The Germany-based Impulse Dynamics just announced that China’s CFDA has approved its Optimizer® system for treatment of chronic heart failure. Impulse Dynamics’ CEO, Dr. Simos Kedikoglou noted “this is a major milestone for Impulse Dynamics, as it will help us offer Cardiac Contractility Modulation therapy to many patients in China who are in need of heart failure symptom relief. It is also indicative of the efforts and investments the company has made in China, as we are one of the very few private companies that have reached such an achievement in-house, reflecting the dedication and commitment of the company’s employees globally.”
The Optimizer® has been successfully implanted in over 3,500 patients worldwide to date, and Cardiac Contractility Modulation technology is already approved for sale in Europe, Australia, Brazil, India, New Zealand and Hong Kong. The implantable Optimizer device delivers non-excitatory Cardiac Contractility Modulation signals to the heart muscle, and initiates multiple biochemical and neurohormonal changes to the myocardium. As a result, the contractility of the myocardium increases with no concomitant increase in oxygen consumption, enabling the heart to operate more efficiently.
According to the announcement, Impulse Dynamics mentioned its commitment in developing its operations in China and making Cardiac Contractility Modulation and the Optimizer® available to Chinese heart failure patients with the approved indication. The company plans to start commercial sales in China in due course.