Orangeburg, NY – July 28, 2014 – Impulse Dynamics (USA), Inc. announced today that enrollment has commenced in FIX-HF-5C Confirmatory Study. The study is designed to evaluate the safety and efficacy of the Optimizer™ IVs System in moderate to severe heart failure patients with an LVEF of 25-45% and a QRS <130ms.
The study will include 230 randomized patients, with an equal chance of receiving the Optimizer System with CCM therapy or in the Control group (optimal medical therapy). The study is taking place in the United States, Germany and the Czech Republic. The company is expecting enrollment of 230 subjects to be completed within approximately a year at up to 40 centers in the US and Europe.
“We are pleased to be participating in the clinical study of the Optimizer System which has the potential to help heart failure patients with a narrow QRS” said Stanislav Weiner, M.D., Principal Investigator at Trinity Clinic. “There are currently no other device-based options for this large group of heart failure patients that are not adequately controlled with pharmaceutical treatment alone. As a clinician, I would like to have additional FDA approved treatment to offer to our patients in this category.”
Dr. Simos Kedikoglou, Chief Executive Officer of Impulse Dynamics commented: “The results from our US pivotal study suggest that patients with an EF of 25-45% are particularly responsive to CCM therapy. Today is the first step to prospectively confirm this hypothesis and obtain FDA approval to provide this novel therapy to patients in the United States similar to their counterparts in Europe.”
Additional information can be found on the ClinicalTrials.gov website.
About the Optimizer™ IVs device and CCM Therapy
The Optimizer™ IVs delivers Cardiac Contractility Modulation (CCM) therapy, a unique and innovative method for treating moderate to severe heart failure, by delivering non-excitatory pulses to the heart. The Optimizer™ IVs System has been successfully launched in Europe and is available in cardiologycenters in various countries. The device has been implanted in over 2000 patients to date and is the only device therapy available for patients with narrow QRS complex. Impulse Dynamics has completed a numerous clinical studies, including several randomized controlled trials. The results have been published in over 60 publications in leading medical journals. The Optimizer system is limited to Investigational use only in the United States.
About Impulse Dynamics
Impulse Dynamics N.V. is focused on the development of electrical therapies for the treatment of chronic heart failure. Impulse Dynamics is a global leader in cardiac medical innovation and has operations in the US, Europe, Asia and Australia. For more information please visit www.impulse-dynamics.com
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