[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″]<\/p>\n
Mount Laurel, NJ, November 5, 2019<\/strong> \u2013 Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering Cardiac Contractility Modulation (also known as CCM\u2122 therapy), announced that it has secured transitional pass-through (TPT) payment for the Optimizer Smart System for the treatment of heart failure. In recent rulemaking, CMS has affirmed the substantial clinical improvement CCM offers to patients with heart failure and adjusted the payment offered for the technology accordingly to facilitate access. The new payment, issued on Friday, Nov. 1, 2019 in CMS\u2019s calendar year 2020 Outpatient Prospective Payment System (OPPS) final rule, eases access to CCM therapy in the hospital outpatient setting, with improved reimbursement taking effect on Jan. 1, 2020.<\/p>\n \u201cHeart failure patients in the U.S. received much needed assistance today in their quest for access to breakthrough treatment. Clinical improvements demonstrated by CCM therapy are now within reach,\u201d said Chris Baer, vice president of commercial operations, Impulse Dynamics. \u201cWe applaud CMS for recognizing the critical importance of improving patient access to Optimizer Smart technology. Because of this, hope is finally here for a very large population of heart failure patients who had until now gone without further treatment options.\u201d<\/p>\n The Optimizer Smart System offers CCM therapy for heart failure patients with reduced ejection fraction who are still suffering from the debilitating effects of the disease despite guideline-directed medical therapy. CCM is a unique electrical therapy delivered during the heart\u2019s absolute refractory period, which is just after the heart muscle contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm. It helps the heart contract more forcibly, increasing the efficiency of each beat.<\/p>\n \u201cFinally, we have an answer for a huge population of Class III heart failure patients who experience poor quality of life despite optimal medical management,\u201d said Dr. Gery Tomassoni an electrophysiologist and Director of Cardiology Research at Central Baptist Hospital in Lexington, KY. \u201cI am encouraged that CMS understands the important place CCM therapy represents in the treatment continuum for heart failure. Inadequate payment presents a major barrier for providers seeking to treat patients with breakthrough technologies. This ruling helps remove that barrier and will allow us to make CCM accessible for patients that currently have few alternatives.\u201d<\/p>\n The Optimizer Smart System is the only CCM device approved by the U.S. Food and Drug Administration to improve six-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 normal sinus rhythm, are not indicated for CRT, and have a left ventricular ejection fraction (LVEF) ranging from 25 to 45 percent. CCM aims to help the 70 percent of patients with chronic heart failure that are not eligible for CRT to manage their disease.<\/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 is the only Breakthrough Device to go before an FDA Advisory Committee (the Circulatory System Devices Panel) on Dec. 4, 2018, receiving a unanimous recommendation for approval based on their assessment of benefit versus risk. Optimizer then went on to receive FDA approval on March 21, 2019.<\/p>\n <\/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