Marlton, NJ, March 28, 2025 (GLOBE NEWSWIRE) -- Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce that it received European CE Mark approval for an expanded indication for the Optimizer® Smart Mini system, which delivers the company’s proprietary CCM® therapy. This new indication now offers millions of patients with diastolic HF a way to alleviate debilitating symptoms, improving their quality of life and reducing hospitalizations related to heart failure. [i]
“This expanded indication addresses an important unmet clinical need for patients with diastolic HF or HF with preserved ejection fraction (HFpEF), as it is now also called,” said Prof. Stefan Anker, MD, of Charité Berlin, Germany. “These patients currently have only a few effective treatment options, therefore, the new development by Impulse Dynamics is most welcome. HF specialists in Europe now have an approved device-based treatment for diastolic HF patients that has been shown to improve quality of life and to reduce their need for HF-related hospitalizations.”
“Impulse Dynamics has established leadership and commitment to significantly changing the treatment options available for HF patients,” said Jason Spees, CEO of Impulse Dynamics. “The expanded indication for CCM therapy in Europe is a reflection of the company’s drive to provide proven treatment solutions for all HF patients.”
HF affects more than 64 million people worldwide and causes symptoms like fatigue, shortness of breath, and swelling that can severely limit daily activities and overall quality of life.[ii] Diastolic HF accounts for almost half of the HF population[iii] and occurs when the heart's ventricles become stiff and unable to relax properly, preventing them from filling with enough blood between beats. These patients have limited treatment options available for managing their symptoms.
In Europe, the OPTIMIZER Smart Mini system is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic and diastolic left ventricular dysfunction despite appropriate medical therapy. CCM therapy, as delivered by the OPTIMIZER system, has been shown to improve the clinical status, functional capacity, and quality of life, and prevent hospital admissions in patients with symptomatic left heart failure in eligible patients.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure (HF) 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 HF patients. CCM therapy is delivered through the Optimizer system, which includes an implantable pulse generator (IPG) implanted in a minimally invasive procedure and approved for commercial use in the United States and countries worldwide. More than 10,000 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, X (formerly 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. 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.
[i] Kuschyk, J., Falk, P., Demming, T., Marx, O., Morley, D., Rao, I., & Burkhoff, D. (2021). Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system. European journal of heart failure, 23(7), 1160-1169.
[ii] Groenewegen, A., Rutten, F. H., Mosterd, A., & Hoes, A. W. (2020). Epidemiology of heart failure. European journal of heart failure, 22(8), 1342-1356.
[iii] Cleland, J. G. F., Swedberg, K., Follath, F., Komajda, M., Cohen-Solal, A., Aguilar, J. C., ... & Mason, J. (2003). The EuroHeart Failure survey programme—a survey on the quality of care among patients with heart failure in Europe: Part 1: patient characteristics and diagnosis. European heart journal, 24(5), 442-463.
Rohan More, VP of Global Marketing Impulse Dynamics 856-642-9933 rmore@impulsedynamics.com
