FDA Clearance for the first ever Cardiac Contractility Modulation Device


 Synchronization of atrial and ventricular contractions along with correcting the underlying heart’s rhythm is the major functions of most cardiac implants including pacemakers and AICDs. In people with heart failure, these devices manage improving the cardiac performance. However, what lacks is the function of improving myocardial contractility of the heart. Taking over this lacking, an implant that actually uses electrical pulses to improve how hard the heart pushes blood through the body has been developed and has recently received clearance from FDA.

The system has been developed by a company in Orangeburg, New York called Impulse Dynamics. The system is named the Optimizer Smart system and delivers Cardiac Contractility Modulation (CCM). This entails sending non-excitatory pulses during the absolute refractory period of the heart cycle, in turn improving the systolic contraction of the heart muscle. The Optimizer Smart system uses a total of three electrode leads that are attached to the heart and is implanted like any other cardiac implant.

Patients that are not candidates for other electrical modulation implants instead have had chronic, moderate-to-severe heart failure can use this system. The benefits include improved quality of life, better walking distance and functional status of patients for whom this therapy is effective. Patients for cardiac resynchronization therapy are not suitable for this device. Instead, patients with normal heart rhythm and status of 25% to 45% of left ventricular ejection fraction are suitable for it. A professor at the Ohio State University Wexner Medical Center, Professor William T. Abraham, MD in his statement said that effective device-based therapy for advanced heart failure patients with mildly to moderately reduced left ventricular ejection fractions that are not eligible for CRT will finally be available in the United States following the FDA approval.

Lives of numerous heart failure patients in the country who did not have access to therapy earlier will improve with the Optimizer System, along with guideline-directed medical therapies. He further regarded the Optimizer system as the real game-changer for many patients

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