The CFDA Approves Impulse Dynamics’ Optimizer System for Treatment of Chronic Heart Failure in China
Orangeburg, New York & Stuttgart, Germany. December 18, 2017 – The China Food and Drug Administration (CFDA) has approved Impulse Dynamics’ Optimizer® system for treatment of chronic heart failure. The announcement was made on December 12, 2017 by Impulse Dynamics’ CEO, Dr. Simos Kedikoglou. “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,” said Dr. Kedikoglou.
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. 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.
Dr. Kedikoglou said that Impulse Dynamics is committed to 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.
About the Optimizer and CCM Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart’s cardiac cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 4,000 patients and is currently available in the US, Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and the results have been published in over 80 articles appearing in leading medical journals.
About Impulse Dynamics
Impulse Dynamics is a medical device company dedicated to transforming the treatment of chronic heart failure. With global headquarters in Mount Laurel, N.J., the company has additional offices in; Stuttgart, Germany, Orangeburg, N.Y. and Curacao For more information please visit www.impulse-dynamics.com.
Impulse Dynamics (USA), Inc.
523 Fellowship Road, Suite 203
Mt. Laurel, NJ 08054