U.S. Post-Approval Study Results Presented at Heart Failure Society of America Annual Meeting<\/p>\n<\/h2>\n\nMARLTON, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) — Impulse Dynamics\u00ae<\/sup>, 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\u00ae<\/sup>\u00a0Therapy 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\u00ae<\/sup> Therapy. This analysis included 530 participants across 71 sites.\u00a0<\/p>\nThe findings add to a growing body of clinical and research evidence for supporting the use of CCM\u00ae<\/sup>Therapy and demonstrate meaningful improvements across multiple HF measures, including heart failure hospitalization, biomarkers, medication utilization, functional status and quality of life.<\/p>\nEvidence at one year showed:<\/p>\n
\n- 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.<\/li>\n
- 97% of patients had improved\/stabilized NYHA functional class at 1-year. 68.1% improved by >=1 class<\/li>\n
- >35% of patients receiving diuretics at baseline discontinued\/decreased diuretic therapy*<\/li>\n
- 18.5 % decrease in NT-proBNP in patients with elevated baseline, a key biomarker of HF*<\/li>\n
- 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<\/li>\n<\/ul>\n
\u201cFor patients living with heart failure, reducing hospitalizations and maintaining or improving functional status and quality of life is a meaningful clinical goal,\u201d 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. \u201cAs 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\u00ae<\/sup> Therapy continued to deliver meaningful and sustained improvements in functional capacity, symptoms and clinical outcomes.\u201d<\/p>\n\u201cThese real-world results continue to reinforce the clinical value of CCM\u00ae<\/sup>\u00a0Therapy across multiple dimensions that matter to patients and physicians,\u201d said Jason Spees, Chief Executive Officer of Impulse Dynamics. \u201cWith more than 60 million people living with heart failure worldwide, these data provide a comprehensive view of the benefits CCM\u00ae<\/sup> Therapy can offer patients who remain symptomatic despite guideline-directed medical therapy.\u201d<\/p>\nAdvances in CCM\u00ae<\/sup>\u00a0Therapy<\/b><\/p>\nImpulse Dynamics remains committed to advancing the science and clinical application of CCM\u00ae<\/sup>\u00a0Therapy. In addition to generating robust, real-world evidence, the company is investing in the next generation of its proprietary CCM\u00ae<\/sup> Therapy platform through innovative clinical programs, including the INTEGRA-D\u2122 and AIM HIGHer trials.\u00a0<\/p>\nThe INTEGRA-D\u2122 trial is a multicenter study evaluating the investigational CCM-D\u00ae<\/sup> HF System**. The investigational device combines two therapies into a single device: CCM\u00ae<\/sup>\u00a0Therapy 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 CCM\u00ae<\/sup>Therapy in patients with symptomatic heart failure and a left ventricular ejection fraction ranging from forty to seventy percent.<\/p>\nAbout the Optimizer\u00ae<\/sup>\u00a0System and CCM\u00ae<\/sup>\u00a0Therapy\u00a0\u00a0<\/b><\/p>\nThe Optimizer\u00ae<\/sup>\u00a0System delivers CCM\u00ae<\/sup>\u00a0Therapy \u2014 the company\u2019s proprietary technology \u2014 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\u00ae<\/sup>\u00a0Therapy 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\u00ae<\/sup> Therapy under the Transitional Coverage for Emerging Technologies (TCET) pathway, reducing an important access and reimbursement barrier for eligible patients in the United States.<\/p>\nCCM\u00ae<\/sup>\u00a0Therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM\u00ae<\/sup> 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.\u00a0<\/p>\nAbout Impulse Dynamics\u00ae\u00a0<\/sup><\/b><\/p>\nImpulse Dynamics\u00ae<\/sup>\u00a0is dedicated to advancing the treatment of heart failure for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM\u00ae<\/sup> Therapy, which is approved for commercial use in the United States and countries worldwide.\u00a0<\/p>\n*Research endpoint not reviewed or approved by FDA.\u00a0<\/em><\/p>\n** The CCM-D\u00ae HF System is currently under review by FDA and is not yet approved for sale in the U.S.<\/em><\/p>\n![]()
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<\/div>\n
\nMelissa Braithwaite<\/p> Impulse Dynamics<\/p>
856-642-9933<\/p>
mbraithwaite@impulsedynamics.com<\/p>
Rohan More<\/p>
Impulse Dynamics<\/p>
856-642-9933<\/p>
rmore@impulsedynamics.com<\/p>
<\/pre>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
Impulse Dynamics\u00ae Presented Real-World, Late-Breaking Data Revealing Heart Failure Hospitalization Reduction and Sustained Clinical Benefits of CCM\u00ae Therapy at One Year U.S. Post-Approval Study Results Presented at Heart Failure Society […]<\/p>\n","protected":false},"author":198164071,"featured_media":48434,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_wpcom_ai_launchpad_first_post":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[125518],"tags":[],"class_list":["post-250165","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globenewswire-en"],"acf":[],"yoast_head":"\n
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MARLTON, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) — Impulse Dynamics\u00ae<\/sup>, 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\u00ae<\/sup>\u00a0Therapy 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\u00ae<\/sup> Therapy. This analysis included 530 participants across 71 sites.\u00a0<\/p>\n The findings add to a growing body of clinical and research evidence for supporting the use of CCM\u00ae<\/sup>Therapy and demonstrate meaningful improvements across multiple HF measures, including heart failure hospitalization, biomarkers, medication utilization, functional status and quality of life.<\/p>\n Evidence at one year showed:<\/p>\n \u201cFor patients living with heart failure, reducing hospitalizations and maintaining or improving functional status and quality of life is a meaningful clinical goal,\u201d 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. \u201cAs 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\u00ae<\/sup> Therapy continued to deliver meaningful and sustained improvements in functional capacity, symptoms and clinical outcomes.\u201d<\/p>\n \u201cThese real-world results continue to reinforce the clinical value of CCM\u00ae<\/sup>\u00a0Therapy across multiple dimensions that matter to patients and physicians,\u201d said Jason Spees, Chief Executive Officer of Impulse Dynamics. \u201cWith more than 60 million people living with heart failure worldwide, these data provide a comprehensive view of the benefits CCM\u00ae<\/sup> Therapy can offer patients who remain symptomatic despite guideline-directed medical therapy.\u201d<\/p>\n Advances in CCM\u00ae<\/sup>\u00a0Therapy<\/b><\/p>\n Impulse Dynamics remains committed to advancing the science and clinical application of CCM\u00ae<\/sup>\u00a0Therapy. In addition to generating robust, real-world evidence, the company is investing in the next generation of its proprietary CCM\u00ae<\/sup> Therapy platform through innovative clinical programs, including the INTEGRA-D\u2122 and AIM HIGHer trials.\u00a0<\/p>\n The INTEGRA-D\u2122 trial is a multicenter study evaluating the investigational CCM-D\u00ae<\/sup> HF System**. The investigational device combines two therapies into a single device: CCM\u00ae<\/sup>\u00a0Therapy 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 CCM\u00ae<\/sup>Therapy in patients with symptomatic heart failure and a left ventricular ejection fraction ranging from forty to seventy percent.<\/p>\n About the Optimizer\u00ae<\/sup>\u00a0System and CCM\u00ae<\/sup>\u00a0Therapy\u00a0\u00a0<\/b><\/p>\n The Optimizer\u00ae<\/sup>\u00a0System delivers CCM\u00ae<\/sup>\u00a0Therapy \u2014 the company\u2019s proprietary technology \u2014 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\u00ae<\/sup>\u00a0Therapy 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\u00ae<\/sup> Therapy under the Transitional Coverage for Emerging Technologies (TCET) pathway, reducing an important access and reimbursement barrier for eligible patients in the United States.<\/p>\n CCM\u00ae<\/sup>\u00a0Therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM\u00ae<\/sup> 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.\u00a0<\/p>\n About Impulse Dynamics\u00ae\u00a0<\/sup><\/b><\/p>\n Impulse Dynamics\u00ae<\/sup>\u00a0is dedicated to advancing the treatment of heart failure for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM\u00ae<\/sup> Therapy, which is approved for commercial use in the United States and countries worldwide.\u00a0<\/p>\n *Research endpoint not reviewed or approved by FDA.\u00a0<\/em><\/p>\n ** The CCM-D\u00ae HF System is currently under review by FDA and is not yet approved for sale in the U.S.<\/em><\/p>\n Impulse Dynamics<\/p> 856-642-9933<\/p> mbraithwaite@impulsedynamics.com<\/p> Rohan More<\/p> Impulse Dynamics<\/p> 856-642-9933<\/p> rmore@impulsedynamics.com<\/p> <\/pre>\n<\/div>\n","protected":false},"excerpt":{"rendered":" Impulse Dynamics\u00ae Presented Real-World, Late-Breaking Data Revealing Heart Failure Hospitalization Reduction and Sustained Clinical Benefits of CCM\u00ae Therapy at One Year U.S. Post-Approval Study Results Presented at Heart Failure Society […]<\/p>\n","protected":false},"author":198164071,"featured_media":48434,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_wpcom_ai_launchpad_first_post":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[125518],"tags":[],"class_list":["post-250165","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globenewswire-en"],"acf":[],"yoast_head":"\n\n
<\/div>\n
Melissa Braithwaite<\/p>