Decision Immediately Expands Access to Heart Failure Therapy with National Coverage for More Than 66 Million[1] Patients

MARLTON, N.J., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Impulse Dynamics®, a global medical device company committed to improving the lives of people with heart failure (HF), announced today that the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination (NCD) for CCM® therapy. CCM® therapy for heart failure (HF) patients is one of only five therapies selected for the Transitional Coverage for Emerging Technologies (TCET) pathway in 2025. This determination marks a transformative milestone for HF patients and their providers, validating that CCM® therapy is no longer experimental or investigational.

“Today's decision represents a victory to HF patients and families who deserve timely access to life-changing, innovative therapies that allow patients to live life to the fullest,” said Jason Spees, CEO, Impulse Dynamics®. “We are grateful to CMS and to the American College of Cardiology, the Heart Failure Society of America, and the Heart Rhythm Society for their support and partnership in advancing access. This decision recognizes the evidence-based outcomes of CCM® therapy, with real-world use surpassing more than 12,000 patients to date and opens the pathway to greater care for HF patients.”

“This NCD is a turning point for patients and providers as it eliminates a major barrier to access by ensuring coverage and reimbursement for a significant population of patients,” said Dr. Kenneth Ellenbogen, MD, FHRS, Kimberling Professor of Cardiology at the Virginia Commonwealth University School of Medicine. “This ensures the reimbursement process becomes more straightforward, enabling physicians to confidently offer CCM® therapy to address symptoms and improve quality of life for HF patients.”

“CCM® is an evidence-backed therapy that has already demonstrated meaningful benefits for HF patients,” said Dr. Andrew Sauer, MD, Advanced Heart Failure & Transplant Cardiologist and Co-Director of the Cardiovascular Research and Clinical Scholars Program at Saint Luke's Mid America Heart Institute. “We are pleased to see CMS's support with this determination, which recognizes the potential of CCM® to help a sizable-population of eligible patients who face significant clinical challenges that come with HF.”

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. 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 and approved for commercial use in the United States and countries worldwide. More than 12,000 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.

Contact:
Hilary Schilmbach
Impulse Dynamics
856-642-9933
hschlimbach@impulsedynamics.com

Rohan More
Impulse Dynamics
856-642-9933
rmore@impulsedynamics.com