U.S. Post-Approval Study Results Presented at Heart Failure Society of America Annual Meeting
MARLTON, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced late-breaking, one-year clinical outcomes from its U.S. Post-Approval Study of CCM Therapy presented at the Heart Failure Society of America (HFSA) 2026 Annual Scientific Meeting. The Post-Approval Study was a prospective, multicenter, long-term observational study approved by the FDA to evaluate long-term safety and clinical outcomes of CCM Therapy. This analysis included 530 participants across 71 sites.
The findings add to a growing body of clinical and research evidence for supporting the use of CCMTherapy and demonstrate meaningful improvements across multiple HF measures, including heart failure hospitalization, biomarkers, medication utilization, functional status and quality of life.
Evidence at one year showed:
- 34% reduction in heart failure hospitalization at 1-year post-implant in patients already optimized on GDMT*. Patients were followed pre vs post-implant 1-year in each direction.
- 97% of patients had improved/stabilized NYHA functional class at 1-year. 68.1% improved by >=1 class
- >35% of patients receiving diuretics at baseline discontinued/decreased diuretic therapy*
- 18.5 % decrease in NT-proBNP in patients with elevated baseline, a key biomarker of HF*
- 70% of patients achieved at least a 5-point improvement (the minimal clinically meaningful threshold) in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
"For patients living with heart failure, reducing hospitalizations and maintaining or improving functional status and quality of life is a meaningful clinical goal," said Rami Kahwash, MD, Heart Failure Cardiologist and Professor of Medicine at The Ohio State University Wexner Medical Center. Dr. Kahwash, the National Principal Investigator of the Post-Approval Study, presented the data at the HFSA late-breaker. "As newer medications continue to reshape the real-world treatment landscape, a large proportion of these patients were receiving ARNi and SGLT2i therapies, which are known to dramatically decrease risk. Despite this, CCM Therapy continued to deliver meaningful and sustained improvements in functional capacity, symptoms and clinical outcomes."
"These real-world results continue to reinforce the clinical value of CCM Therapy across multiple dimensions that matter to patients and physicians," said Jason Spees, Chief Executive Officer of Impulse Dynamics. "With more than 60 million people living with heart failure worldwide, these data provide a comprehensive view of the benefits CCM Therapy can offer patients who remain symptomatic despite guideline-directed medical therapy."
Advances in CCM Therapy
Impulse Dynamics remains committed to advancing the science and clinical application of CCM Therapy. In addition to generating robust, real-world evidence, the company is investing in the next generation of its proprietary CCM Therapy platform through innovative clinical programs, including the INTEGRA-D and AIM HIGHer trials.
The INTEGRA-D trial is a multicenter study evaluating the investigational CCM-D HF System**. The investigational device combines two therapies into a single device: CCM Therapy to potentially improve HF symptoms and implantable cardioverter-defibrillator (ICD) therapy to protect against life-threatening arrhythmias. The AIM HIGHer clinical trial is a multicenter study evaluating the safety and efficacy of CCMTherapy in patients with symptomatic heart failure and a left ventricular ejection fraction ranging from forty to seventy percent.
About the Optimizer System and CCM Therapy
The Optimizer System delivers CCM Therapy - the company's proprietary technology - to the heart, providing an important treatment option for the millions of patients suffering from heart failure. More than 12,000 patients have received CCM Therapy in clinical studies and real-world use. Data from clinical studies, including randomized controlled trials, have been shared in more than 100 publications. In 2025, the Centers for Medicare & Medicaid Services issued a National Coverage Determination for CCM Therapy under the Transitional Coverage for Emerging Technologies (TCET) pathway, reducing an important access and reimbursement barrier for eligible patients in the United States.
CCM Therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. 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.
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 is approved for commercial use in the United States and countries worldwide.
*Research endpoint not reviewed or approved by FDA.
** The CCM-D HF System is currently under review by FDA and is not yet approved for sale in the U.S.
Melissa Braithwaite Impulse Dynamics 856-642-9933 mbraithwaite@impulsedynamics.com Rohan More Impulse Dynamics 856-642-9933 rmore@impulsedynamics.com
