{"id":3034,"date":"2017-08-08T04:30:13","date_gmt":"2017-08-08T04:30:13","guid":{"rendered":"http:\/\/impulse-dynamics-multisite.flywheelsites.com\/ous\/int\/?post_type=news&amp;p=3034"},"modified":"2017-08-08T04:30:13","modified_gmt":"2017-08-08T04:30:13","slug":"impulse-dynamics-announces-first-us-implant-fix-hf-5ca-continued-access-study","status":"publish","type":"news","link":"https:\/\/impulse-dynamics.com\/global\/news\/impulse-dynamics-announces-first-us-implant-fix-hf-5ca-continued-access-study\/","title":{"rendered":"Impulse Dynamics Announces First US Implant in the FIX-HF-5CA Continued Access Study."},"content":{"rendered":"<p><strong>Orangeburg, New York. August 7, 2017<\/strong> \u2013 Impulse Dynamics announced today the first implant in the Company\u2019s FIX-HF-5CA Continued Access Study. The FIX-HF-5CA study is a multicenter, prospective, single-arm Continued Access evaluation of the company\u2019s Cardiac Contractility Modulation (CCM) device. Impulse Dynamics proprietary CCM technology delivers non-excitatory electric pulses to the cardiac muscle with the potential for improved exercise capacity and quality of life.<\/p>\n<p>The study allows ongoing access to treatment for up to 250 patients suffering from moderate to severe heart failure, as Impulse Dynamics prepares to submit the PMA application to the FDA for the Optimizer device later this year. The first US implant was performed by Rodrigo Chan MD of the Chan Heart Rhythm Institute in Mesa, Arizona on August 5, 2017. <\/p>\n<p>As part of the Continued Access study, the protocol includes the \u201cOptimizer SMART\u201d device, which is slightly smaller and more physiologically shaped than previous models. \u201cIncluding the Optimizer SMART in the FIX-HF-5CA study serves patients with heart failure by giving them access to recent improvements in the CCM Technology portfolio\u201d said Dr. Simos Kedikoglou, Impulse Dynamics\u2019 CEO.  \u201cWe are confident that the data gained in our continued access study will positively contribute to the body of evidence supporting our therapy and look forward to including these results in the PMA submission\u201d<\/p>\n<p>Additional information can be found on the Clinicaltrials.gov website at <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03102437\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03102437<\/a> <\/p>\n<h3>About the Optimizer and CCM Therapy<\/h3>\n<p>Over 3,500 patients worldwide have received CCM through an Optimizer device, the innovative therapy of which is designed for patients with a narrow QRS complex, reduced ejection fraction and advanced heart failure. Impulse Dynamics has completed extensive clinical studies, including several randomized controlled trials, published in articles in over 60 leading medical journals. The Optimizer is approved in the United States for investigational use only. An advanced version of the device, the Optimizer Smart, has been successfully launched in Europe where it is available in a growing number of cardiology centers.<\/p>\n<h3>About Impulse Dynamics<\/h3>\n<p>Impulse Dynamics N.V., a member of the Hobart Group of companies, 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, Asia and Australia.  For more information, please visit www.impulse-dynamics.com.<\/p>\n<p>CCM and Optimizer are trademarks of Impulse Dynamics N.V.<\/p>\n<p><strong>Impulse Dynamics (USA), Inc.<\/strong><br \/>\n30 Ramland Road South, Suite 204<br \/>\nOrangeburg, NY 10962<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-3034","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>Impulse Dynamics Announces First US Implant in the FIX-HF-5CA Continued Access Study. - 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\/impulse-dynamics-announces-first-us-implant-fix-hf-5ca-continued-access-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Impulse Dynamics Announces First US Implant in the FIX-HF-5CA Continued Access Study. - Global - Impulse Dynamics\" \/>\n<meta property=\"og:description\" content=\"Orangeburg, New York. August 7, 2017 \u2013 Impulse Dynamics announced today the first implant in the Company\u2019s FIX-HF-5CA Continued Access Study. The FIX-HF-5CA study is a multicenter, prospective, single-arm Continued Access evaluation of the company\u2019s Cardiac Contractility Modulation (CCM) device. 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August 7, 2017 \u2013 Impulse Dynamics announced today the first implant in the Company\u2019s FIX-HF-5CA Continued Access Study. The FIX-HF-5CA study is a multicenter, prospective, single-arm Continued Access evaluation of the company\u2019s Cardiac Contractility Modulation (CCM) device. 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