Heart failure device Optimizer Smart gets FDA approval

Impulse Dynamics has secured US Food and Drug Administration (FDA) approval for its implantable Optimizer Smart device for the treatment of moderate-to-severe chronic heart failure.

The new system is designed to improve walking distance, quality of life and functional status of patients that are incompatible with other treatments such as cardiac resynchronisation therapy, which coordinates the function of the left and right ventricles.

Consisting of an implantable pulse generator, a battery charger, a programmer and software, Optimizer Smart provides cardiac contractility modulation (CCM) therapy, which delivers electrical pulses during the absolute refractory period of the cardiac cycle to improve systolic contraction.

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source verdictmedicaldevices