Orangeburg, NY – August 4, 2014 Impulse Dynamics (USA), Inc. announced today that the first US implant of the Optimizer™ IVs System in the FIX-HF-5C Confirmatory Study was performed by Stanislav Weiner, M.D. at Mother Frances Hospital in Tyler, Texas. 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.
Simos Kedikoglou, CEO of Impulse Dynamics said: “The first implantation in the Fix-HF-5C Confirmatory Study takes Impulse Dynamics a step closer to submitting for FDA approval of the Optimizer™ IVs System. We look forward to a swift completion of the study and to being able to provide the therapy to patients with Heart Failure in the United States.”
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 cardiology centers 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™ IVs 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
Recent Comments