The Optimizer system developed by Impulse Dynamics has received approval from the China Food and Drug Administration (CFDA). The Optimizer is an implantable cardiac contractility modulation therapy device for chronic heart failure patients. It is the only device therapy available for patients with a narrow QRS complex.
A large percentage of advanced heart failure patients have a normal QRS duration, making them unsuitable for cardiac resynchronisation therapy (CRT) devices. Impulse Dynamics’ Optimizer device delivers nonexcitatory cardiac contractility modulation signals to the heart during the absolute refractory period, initiating multiple biochemical and neurohormonal changes to the myocardium. As a result, the device is intended to increase contractility of the myocardium with no concomitant increase in oxygen consumption, enabling the heart to operate more efficiently.
The Optimizer has been successfully implanted in over 3,500 patients worldwide to date, and cardiac contractility modulation technology is approved for sale in Europe, Australia, Brazil, India, New Zealand and Hong Kong. The device is also referenced in the 2016 European Heart Failure Association guidelines as a potential treatment for heart failure patients.
CEO of Impulse Dynamics, Simos Kedikoglou, said that the company is committed to developing its operations in China and making cardiac contractility modulation therapy and the Optimizer available to Chinese heart failure patients with the approved indication. The company is currently in the planning stages of their commercial launch in China.
Cardiac contractility modulation is an innovative therapy designed for patients with a reduced ejection fraction and advanced heart failure. Impulse Dynamics’ Optimizer device has been investigated in clinical studies, including several randomised controlled trials, as published in articles in over 70 medical journals. The device is currently approved in the USA for investigational use only.
The company recently also launched their next generation device in Europe, the Optimizer Smart, after it received its CE mark. The device features a two-lead configuration, making the implantation procedure quicker and easier.