Impulse Dynamics’ Pivotal Trial of CCM-D System Completes Enrollment

July 28, 2025—Impulse Dynamics, a developer of cardiac contractility modulation (CCM) technology to treat heart failure (HF), announced completion of enrollment in the INTEGRA-D pivotal trial of its CCM-D HF system.

According to the company, the multicenter, prospective, single-arm study is evaluating the safety and efficacy of the CCM-D HF system, which combines Impulse Dynamics’ CCM therapy for the treatment of HF symptoms with implantable cardioverter defibrillator (ICD) therapy. The dual therapy of the CCM-D HF system is designed to address both sudden cardiac death and chronic HF symptoms, noted the company.

Impulse Dynamics’ CCM therapy delivers nonexcitatory electrical pulses via the company’s implantable Optimizer device to improve heart contraction. The Optimizer, which includes an implantable pulse generator that is placed in a minimally invasive procedure, is approved for commercial use in the United States and countries worldwide, noted the press release.

Impulse Dynamics stated that the INTEGRA-D trial’s initial results, including 100% defibrillation success in the efficacy cohort, were presented at Heart Rhythm 2025 and support a forthcoming premarket approval submission to the FDA to be made when 6-month follow-up is complete.

Niraj Varma, MD, who serves as National Principal Investigator of the INTEGRA-D clinical trial, discussed the enrollment milestone in the company’s press release.

“Many HF patients are treated with ICDs to protect against sudden death, but most do not treat HF itself,” commented Dr. Varma. “The INTEGRA-D trial is focused on evaluating a new device aimed at bridging this treatment gap by delivering symptom relief for HF patients receiving ICDs. Completing enrollment for this trial is an important step towards evaluating this device for patients that could potentially benefit.” Dr. Varma is Professor of Medicine and Director of Cardiac Pacing and Tachyarrhythmia at the Cleveland Clinic in Cleveland, Ohio.

The company also reported that the American Medical Association granted Category I Current Procedural Terminology (CPT) codes for CCM therapy. The designation confirms the procedure is both widely performed and supported by strong clinical evidence, stated the company. The CPT coding, which was sponsored by the American College of Cardiology and Heart Rhythm Society, establishes CCM as a mainstream therapeutic option; streamlines insurance billing; and lays the foundation for wide adoption and coverage in the United States market, noted Impulse Dynamics.