2025 | HFSA

Impulse Dynamics®’ INTEGRA-D Trial Completes Efficacy Phase

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MARLTON, N.J., April 28, 2025 (GLOBE NEWSWIRE) — Impulse Dynamics® plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce that it reached an important milestone in the INTEGRA-D clinical trial, successfully completing the efficacy phase of the study. Results were presented by Dr. Niraj Varma as a late-breaking clinical trial at the 2025 Heart Rhythm conference in San Diego, CA. The completion of this milestone represents an important step toward bringing to market a single device, the CCM-D® HF System, which combines Impulse Dynamics®’ proprietary CCM® therapy for the treatment of HF symptoms with implantable cardioverter defibrillator (ICD) therapy.

The CCM-D® device successfully converted induced ventricular fibrillation (VF) in patients in the trial, meeting the primary efficacy endpoint – conversion of induced VF to a normal rhythm at the time of device implantation – in 100 percent of patients enrolled consecutively in the INTEGRA-D trial.

“Most of these patients experience severe heart failure symptoms and a reduced quality of life,” said Nir Uriel, M.D., Director of Advanced Heart Failure and Cardiac Transplantation at New York-Presbyterian, Professor of Cardiology at Columbia University Vagelos College of Physicians and Surgeons, Adjunct Professor of Medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine, and Co-Principal Investigator for the INTEGRA-D trial.“These patients often receive a standard ICD that does not relieve heart failure symptoms. The INTEGRA-D trial aims to evaluate a new type of device – CCM-D®  HF System – designed to address this treatment gap by offering symptom relief for patients with heart failure.”