CCM Therapy Addresses an Unmet Clinical Need and Offers Hope to Millions With Heart Failure
MARLTON, N.J., April 26, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce a worldwide milestone achievement as the 7,000th patient has received the Optimizer® Smart for the treatment of moderate HF. Dr. Raul Weiss, Professor of Clinical Medicine and Director of the Electrophysiology Fellowship Program at the Ohio State University Wexner Medical Center in Columbus, Ohio, conducted the implant procedure in less than 45 minutes, underscoring the significant clinical experience that exists for the therapy.
“It’s great to see the breakthrough technology of Optimizer Smart improving the lives of so many patients,” said Dr. Weiss. “I was an early adopter of this technology and was involved in early clinical trials. It is gratifying to see the patients treated and reported in more than 100 publications. Our experiences with CCM have been positive, and as more of my colleagues are now seeing those same positive results, I expect the number of CCM patients to grow even more significantly.”
“We are pleased to have reached yet another milestone in our relentless quest to change the way HF is treated,” said Simos Kedikoglou, MD, CEO of Impulse Dynamics. “While this is certainly an achievement that can be expressed in numbers, what’s most important is what we know to be the impacts CCM has on patients, their families, and their extended communities.”
This milestone is significant because it showcases clinical experience that continues to define and support the utility of this technology in providing hope for patients living with heart failure. In the time since this technology was imagined, it is now available in 44 countries, and the technology has continued to advance based on the needs of patients and physicians. Impulse Dynamics is steeped in a culture that celebrates making patients our top priority. From its very inception, the company has held fast to an important tenet — put patients first, and business will follow.
Dr. Marc Silver, a cardiologist in Chandler, Arizona, and a founding member of the Heart Failure Society of America, expressed the following regarding the critical role of referring providers. “It’s well-known that the large majority of patients with moderate heart failure here in the US, and the millions internationally who may benefit most from CCM therapy, are being cared for by cardiology practitioners in their local communities. Knowing about this treatment option, being able to identify appropriate candidates, and considering it for ones who are indicated adds an important tool to the armamentarium of front-line providers in the fight against heart failure.”
The Optimizer Smart delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve 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 receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.
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 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 receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.
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:
Hilary Schlimbach
Sr. Manager, Marketing Communications
Impulse Dynamics
isegal@impulsedynamics.com
856-642-9933
MARKETING OPERATIONS:
Rohan More
Global Vice President, Marketing
Impulse Dynamics
rmore@impulsedynamics.com
856-642-9933
