Heart failure treatment company Impulse Dynamics reported on Thursday the receipt of approval from the US Food and Drug Administration for its first-in-class Optimizer Smart System designed to address a significant unmet medical need in heart failure.

Following the US FDA's Breakthrough Device designation in 2015, the Optimizer Smart System was the first breakthrough device to go before the Circulatory System Devices Panel of the US FDA's Medical Devices Advisory Committee and received the 12-0 vote on the benefit-to-risk ratio of the device.

The company said the Optimizer Smart System is the first and only CCM (Cardiac Contractility Modulation) device approved by the US FDA to improve six 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.

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.

According to the company's CEO Dr Simos Kedikoglou, Optimizer Smart System will be launched in the US later this year.