First Optimizer® Smart Device Implanted in China

Mount Laurel, NJ, November 1, 2019 – On October 29, 2019, the first Optimizer Smart Cardiac Contractility Modulation CCMTM device was implanted in China at the Boao Super Hospital. Impulse Dynamics’ Optimizer Smart is one of the world’s most advanced heart failure treatment devices,  which now expands treatment options for patients with chronic heart failure through the special NMPA program  allowing implants in China’s Hainan province while the device application is under review by the NMPA.

The Optimizer Smart System administers Impulse Dynamics’ proprietary CCM therapy, consisting of precisely timed electrical pulses delivered directly to the heart during the absolute refractory period, which occurs just after the heart initially contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength rather than the rhythm of the heart’s contraction. CCM is an effective solution for severe chronic heart failure patients are not candidates for CRT, and is now a device-based option for over 70 percent of heart failure patients who until now had few options to help them manage their progressive disease.

This Optimizer Smart was implanted in a 60-year-old male patient with long-term coronary heart disease who had undergone bypass surgery and coronary stent implantation, was admitted to the local hospital due to severe chest tightness, shortness of breath and dizziness after daily activity and was diagnosed with decreased cardiac function and normal QRS durarion (103ms). Consultation by his expert team suggested that CCM treatment should be applied to improve the symptoms of heart failure and reduce the risk of sudden cardiac death

The Optimizer Smart implant procedure was perfomed by Professor Hua Wei,  Expert of Boao Super Hospital International Heart Center, and Deputy Director of the Center for Arrhythmia at the National Center for Cardiovascular Diseases.  ”Most domestic patients receive drug therapy as treatment for heart failure, but with disease progression, the effect of drug treatment diminishes significantly” said Professor Hua Wei.  “Cardiac resynchronization therapy (CRT) provides a therapy solution only for patients with wide QRS (>130 ms), leaving the approximately 70 percent of patients with normal QRS with few options to help them manage their disease. CCM and the Optimizer Smart provide new hope to these patients and can significantly improve their clinical symptoms and quality of life.”

“There are over 10 million patients with heart failure in China and their five-year mortality rate currently exceeds 50%”  says Proressor Zhang Shu, Chief Expert of Cardiology at Boao Super Hospital, and Chairman of the Cardiology Committee of the Chinese Medical Association and of the National Cardiovascular Disease Center. “We are excited to be able to offer the Optimizer Smart to those patients who currently do not have a device based alternative to improve cardiac function.”

Optimizer Smart is the first FDA designated Breakthrough Device to go before an FDA Advisory Committee where it received a unanimous recommendation for approval based on the panel’s assessment of benefit versus risk. The device then went on to receive the FDA’s PMA approval on March 21, 2019. The device was introduced in Boao, Hainan six months later through the NMPA’s  “Urgent clinical need” program. The Optimizer Smart implantable pulse generator is currently undergoing the registration process with the Chinese NMPA, but physicians are able to implant it thanks to the Lecheng International Medical Tourism Pilot Zone, and the desire to increase cooperation in the field of cardiac medicine in China. This initiative will help better serve patients both domestically and abroad and will boost the development of Hainan’s health industry.

 

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