4 days ago
Impulse Dynamics® Completes Enrollment of Pivotal Trial for CCM-D® HF System and Earns Category 1 CPT Codes for CCM® Therapy
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.
