Experience Continues to Show CCM Therapy Addresses Clinical Need in Treating Heart Failure
MARLTON, N.J., November 16, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure, announced the 100th implant in China, signifying the opportunity for its innovative Optimizer® system delivering CCM® therapy in markets around the world. Cardiologist Prof. Guo Tao, Executive Director of Internal Medicine, Fuwai Cardiovascular Hospital, Yunnan Province, performed the 100th procedure and emphasized the role of this therapy in providing an option and hope to patients living with the debilitating reality of heart failure.
“It is quite a coincidental milestone for us that the 10th patient implanted in our center also happened to be the 100th patient treated in China. I have paid very close attention to CCM therapy for more than 20 years now, but it wasn’t until recently we could clinically apply this technology. Under close clinical observation, our 10 CCM patients have improved even more than we anticipated. All the CCM patients in our center improved both symptomatically and on various objective indicators, which made both us and our patients very happy. Therefore, it seems from our experience that CCM is performing exactly as described in the foreign research — specifically, by modulating the exchange of calcium ions and thereby enhancing contractility of the myocardium in the acute period, then normalizing the expression of contraction-related proteins, which leads to reverse remodeling of the heart. Based on these results, we are now planning to expand the application of CCM normatively and actively while continuing to closely follow our implanted patients to obtain more clinical evidence of CCM to optimize its application so more Chinese patients can benefit from this latest innovative treatment.”
Prof. Zhang Shu, Chief Physician of Fuwai Hospital of the National Center for Cardiovascular Diseases and the Chinese Academy of Medical Sciences, Honorary Chairman of the Electrocardiology and Pacing Branch of the Chinese Medical Association, Director of the Cardiology Committee of the Chinese Medical Doctor Association, and former President of the Asia-Pacific Heart Rhythm Society further commented “Currently there are almost nine million patients with heart failure in China, and many of them have not been optimally treated. Heart failure has also become the leading cause of death among cardiovascular and other major chronic diseases in China. I believe CCM will bring good news to Chinese patients. These successful initial experiences provide our doctors with good prospects of bringing hope to the patients they care for.”
“We are proud to see the growing acceptance of this technology in markets around the world,” said Mateusz Zelewski, MD, Impulse Dynamics´ VP International. “In reaching this milestone, we have connected with physicians, patients, and their families. We are inspired by the benefits of this therapy to our patients and continue to reinforce our commitment to address the immense need for advanced heart failure options for patients around the world.”
CCM therapy was approved in China late last year, and the first implant in the country was announced on November 1, 2021. The Optimizer system delivers CCM therapy, which consists of electric pulses applied to the heart between heartbeats and serves to enhance the performance of cardiac muscular contraction, making the heart work more efficiently without increasing the heart rate or the oxygen consumption of the cardiac muscle.
To date, CCM therapy has been used to treat heart failure in more than 7,000 patients worldwide and is available in 44 countries across the globe. The therapy has been studied in almost 2,000 patients and has appeared in more than 100 peer-reviewed journal articles. Ongoing studies are also underway to examine the safety and efficacy of CCM for patients suffering from heart failure with a left ventricular ejection fraction between 40 – 60 percent.
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.
Forward-looking Statements
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
www.impulse‐dynamics.com
PUBLIC RELATIONS:
Ian Segal
Manager, Public Relations
Impulse Dynamics
isegal@impulsedynamics.com
856-642-9933
MARKETING OPERATIONS:
Rohan More
Global Vice President, Marketing
Impulse Dynamics
rmore@impulsedynamics.com
856-642-9933
