[et_pb_section fb_built=”1″ _builder_version=”4.0.6″ custom_padding=”||2px|||”][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”1″ _builder_version=”4.0.4″ background_color=”#00a1e4″ width=”100%” max_width=”1920px” min_height=”462px” custom_margin=”-56px|auto||auto|false|false” custom_padding=”||0px|||”][et_pb_column type=”1_3″ _builder_version=”4.0.4″][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″ header_2_font=”|300|||||||” header_2_text_color=”#ffffff” header_2_font_size=”80px” header_2_letter_spacing=”5px” custom_margin=”78px||||false|false”]<\/p>\n
[\/et_pb_text][et_pb_divider color=”#005496″ _builder_version=”4.0.4″ width=”53%” module_alignment=”center” custom_margin=”36px||||false|false”][\/et_pb_divider][et_pb_text _builder_version=”4.0.6″ header_font=”|||on|||||” header_4_font=”|||on|||||” header_4_text_color=”#FFFFFF” header_4_font_size=”30px”]<\/p>\n
[\/et_pb_text][et_pb_divider color=”#005496″ _builder_version=”4.0.4″ width=”53%” module_alignment=”center” custom_margin=”16px||||false|false”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.0.4″][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.0.6″ custom_padding=”0px|||||”][et_pb_row _builder_version=”4.0.6″ custom_padding=”||0px|||”][et_pb_column type=”4_4″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″ header_2_text_color=”#005496″ custom_margin=”||7px|||” custom_padding=”||0px|||” hover_enabled=”0″]Orangeburg, New York, March 21, 2019<\/strong>\u00a0\u2013 Impulse Dynamics, developer of the implantable Optimizer\u00ae<\/sup>\u00a0Smart System for delivering CCM\u2122 therapy, announced today that it has\u00a0received approval from the United States Food and Drug Administration<\/a>\u00a0for its first-in-class Optimizer Smart System.<\/p>\n Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It was the first breakthrough device to go before the Circulatory System Devices Panel of the FDA\u2019s Medical Devices Advisory Committee, on Dec. 4, 2018, receiving a 12-0 vote on the benefit-to-risk ratio of the device.<\/p>\n \u201cWith the FDA\u2019s approval of the Optimizer System for the delivery of CCM, we finally have available in the US an effective device-based therapy for advanced heart failure patients with mildly to moderately reduced left ventricular ejection fractions who are not eligible for CRT,\u201d said Professor William T. Abraham, MD, Professor of Medicine, Physiology, and Cell Biology, and College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center. \u201cThe Optimizer System, along with guideline-directed medical therapies, can improve the lives of many heart failure patients in the US who previously did not have access to this therapy. As such, it represents a real game-changer for these patients.\u201d<\/p>\n The Optimizer Smart System is the first and only CCM device approved by the FDA to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in\u00a0normal sinus rhythm, are not indicated for CRT, and have an LVEF ranging from 25% to 45%. Only 30 percent of moderate to severe chronic heart failure patients are candidates for CRT, which historically has left 70 percent of patients with few options to help them manage their disease.<\/p>\n \u201cFDA approval is the culmination of many years of clinical development for this disruptive technology, addressing a significant unmet need in today\u2019s heart failure treatment paradigm,\u201d commented Dr. Daniel Burkhoff, Impulse Dynamics\u2019 Medical Advisor. \u201cWe continue to develop the technology with ongoing clinical trials designed to evaluate CCM therapy in additional heart failure populations.\u201d<\/p>\n CCM is a unique electrical pulse delivered during the absolute refractory period, which is just after the heart contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.<\/p>\n Dr. Simos Kedikoglou, Impulse Dynamics\u2019 CEO, announced that the Company will launch the device in the US later this year.\u00a0 \u201cWe are extremely excited that the Optimizer Smart System with CCM therapy is now available in the United States,\u201d he said. \u201cWe look forward to growing our commercial presence in the US and globally.\u201d<\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.0.6″ background_color=”#005496″ custom_padding=”37px|36px|37px|36px|true|true”][et_pb_column type=”1_3″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″ background_layout=”dark”]<\/p>\n About the Optimizer and CCM Therapy <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″ background_layout=”dark”]<\/p>\n About Impulse Dynamics [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″ background_layout=”dark”]<\/p>\n Impulse Dynamics (USA), Inc.<\/strong> [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.0.4″ background_color=”#005496″ custom_margin=”-8px|||||” custom_padding=”0px||0px||true” global_module=”79″ saved_tabs=”all” collapsed=”off”][et_pb_row use_custom_gutter=”on” gutter_width=”2″ custom_padding_last_edited=”on|tablet” _builder_version=”4.0.6″ max_width=”1400px” custom_padding=”15px||5px||false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=””][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_signup mailchimp_list=”Impulse Dynamics|b1aca3c5b7″ ip_address=”off” first_name_field=”off” last_name_field=”off” title=”IMPULSE DYNAMICS NEWSLETTER” button_text=”SIGN UP” description=”<\/p>\n Sign up to receive our monthly newsletter <\/p>\n ” footer_content=”<\/p>\n
<\/strong>CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart\u2019s cardiac cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 4,000 patients and is currently available in the US, Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and the results have been published in over 80 articles appearing in leading medical journals.<\/p>\n
<\/strong>Impulse Dynamics is a medical device company dedicated to transforming the treatment of chronic heart failure. With global headquarters in Mount Laurel, N.J., the company has additional offices in; Stuttgart, Germany, Orangeburg, N.Y. and Curacao For more information please visit\u00a0<\/span>www.impulse-dynamics.com<\/a>.<\/p>\n
523 Fellowship Road, Suite 203
Mt. Laurel, NJ 08054<\/p>\n