{"id":242249,"date":"2025-06-25T18:58:32","date_gmt":"2025-06-25T22:58:32","guid":{"rendered":"https:\/\/impulse-dynamics.com\/global\/?p=242249"},"modified":"2025-06-25T18:58:36","modified_gmt":"2025-06-25T22:58:36","slug":"impulse-dynamics-receives-european-ce-mark-for-expanded-indication-for-diastolic-heart-failure","status":"publish","type":"post","link":"https:\/\/impulse-dynamics.com\/global\/impulse-dynamics-receives-european-ce-mark-for-expanded-indication-for-diastolic-heart-failure\/","title":{"rendered":"Impulse Dynamics Receives European CE Mark For Expanded Indication For Diastolic Heart Failure"},"content":{"rendered":"

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PRESS\u00a0
RELEASE<\/h2>\n

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CCM therapy is now indicated for symptomatic heart failure patients with diastolic or systolic ventricular dysfunction, offering a broader range of patients a new option for improving quality of life and reducing heart failure hospitalization<\/em><\/h2>\n

MARLTON, N.J., March 28, 2025\u00a0<\/strong>(GLOBE NEWSWIRE) \u2014 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 received European CE Mark approval for an expanded indication for the Optimizer\u00ae<\/sup>\u00a0Smart Mini system, which delivers the company\u2019s proprietary CCM\u00ae<\/sup>\u00a0therapy. This new indication now offers millions of patients with diastolic HF a way to alleviate debilitating symptoms, improving their quality of life and reducing hospitalizations related to heart failure.\u00a0[i]<\/a><\/p>\n

\u201cThis expanded indication addresses an important unmet clinical need for patients with diastolic HF or HF with preserved ejection fraction (HFpEF), as it is now also called,\u201d said Prof. Stefan Anker, MD, of Charit\u00e9 Berlin, Germany. \u201cThese patients currently have only a few effective treatment options, therefore, the new development by Impulse Dynamics is most welcome. HF specialists in Europe now have an approved device-based treatment for diastolic HF patients that has been shown to improve quality of life and to reduce their need for HF-related hospitalizations.\u201d<\/p>\n

\u201cImpulse Dynamics has established leadership and commitment to significantly changing the treatment options available for HF patients,\u201d said Jason Spees, CEO of Impulse Dynamics. \u201cThe expanded indication for CCM therapy in Europe is a reflection of the company\u2019s drive to provide proven treatment solutions for all HF patients.\u201d<\/p>\n

HF affects more than 64 million people worldwide and causes symptoms like fatigue, shortness of breath, and swelling that can severely limit daily activities and overall quality of life.[ii]<\/a>\u00a0Diastolic HF accounts for almost half of the HF population[iii]<\/a>\u00a0and occurs when the heart\u2019s ventricles become stiff and unable to relax properly, preventing them from filling with enough blood between beats. These patients have limited treatment options available for managing their symptoms.<\/p>\n

In Europe, the OPTIMIZER Smart Mini system is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic and diastolic left ventricular dysfunction despite appropriate medical therapy. CCM therapy, as delivered by the OPTIMIZER system, has been shown to improve the clinical status, functional capacity, and quality of life, and prevent hospital admissions in patients with symptomatic left heart failure in eligible patients.<\/p>\n

[i]<\/a>\u00a0Kuschyk, J., Falk, P., Demming, T., Marx, O., Morley, D., Rao, I., & Burkhoff, D. (2021). Long\u2010term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system.\u00a0European journal of heart failure<\/em>,\u00a023<\/em>(7), 1160-1169.<\/p>\n

[ii]<\/a>\u00a0Groenewegen, A., Rutten, F. H., Mosterd, A., & Hoes, A. W. (2020). Epidemiology of heart failure.\u00a0European journal of heart failure<\/em>,\u00a022<\/em>(8), 1342-1356.<\/p>\n

[iii]<\/a>\u00a0Cleland, J. G. F., Swedberg, K., Follath, F., Komajda, M., Cohen-Solal, A., Aguilar, J. C., \u2026 & Mason, J. (2003). The EuroHeart Failure survey programme\u2014a survey on the quality of care among patients with heart failure in Europe: Part 1: patient characteristics and diagnosis.\u00a0European heart journal<\/em>,\u00a024<\/em>(5), 442-463.<\/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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