{"id":3096,"date":"2018-05-10T18:29:55","date_gmt":"2018-05-10T18:29:55","guid":{"rendered":"http:\/\/impulse-dynamics-multisite.flywheelsites.com\/ous\/int\/?post_type=news&amp;p=3096"},"modified":"2018-05-10T18:29:55","modified_gmt":"2018-05-10T18:29:55","slug":"fix-hf-5c-late-breaking-clinical-trial-data-presented-at-hrs-2018","status":"publish","type":"news","link":"https:\/\/impulse-dynamics.com\/global\/news\/fix-hf-5c-late-breaking-clinical-trial-data-presented-at-hrs-2018\/","title":{"rendered":"FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the JACC: Heart Failure"},"content":{"rendered":"<p>Orangeburg, New York, May 10, 2018 \u2013 Impulse Dynamics (USA), Inc. announced results from its FIX-HF-5C randomized, Controlled Trial of Cardiac Contractility Modulation in Heart Failure. The study results were presented by Prof. William Abraham, MD, Professor of Internal Medicine and Director, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, at the Heart Rhythm Society Late-Breaking Clinical Trials today in Boston, Massachusetts, with a simultaneous publication in the JACC: Heart Failure Journal.<\/p>\n<div id=\"attachment_2962\" style=\"width: 260px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-2962\" class=\"wp-image-2962\" src=\"https:\/\/impulse-dynamics.com\/ous\/int\/wp-content\/uploads\/sites\/2\/sites\/2\/2017\/03\/William-T-Abraham-photo-January-2016_450.jpg\" alt=\"\" width=\"250\" height=\"333\" \/><p id=\"caption-attachment-2962\" class=\"wp-caption-text\">Prof. William Abraham, MD, Professor of Internal Medicine and Director, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center<\/p><\/div>\n<p>CCM\u2122 is a therapy unique to the Optimizer\u00ae family of devices that deliver electrical signals to the heart that are intended to reduce symptoms and improve exercise tolerance in patients with heart failure.\u00a0 The FIX-HF-5C study was designed to prospectively confirm a subgroup analysis of the prior FIX-HF-5 pivotal trial, showing that CCM\u2122 significantly improved exercise tolerance and quality of life in patients with NYHA class III and IV heart failure symptoms, ejection fraction 25-45%, and a QRS &lt;130ms. A Bayesian statistical analysis plan was developed to combine the data already available from the original FIX-HF-5 study with the FIX-HF-5C study data. The results presented today at HRS supplement and confirm the results from the prior study, meeting the safety and effectiveness objectives of the study.<\/p>\n<p>Highlights of the results include:<\/p>\n<ul>\n<li>CCM\u2122 is safe; the study met its primary and secondary safety endpoints.<\/li>\n<li>Patients receiving CCM\u2122 showed significantly better exercise tolerance and quality of life compared to their control-group counterparts.<\/li>\n<li>The composite of cardiovascular deaths and heart failure hospitalizations was statistically significantly reduced in comparison to the control group.<\/li>\n<li>Clinical effectiveness was even greater in patients with EF <u>&gt;<\/u>35%.<\/li>\n<\/ul>\n<p>\u201cThe results of the FIX-HF-5C study exceeded my expectations by not only confirming the benefits of CCM\u2122 on important patient-centered endpoints such as exercise capacity and quality of life, but also in demonstrating the potential for CCM\u2122 to reduce heart failure morbidity and mortality\u201d said Prof. Abraham. \u201cThese findings support the use of CCM\u2122 as a breakthrough therapy for heart failure patients with moderately reduced left ventricular systolic function and narrow QRS durations, who currently have no other options for improvement.\u201d<\/p>\n<p>\u201cI would like to thank the FIX-HF-5C Study Investigators and the Impulse Dynamics&#8217; team for completing this important study with its very encouraging results.\u201d said Dr. Simos Kedikoglou, Impulse Dynamics\u2019 CEO.\u00a0 \u201cWe anticipate submission of the final PMA module to the U.S. FDA in June 2018.\u201d<\/p>\n<p><strong>About the Optimizer\u00ae and CCM\u2122 Therapy<\/strong><br \/>\nCCM\u2122 is the brand name for the nonexcitatory electrical pulses delivered by the implantable Optimizer\u00ae device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer\u00ae system has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India and several other countries around the world.\u00a0 Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 70 publications in leading medical journals. The Optimizer\u00ae is limited to Investigational use only in the United States.<\/p>\n<p><strong>About Impulse Dynamics<\/strong><br \/>\nImpulse Dynamics N.V. is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit <a href=\"https:\/\/impulse-dynamics.com\/ous\">www.impulse-dynamics.com<\/a>.<\/p>\n<p><strong>Impulse Dynamics (USA), Inc.<\/strong><br \/>\n30 Ramland Road South, Suite 204<br \/>\nOrangeburg, NY 10962<\/p>\n<p><strong>For media enquiries<br \/>\n<\/strong>Mrs. Sharon Alon<br \/>\nTel: +1-347-761-3342<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-3096","news","type-news","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the JACC: Heart Failure - Global - Impulse Dynamics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/impulse-dynamics.com\/global\/news\/fix-hf-5c-late-breaking-clinical-trial-data-presented-at-hrs-2018\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the JACC: Heart Failure - Global - Impulse Dynamics\" \/>\n<meta property=\"og:description\" content=\"Orangeburg, New York, May 10, 2018 \u2013 Impulse Dynamics (USA), Inc. announced results from its FIX-HF-5C randomized, Controlled Trial of Cardiac Contractility Modulation in Heart Failure. 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