We are proud to achieve these two pivotal milestones, which signal the growing acceptance of CCM\u00ae Therapy as a core component of HF treatment, said Jason Spees, CEO of Impulse Dynamics\u00ae.\u00a0\u00a0The progress of the INTEGRA-D trial moves forward our path to seek regulatory approval of this first-of-its-kind, combined therapy for HF patients. Additionally, we appreciate the support of the ACC and HRS on our CPT coding initiative, and the AMAs timely review process that opens the door to broader access for patients and providers.<\/p>\n
Many HF patients are treated with ICDs to protect against sudden death, but most do not treat HF itself. 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,” said Niraj Varma, M.D., Ph.D., Professor of Medicine and Director of Cardiac Pacing and Tachyarrhythmia at the Cleveland Clinic, and National Principal Investigator of the INTEGRA-D clinical trial. “Completing enrollment for this trial is an important step towards evaluating this device for patients that could potentially benefit.”\u00a0<\/p>\n
Each year, over 100,000 new ICDs are implanted in patients in the United States alone, adding to the estimated 800,000 individuals currently living with these devices\u00a0(1,2)<\/sup>. The CCM-D\u00ae HF System represents an important advancement, potentially offering these patients an option to life-saving technology and HF symptom relief. Additionally, the availability of CPT codes has expanded reimbursement pathways for the current Optimizer\u00ae device, helping increase access to this therapy for individuals living with heart failure, underscoring\u00a0\u00a0the maturation of CCM\u00ae therapy from an emerging innovation to a potentially established standard of care for HF patients. Together, these two milestones represent Impulse Dynamics\u00ae unwavering focus on driving meaningful innovation for the millions of patients living with HF.<\/p>\n About the INTEGRA-D Trial<\/b><\/p>\n The INTEGRA-D<\/sup>\u00a0trial is a multicenter, prospective, single-arm study evaluating the safety and efficacy of CCM-D\u00ae\u00a0HF System. This April, the initial defibrillation efficacy (DE) cohort results were presented by Dr. Niraj Varma as a late-breaking clinical trial at the 2025 Heart Rhythm conference in San Diego, which marked the completion of the efficacy phase of the trial.\u00a0The CCM-D\u00ae\u00a0device successfully converted induced ventricular fibrillation (VF) in 100 percent of the enrolled patients in the DE cohort, meeting the primary efficacy endpoint. Once six months of follow-up is completed, the data will be submitted to the U.S. Food and Drug Administration (FDA) in a Premarket Approval (PMA) application.<\/p>\n About the Optimizer\u00ae System and CCM\u00ae Therapy\u00a0\u00a0<\/b><\/p>\n The Optimizer\u00ae system delivers CCM\u00ae therapy the companys proprietary technology to the heart, providing clinically meaningful improvement to quality of life for appropriate HF patients. CCM\u00ae therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body[2]<\/sup>. CCM\u00ae 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. CCM\u00ae is the brand name for cardiac contractility modulation the non-excitatory electrical pulses delivered by the implantable Optimizer\u00ae device to improve heart contraction. CCM\u00ae therapy sends unique electrical pulses to the heart cells during the absolute refractory period. In doing so, CCM\u00ae helps the heart contract more forcibly. Impulse Dynamics\u00ae has completed numerous clinical studies, including several randomized controlled trials, the results of which appeared in more than 100 publications in leading medical journals.<\/p>\n About Impulse Dynamics\u00ae\u00a0<\/b><\/p>\n Impulse Dynamics\u00ae is dedicated to advancing the treatment of HF for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM\u00ae therapy, which uses the Optimizer\u00ae technology platform to improve quality of life in HF patients. CCM\u00ae therapy is delivered through the Optimizer\u00ae system, which includes an implantable pulse generator (IPG) implanted in a minimally invasive procedure and approved for commercial use in the United States and countries worldwide. More than 10,000 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. The company is currently engaged in another significant clinical trial called AIM HIGHer. The AIM HIGHer clinical trial is a multicenter study with the objective to evaluate the safety and efficacy of CCM\u00ae therapy in patients with symptomatic HF with an ejection fraction of 40 to 70 percent (inclusive). The trial is currently in its initial enrollment phase. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, X (formerly Twitter), and Facebook.<\/p>\n ###<\/p>\n References:<\/p>\n A OESP<\/b> nao e(sao) responsavel(is) por erros, incorrecoes, atrasos ou quaisquer decisoes tomadas por seus clientes com base nos Conteudos ora disponibilizados, bem como tais Conteudos nao representam a opiniao da OESP<\/b> e sao de inteira responsabilidade da GlobeNewswire<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"MARLTON, N.J., July 28, 2025 (GLOBE NEWSWIRE) — Impulse Dynamics\u00ae, a global medical device company committed to improving the lives of people with heart failure (HF), an","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[34],"tags":[],"class_list":["post-113696","post","type-post","status-publish","format-standard","hentry","category-releases-geral"],"acf":[],"_links":{"self":[{"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/posts\/113696","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/comments?post=113696"}],"version-history":[{"count":0,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/posts\/113696\/revisions"}],"wp:attachment":[{"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/media?parent=113696"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/categories?post=113696"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/tags?post=113696"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
![\"\"](\"https:\/\/ml.globenewswire.com\/media\/ZTY3MDk5ZjctZmNjNi00MDhiLTk4YjktYjE1N2JjOTQwZGE4LTEyMTg5NTYtMjAyNS0wNy0yOC1lbg==\/tiny\/Impulse-Dynamics.png\")
<\/p>\nHilary Schilmbach\nImpulse Dynamics\n856-642-9933\nhschlimbach@impulsedynamics.com\n\nRohan More\nImpulse Dynamics\n856-642-9933\nrmore@impulsedynamics.com\n<\/pre>\n