CCM system for heart failure approved in USMay 8, 2019
Impulse Dynamics has received approval from the US FDA for its Optimizer Smart System for use in heart failure populations.
The Optimizer Smart System is the first and only CCM (Cardiac Contractility Modulation) therapy device approved by the FDA to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, and those patients who are in normal sinus rhythm, are not indicated for cardiac resynchronization therapy (CRT) and have a left ventricle ejection fraction (LVEF) ranging from 25% to 45%.
Only 30 percent of moderate to severe chronic heart failure patients are candidates for CRT, which historically has left 70 percent of patients with few options to help them manage their disease.
CCM is a unique electrical pulse delivered during the absolute refractory period, which is just after the heart contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.
CCM is the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart.