{"id":242253,"date":"2025-06-25T19:02:20","date_gmt":"2025-06-25T23:02:20","guid":{"rendered":"https:\/\/impulse-dynamics.com\/global\/?p=242253"},"modified":"2025-06-25T19:02:24","modified_gmt":"2025-06-25T23:02:24","slug":"impulse-dynamics-integra-d-trial-completes-efficacy-phase","status":"publish","type":"post","link":"https:\/\/impulse-dynamics.com\/global\/impulse-dynamics-integra-d-trial-completes-efficacy-phase\/","title":{"rendered":"Impulse Dynamics\u00ae\u2019 INTEGRA-D Trial Completes Efficacy Phase"},"content":{"rendered":"

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PRESS\u00a0
RELEASE<\/h2>\n

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First phase of enrollment of single device for CCM\u00ae and ICD therapy complete<\/em><\/h2>\n

MARLTON, N.J., April 28, 2025\u00a0<\/strong>(GLOBE NEWSWIRE) \u2014 Impulse Dynamics\u00ae<\/sup><\/strong>\u00a0plc, 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\u2122<\/sup>\u00a0clinical 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\u00ae<\/sup><\/strong>\u00a0HF System, which combines Impulse Dynamics\u00ae<\/sup><\/strong>\u2019 proprietary CCM\u00ae<\/sup><\/strong>\u00a0therapy for the treatment of HF symptoms with implantable cardioverter defibrillator (ICD) therapy.<\/p>\n

The CCM-D\u00ae<\/sup><\/strong>\u00a0device successfully converted induced ventricular fibrillation (VF) in patients in the trial, meeting the primary efficacy endpoint \u2013 conversion of induced VF to a normal rhythm at the time of device implantation \u2013 in 100 percent of patients enrolled consecutively in the INTEGRA-D\u2122<\/sup>\u00a0trial.<\/p>\n

\u201cMost of these patients experience severe heart failure symptoms and a reduced quality of life,\u201d 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\u2122<\/sup>\u00a0trial.\u201cThese patients often receive a standard ICD that does not relieve heart failure symptoms. The INTEGRA-D\u2122<\/sup>\u00a0trial aims to evaluate a new type of device \u2013 CCM-D\u00ae\u00a0\u00a0<\/sup><\/strong>HF System \u2013 designed to address this treatment gap by offering symptom relief for patients with heart failure.\u201d<\/p>\n

\u201cWe are pleased with the progress of our INTEGRA-D\u2122<\/sup>\u00a0clinical trial, which continues to deliver on our commitment to advance therapy for HF patients,\u201d said Jason Spees, CEO, Impulse Dynamics\u00ae<\/sup><\/strong>. \u201cIn the United States, around 800,000 people have ICDs, with about 150,000 new ICDs implanted each year\u00a0[1]<\/sup>. The CCM-D\u00ae<\/sup><\/strong>\u00a0HF System is a significant innovation that will give those patients an option for life-saving technology that also helps restore their quality of life.\u201d<\/p>\n

\u201cThese result of defibrillator efficacy testing with CCM-D\u00ae<\/sup><\/strong>\u00a0opens a potential new pathway to manage HF patients in the future\u201d, 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\u2122<\/sup>\u00a0clinical trial. \u201cWe are looking forward to continuing to study this new therapy and understanding its potential role in cardiac care for HF patients.\u201d<\/p>\n

The INTEGRA-D\u2122<\/sup>\u00a0trial is a multicenter, prospective, single-arm study evaluating the safety and efficacy of CCM-D\u00ae<\/sup><\/strong>\u00a0HF System in 300 patients.\u00a0 The trial is nearing enrollment completion, and a Premarket Approval (PMA) will be filed with the full safety and efficacy outcomes after completing six-month follow-up.<\/p>\n

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Forward-looking Statements<\/strong><\/p>\n

This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as \u2018\u2018may,\u2019\u2019 \u2018\u2018will,\u2019\u2019 \u2018\u2018should,\u2019\u2019 \u2018\u2018expect,\u2019\u2019 \u2018\u2018plan,\u2019\u2019 \u2018\u2018anticipate,\u2019\u2019 \u2018\u2018could,\u2019\u2019 \u2018\u2018intend,\u2019\u2019 \u2018\u2018target,\u2019\u2019 \u2018\u2018project,\u2019\u2019 \u2018\u2018contemplate,\u2019\u2019 \u2018\u2018believe,\u2019\u2019 \u2018\u2018estimate,\u2019\u2019 \u2018\u2018predict,\u2019\u2019 \u2018\u2018potential\u2019\u2019 or \u2018\u2018continue\u2019\u2019 or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning potential benefits of CCM therapy, and the absence of risks associated therewith; the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer Smart Mini and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. These forward-looking statements are based on management\u2019s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release include, without limitation: the company\u2019s future research and development costs, capital requirements and the company\u2019s needs for additional financing; commercial success and market acceptance of CCM therapy; the company\u2019s ability to achieve and maintain adequate levels of coverage or reimbursement for Optimizer Smart and Optimizer Smart Mini systems or any future products the company may seek to commercialize; competitive companies and technologies in the industry; the company\u2019s ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the company\u2019s business model and strategic plans for its products, technologies and business, including its implementation thereof; the company\u2019s ability to expand, manage and maintain its direct sales and marketing organization; the company\u2019s ability to commercialize or obtain regulatory approvals for CCM therapy and its products, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; and the company\u2019s ability to establish and maintain intellectual property protection for CCM therapy and products or avoid claims of infringement. The company does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the company\u2019s views as of any date subsequent to the date of this press release.<\/p>\n

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About Impulse Dynamics<\/strong>
Impulse Dynamics, based in Marlton, N.J., is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCM<\/em><\/strong>\u00ae<\/sup><\/span> therapy, which is delivered by the company\u2019s Optimizer system, a breakthrough, FDA-approved treatment verified to improve the quality of life for heart failure patients.[1]<\/a> CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few alternatives available to them.1<\/sup> \u00a0To learn more, visit www.ImpulseDynamics.com<\/a>, or follow the company on social media at LinkedIn<\/a>, Twitter<\/a>, and Facebook<\/a>. [1]<\/a> https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5494150\/<\/a><\/p>\n

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\nImpulse Dynamics (USA), Inc.<\/strong>
50 Lake Center Executive Park, 401 Route 73 N, \u2010 Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642\u20109933
www.impulse\u2010dynamics.com<\/p>\n

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INVESTOR<\/strong> CONTACT<\/strong>:<\/p>\n

Harriss Currie
CFO
Impulse Dynamics
hcurrie@impulsedynamics.com<\/a>
856-642-9933<\/p>\n

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MARKETING CONTACT: <\/strong>\u00a0<\/strong><\/p>\n

Rohan More
\nDirector of Media Relations
\nImpulse Dynamics
\nrmore@impulsedynamics.com<\/a>
\n856-642-9933<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_text _builder_version=”4.16″ text_font_size=”13px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” global_colors_info=”{}” theme_builder_area=”post_content”]<\/p>\n

PUBLIC RELATIONS: <\/strong>\u00a0<\/strong><\/p>\n

Ian Segal
Manager, Public Relations
Impulse Dynamics
isegal@impulsedynamics.com<\/a>
856-642-9933<\/p>\n

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