Impulse Dynamics’ Optimizer System gets China FDA approval
German medical device firm Impulse Dynamics has secured approval from the China Food and Drug Administration (CFDA) for its Optimizer system to treat chronic heart failure.
Optimizer is an implantable device designed to deliver non-excitatory Cardiac Contractility Modulation signals to the heart muscle.
Cardiac Contractility Modulation is a new therapy indicated for patients suffering from a decreased ejection fraction and advanced heart failure.
The device triggers various biochemical and neurohormonal changes to the myocardium for increasing its contractility to enable efficient operation of heart, without increasing concomitant in oxygen consumption.
Impulse Dynamics CEO Dr Simos Kedikoglou said: “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 firm’s Contractility Modulation technology has secured marketing approval in Europe, Australia, Brazil, India, New Zealand, and Hong Kong.
Optimizer is reported to have been successfully implanted in more than 3,500 patients to date.
The launch of Cardiac Contractility Modulation and the Optimizer in China is part of the firm’s plan to advance its operations in the country.