refractory period or the period just after the heart’s excitation). Research has shown that Cardiac Contractility Modulation signals significantly improve the heart’s contractility by modifying the function and expression of certain proteins in the heart muscle and, through that, the function of the heart. In fact, Cardiac Contractility Modulation is the only treatment that actually trains the heart.
European Clinical trials have shown that chronic Cardiac Contractility Modulation treatment is safe and significantly improves exercise tolerance and quality of life in symptomatic heart failure patients with normal QRS duration.
The Optimizer Smart is a minimally invasive implantable device designed to treat Chronic Heart Failure (CHF) in patients that are symptomatic despite appropriate medical treatment. The device is based on novel Cardiac Contractility Modulation technology, and delivers non-excitatory electric pulses.
The Optimizer Smart Implantable Pulse Generator (IPG) unit senses the heart’s electrical activity and delivers Cardiac Contractility Modulation signals via two electrodes placed in the heart’s right ventricle during the absolute refractory period (just after the heart contracts). The IPG is about the size of a pacemaker IPG. Earlier versions of the Optimizer System, including the Optimizer III and Optimizer IVs have been implanted in more than 3,000 patients over the past ten years.
Optimizer Smart Charger System. Patients can recharge the IPG unit on a weekly basis using a home-based charger system, without supervision. Charging the device assures it has enough energy to provide Cardiac Contractility Modulation for years, minimizing the need for Optimizer battery replacement. The charger includes a display that provides instructions and feedback to the patient about the charging process.
OMNI II Programmer System and Omni SMART Application Software. The portable programmer allows medical personnel to customize the Optimizer signal parameters according to individual patient needs. Dynamic evaluations can be made using the patient’s ECG and marker channels in order to optimize the delivery of Cardiac Contractility Modulation signals.
“Optimizer” is a registered United States trademark of Impulse Dynamics N.V.
The Optimizer implant is a small device similar to a pacemaker. It is typically implanted in the right pectoral region and is connected to two standard pacemaker leads that are threaded through veins into the right ventricle. One optional additional lead may be used to sense atrial activity. The other two are used to sense ventricular activity and deliver Cardiac Contractility Modulation signals. The electrodes in the right ventricle are placed on the ventricular septum (the wall separating the heart’s right and left sides) at least 2 cm apart. In contrast to a pacemaker or a defibrillator, the system is designed to modulate the strength of contraction of the heart muscle rather than the rhythm. Cardiac Contractility Modulation therapy is delivered at regular intervals throughout the day.
Recharging of the device is easily performed using a home-based charger system. The charger should be used on a weekly basis and charging sessions typically last about 40 – 60 minutes.