{"id":242206,"date":"2025-06-25T18:15:18","date_gmt":"2025-06-25T22:15:18","guid":{"rendered":"https:\/\/impulse-dynamics.com\/global\/?p=242206"},"modified":"2025-06-25T18:15:23","modified_gmt":"2025-06-25T22:15:23","slug":"impulse-dynamics-receives-full-body-mri-conditional-approval-for-optimizer-smart-mini-system","status":"publish","type":"post","link":"https:\/\/impulse-dynamics.com\/global\/impulse-dynamics-receives-full-body-mri-conditional-approval-for-optimizer-smart-mini-system\/","title":{"rendered":"Impulse Dynamics Receives Full-Body MRI-Conditional Approval for Optimizer Smart Mini System"},"content":{"rendered":"

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PRESS\u00a0
RELEASE<\/h2>\n

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Reflecting Company Commitment to Innovation in Support of Patient Need<\/em><\/h2>\n
\n
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MARLTON, N.J., October 30, 2023\u00a0<\/strong>(GLOBE NEWSWIRE) \u2014 Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today it has received whole-body MRI-conditional approval for the Optimizer\u00ae<\/sup>\u00a0Smart Mini system from the United States Food and Drug Administration (FDA). The Optimizer Smart Mini system delivers the company\u2019s proprietary CCM\u00ae<\/sup>\u00a0therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.<\/p>\n

\u201cWe are pleased to receive approval for this important labeling change reflecting a necessary option for heart failure patients who likely receive multiple surgeries and benefit from the use of MRI imaging in the course of their treatment,\u201d said Jason Spees, CEO of Impulse Dynamics. \u201cThis furthers our commitment to supporting the heart failure patients who benefit from important and life-changing CCM therapy with the Optimizer Smart Mini system.\u201d<\/p>\n

\u201cFull body MRI capability is part of our promise to deliver an ongoing pace of innovation,\u201d said David Prutchi, Ph.D., Chief Technology Officer, Impulse Dynamics. \u201cThis advance will ensure that patients who can benefit from our CCM therapy are able to pursue the option without limiting important future diagnostic options.\u201d<\/p>\n

The Optimizer Smart Mini delivers CCM therapy to the heart. CCM therapy delivers precisely timed electrical pulses to the heart that are intended to improve the heart\u2019s ability to contract, allowing more oxygen-rich blood to be pushed out through the body.1<\/sup>\u00a0CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.<\/p>\n

The Optimizer Smart Mini incorporates a rechargeable battery with 20-year battery life, offering HF diagnostic monitoring that provides important clinical insights to providers to assist in managing their patients with heart failure. This latest generation also offers internal technology with improved programming and a smaller size designed to make the implant procedure faster and easier for patients and physicians.<\/p>\n<\/div>\n<\/div>\n

\n
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Reference<\/strong><\/p>\n

1 Kuschyk J, Falk P, Demming T, et al. Long\u2010term clinical experience with cardiac contractility modulation therapy delivered by the optimizer smart system. European Journal of Heart Failure. 2021;23(7):1160-1169. doi:10.1002\/ejhf.2202<\/p>\n<\/div>\n<\/div>\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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