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.
The pulse generator can be placed under the skin in the upper chest area and connected to three leads implanted in the heart.
Director of the FDA’s Division of Cardiovascular Devices Bram Zuckerman said: “Patients with moderate-to-severe chronic heart failure have limited treatment options.
“The FDA recognised the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market while ensuring it meets our regulatory requirements for safety and effectiveness.”
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The FDA’s approval is based on data from two randomised, multi-centre clinical trials performed in a total of 389 participants suffering from moderate-to-severe heart failure. All subjects were treated with optimal medical therapy and 191 patients also received an Optimizer Smart system implant.
Data showed that the system led to improvements in the distance the patients were able to walk in six-minute walking tests and on standard evaluations measuring heart failure symptoms.
The FDA noted infections, bleeding and dislodgement of the leads implanted in the heart are potential complications linked to the system.
Impulse Dynamics is planning to launch the device in the US in the coming months.