Investigators Report Positive Findings From Feasibility Study of CCM in Heart FailureWith Preserved Ejection Fraction at the European Society of Cardiology Heart Failure 2022 Congress
Patients with HFpEF suffer from debilitating symptoms and have very few therapeutic options. This patient population is a similar size as the one with reduced ejection fraction and has been shown to have similar struggles with quality of life, hospitalizations, and mortality.
Cecilia Linde, MD, Professor and Consultant in Cardiology at the Heart and Vascular Theme of Karolinska University Hospital and the Karolinska Institute in Stockholm, Sweden, who was the co-principal investigator for this investigation, said, “The CCM-HFpEF Pilot Study was conducted to explore the hypothesis that CCM therapy might benefit patients with HFpEF. Our hypothesis was based on evidence of greater benefits in CCM HFrEF studies in those with higher LVEF range and from case reports of HFpEF patients. In our CCM-HFpEF-Pilot Study, we found significant benefits from CCM therapy in patients with preserved LVEF, supporting prior findings. I look forward to following the progress of the recently begun pivotal AIM HIGHer trial to continue this journey further.”
Dr. Ishu Rao, Medical Director for Impulse Dynamics, welcomed these results because they confirm the potential for positive results in the company’s recently initiated AIM HIGHer trial. “We are also excited to announce that enrollment is well underway for this landmark IDE-approved, multicenter, randomized, and blinded pivotal trial designed not only to confirm Dr. Linde’s groundbreaking work presented today but to go further yet by providing the first long term morbidity and mortality results for a modern Optimizer CCM device. While Dr. Linde specifically studied patients with EFs ≥50%, in AIM HIGHer, we are examining the efficacy of CCM therapy in 1,500 patients with EFs between 40% and 60%. This represents a large cohort of patients who currently have minimal treatment options and are clamoring for help. If AIM HIGHer’s results are consistent with Dr. Linde’s findings, we may finally begin to close the significant gap in care that exists for millions of patients afflicted with HF and higher EF.”
HF affects more than 64 million people worldwide and leads to dramatic declines in a patient’s quality of life. Patients are often classified by a measure of cardiac function known as the ejection fraction (EF), which describes the percentage of blood pumped out of the left ventricle with each heartbeat. CCM therapy is currently indicated in Europe for patients that have an EF below 50% and has been proven to reduce hospitalizations. However, HF patients with higher EF have had few therapeutic options thus far to alleviate their symptoms and treat their disease.
The purpose of the AIM HIGHer trial — the largest randomized, sham-controlled, device-based interventional heart failure trial — is to further assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients. CCM therapy for HFpEF has already received the FDA’s breakthrough device designation. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards consistent with the Agency’s mission to protect and promote public health.
The Optimizer Smart Mini delivers CCM therapy which consists of precisely timed electrical pulses sent to the heart. These signals are designed to improve the heart’s ability to function properly, allowing more oxygen-rich blood to be pushed out through the body.
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