Impulse News

Impulse Dynamics announces successful implantation of first patient since FDA approval of Optimizer® Smart System

ORANGEBURG, NY, May 8, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that the first patient to receive the Optimizer Smart System since the device was approved by the U.S. Food and Drug Administration was successfully implanted. The procedure, which occurred on Monday, May 6, at […]

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Impulse Dynamics receives FDA approval for breakthrough Optimizer® Smart System delivering CCM™ therapy for treatment of heart failure

Orangeburg, New York, March 21, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System. Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device […]

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FDA Panel Votes in Favor of the Optimizer® System

Orangeburg, New York, December 5, 2018 –Impulse Dynamics announces that the Circulatory System Devices Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of the Optimizer® System for patients with moderate to severe systolic heart failure. Cardiac Contractility Modulation is the name of a therapy that […]

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Clinical Registry Data and recently published FIX-HF-5C were presented at the Late-Breaking Clinical Trial Session at EHF 2018

Stuttgart, Germany, May 28th, 2018 – Impulse Dynamics Germany, GmbH announced results on “Real World” experience from its European Clinical Registry. The results were presented today by Prof. Gerd Hasenfuß, MD, Professor of Internal Medicine and Director of the Heart Center, University Hospital Göttingen, Germany at the Late-Breaking Clinical Trials Session of the European Heart […]

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FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the JACC: Heart Failure

Orangeburg, New York, May 10, 2018 – 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 […]

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The CFDA Approves Impulse Dynamics’ Optimizer System for Treatment of Chronic Heart Failure in China

Orangeburg, New York & Stuttgart, Germany. December 18, 2017 – The China Food and Drug Administration (CFDA) has approved Impulse Dynamics’ Optimizer® system for treatment of chronic heart failure.  The announcement was made on December 12, 2017 by Impulse Dynamics’ CEO, Dr. Simos Kedikoglou.  “This is a major milestone for Impulse Dynamics, as it will help […]

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Impulse Dynamics Announces First US Implant in the FIX-HF-5CA Continued Access Study.

Orangeburg, New York. August 7, 2017 – Impulse Dynamics announced today the first implant in the Company’s FIX-HF-5CA Continued Access Study. The FIX-HF-5CA study is a multicenter, prospective, single-arm Continued Access evaluation of the company’s Cardiac Contractility Modulation (CCM™) device. Impulse Dynamics proprietary CCM™ technology delivers non-excitatory electric pulses to the cardiac muscle with the […]

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Impulse Dynamics Completes $45 million Financing Round

Stuttgart, May 11, 2017 – Impulse Dynamics, developer of the revolutionary Cardiac Contractility Modulation (CCM™) technology for treatment of Chronic Heart Failure (CHF), announced today that the company has closed a $45 million financing round. The equity financing round was led by Goldstone Investment, a global investment company belonging to the Chinese conglomerate CITIC Securities, […]

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Randomization of the FIX-HF-5C Confirmatory Study Completed

Orangeburg, New York, March 31, 2017 — Impulse Dynamics is pleased to announce that it has successfully completed enrollment of the 160 subjects required for its FIX-HF-5C Confirmatory Study. The FIX-HF-5C Study is a prospective, multicenter, randomized study to evaluate the safety and efficacy of cardiac contractility modulation (CCM™) signals delivered by the implantable Optimizer® […]

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