The Cardiac Contractility Modulation (CCM) Therapy Optimizer® Device is considered investigational and experimental. As an unproven therapy, the Optimizer is NOT considered medically necessary for the treatment of congestive heart failure.

Definitions:

Cardiac Contractility Modulation (CCM)

- CCM is a novel therapy in which the patient’s cardiac muscle is electrically stimulated during the absolute refractory period. Unlike other implantable systems such as pacemakers, the CCM therapy modulates the heart muscle strength without affecting heartbeat or action potential distribution. The electrical impulses trigger physiological processes in the heart’s muscular cells, which create an impact on the cellular function at the molecular level and improve heart function. The therapy is intended to enhance the patient’s physical ability and wellbeing.

CHF- Congestive Heart Failure

Description:

The Optimizer® smart system is a first-of-its-kind, implantable cardiac contractility modulation (CCM) therapy delivery device developed by Impulse Dynamics. It is the first-approved CCM device for the treatment of moderate to severe chronic heart failure in patients, who are at risk despite medical treatment. The device received a breakthrough device designation from the US Food and Drug Administration (FDA) in 2015. The FDA provided clearance for its clinical use in March 2019. The first patient was implanted with the device at the Ohio State University Wexner Medical Centre in May 2019.

The Optimizer device is implanted in the pectoral region on the right side of the patient at a maximum depth of 4cm and connected to two conventional pacemaker leads positioned on the ventricular septum at a distance of around 2cm. The leads are attached to the right ventricle through veins, with one tracking ventricular activity and the other tracking atrial activity. The leads deliver electric CCM signals to the heart’s right ventricle at regular intervals throughout the day.