Impulse Dynamics® Celebrates CMS National Coverage Determination for CCM® Therapy

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

Impulse Dynamics Press Release

MARLTON, N.J., October, 29, 2025 — 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.”

1.    https://www.medicare.gov/about-us
2.    European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202

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.