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® Integra CCM-D™ System and CCM® Therapy
The Optimizer Integra CCM-D System is an investigational device that combines CCM therapy and ICD therapy into one device. This device is being used in an FDA-approved Investigational Device Exemption (IDE) study and is not available for sale in the United States.
Impulse Dynamics currently offers the Optimizer system that is FDA-approved and CE-marked. The Optimizer system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve the 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.
CCM therapy delivers non-excitatory electrical pulses from the implantable Optimizer device in a manner designed to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during their absolute refractory period. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and CCM therapy has been published in more than 120 peer-reviewed journal articles.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM therapy, which uses the Optimizer technology platform to improve quality of life in heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 9,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be safe and effective for heart failure patients with debilitating symptoms who otherwise have few effective options available to them. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, Twitter, and Facebook.
This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning potential benefits of CCM therapy, and CCM therapy combined with an ICD delivered via a single device (CCM-D), and the absence of risks associated therewith; the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer Integra CCM-D System and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release include, without limitation: the company’s future research and development costs, capital requirements and the company’s needs for additional financing; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for Optimizer systems or any future products the company may seek to commercialize; competitive companies and technologies in the industry; the company’s ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the company’s business model and strategic plans for its products, technologies and business, including its implementation thereof; the company’s ability to expand, manage and maintain its direct sales and marketing organization; the company’s ability to commercialize or obtain regulatory approvals for CCM therapy and its products, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; and the company’s ability to establish and maintain intellectual property protection for CCM therapy and products or avoid claims of infringement. The company does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
Impulse Dynamics (USA), Inc.
50 Lake Center Executive Park, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933