Paving the Way for Broader Access and the First Combined CCM®/ICD System
MARLTON, N.J., July 28, 2025 (GLOBE NEWSWIRE) -- Impulse Dynamics®, a global medical device company committed to improving the lives of people with heart failure (HF), announced two major accomplishments, marking an inflection point in the advancement and accessibility of CCM® Therapy.
- The company successfully completed enrollment in the INTEGRA-D Pivotal Trial. This marks a significant milestone in the journey to introduce the CCM-D® HF System, the world's first device combining Impulse Dynamics®' proprietary CCM® therapy for the treatment of HF symptoms with lifesaving, implantable cardioverter defibrillator (ICD) therapy. The trial's initial results, including 100 percent defibrillation success in the efficacy cohort, were presented as a late-breaking clinical trial at Heart Rhythm 2025 and support a forthcoming PMA submission to the FDA. This milestone advances the potential approval of a first-of-its-kind dual therapy that is designed to address both sudden cardiac death and chronic HF symptoms.
- The American Medical Association (AMA) granted Category I Current Procedural Terminology (CPT) codes for CCM® Therapy. This designation confirms the procedure is both widely performed and supported by strong clinical evidence. Sponsored by the American College of Cardiology (ACC) and Heart Rhythm Society (HRS), this coding advancement represents a major breakthrough in reimbursement access, establishing CCM® as a mainstream therapeutic option. It streamlines insurance billing and lays the foundation for widespread adoption and coverage in the U.S. market.
"We are proud to achieve these two pivotal milestones, which signal the growing acceptance of CCM® Therapy as a core component of HF treatment," said Jason Spees, CEO of Impulse Dynamics®. "The progress of the INTEGRA-D trial moves forward our path to seek regulatory approval of this first-of-its-kind, combined therapy for HF patients. Additionally, we appreciate the support of the ACC and HRS on our CPT coding initiative, and the AMA's timely review process that opens the door to broader access for patients and providers."
"Many HF patients are treated with ICDs to protect against sudden death, but most do not treat HF itself. The INTEGRA-D trial is focused on evaluating a new device aimed at bridging this treatment gap by delivering symptom relief for HF patients receiving ICDs," said Niraj Varma, M.D., Ph.D., Professor of Medicine and Director of Cardiac Pacing and Tachyarrhythmia at the Cleveland Clinic, and National Principal Investigator of the INTEGRA-D clinical trial. "Completing enrollment for this trial is an important step towards evaluating this device for patients that could potentially benefit."
Each year, over 100,000 new ICDs are implanted in patients in the United States alone, adding to the estimated 800,000 individuals currently living with these devices (1,2). The CCM-D® HF System represents an important advancement, potentially offering these patients an option to life-saving technology and HF symptom relief. Additionally, the availability of CPT codes has expanded reimbursement pathways for the current Optimizer® device, helping increase access to this therapy for individuals living with heart failure, underscoring the maturation of CCM® therapy from an emerging innovation to a potentially established standard of care for HF patients. Together, these two milestones represent Impulse Dynamics®' unwavering focus on driving meaningful innovation for the millions of patients living with HF.
About the INTEGRA-D Trial
The INTEGRA-D trial is a multicenter, prospective, single-arm study evaluating the safety and efficacy of CCM-D® HF System. This April, the initial defibrillation efficacy (DE) cohort results were presented by Dr. Niraj Varma as a late-breaking clinical trial at the 2025 Heart Rhythm conference in San Diego, which marked the completion of the efficacy phase of the trial. The CCM-D® device successfully converted induced ventricular fibrillation (VF) in 100 percent of the enrolled patients in the DE cohort, meeting the primary efficacy endpoint. Once six months of follow-up is completed, the data will be submitted to the U.S. Food and Drug Administration (FDA) in a Premarket Approval (PMA) application.
About the Optimizer® System and CCM® Therapy
The Optimizer® system delivers CCM® therapy - the company's proprietary technology - to the heart, providing clinically meaningful improvement to quality of life for appropriate HF patients. CCM® therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body[2]. CCM® therapy is indicated to improve six-minute hall walk, quality of life, and functional status of NYHA Class III HF patients who remain symptomatic despite guideline directed medical therapy, are not receiving CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent. CCM® is the brand name for cardiac contractility modulation - the non-excitatory electrical pulses delivered by the implantable Optimizer® device to improve heart contraction. CCM® therapy sends unique electrical pulses to the heart cells during the absolute refractory period. In doing so, CCM® helps the heart contract more forcibly. Impulse Dynamics® has completed numerous clinical studies, including several randomized controlled trials, the results of which appeared in more than 100 publications in leading medical journals.
About Impulse Dynamics®
Impulse Dynamics® is dedicated to advancing the treatment of 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 shown to be safe and effective for HF patients with debilitating symptoms who otherwise have few effective options available to them. The company is currently engaged in another significant clinical trial called AIM HIGHer. The AIM HIGHer clinical trial is a multicenter study with the objective to evaluate the safety and efficacy of CCM® therapy in patients with symptomatic HF with an ejection fraction of 40 to 70 percent (inclusive). The trial is currently in its initial enrollment phase. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, X (formerly Twitter), and Facebook.
###
References:
- Robert G. Hauser, The Growing Mismatch Between Patient Longevity and the Service Life of Implantable Cardioverter-Defibrillators, Journal of the American College of Cardiology, Volume 45, Issue 12, 2005,
- Khanra D, Manivannan S, Mukherjee A, et al. Incidence and Predictors of Implantable Cardioverter-defibrillator Therapies After Generator Replacement-A Pooled Analysis of 31,640 Patients' Data. J Innov Card Rhythm Manag. 2022 Dec 15;13(12):5278-5293.
- European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202
Hilary Schilmbach Impulse Dynamics 856-642-9933 hschlimbach@impulsedynamics.com Rohan More Impulse Dynamics 856-642-9933 rmore@impulsedynamics.com
