Impulse Dynamics Launches the Cardiac Contractility Modulation (CCM-HF) Study in Europe Using the Optimizer System

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Impulse Dynamics has initiated the Cardiac Contractility Modulation (CCM-HF) trial, a European study assessing the impact of CCM on hospitalizations and all-cause mortality associated with Heart Failure, in parallel to the FDA FIX-HF-5B confirmatory study already underway in the US.

Cardiac Contractility Modulation Therapy

CCM signals normalize the protein function in a dog model of CHF

CCM therapy is delivered through the Optimizer III . . . and has been shown to significantly improve exercise tolerance and quality of life in implanted patients suffering from symptomatic heart failure.

Impulse Dynamics launched today the CCM-HF Study. The study is designed to assess the impact of Cardiac Contractility Modulation (CCM) on the composite of heart failure hospitalizations and all-cause mortality in two separate cohorts of heart failure patients with a narrow QRS: a low ejection fraction (EF<35%) cohort and a mildly reduced ejection fraction (35%< EF< 45%) cohort. Up to 600 patients- 300 implanted plus 300 matched control patients will be enrolled into this European multi-center study and will be followed for 24 months post implantation. The study is chaired by a steering committee that includes Prof. Dr. K.-H. Kuck, Prof. Dr. A. Auricchio, and Prof. Dr. B.A. Remppis.

“This exciting new study will allow us to examine the effect of CCM treatment in a population of patients that suffers from mildly reduced ejection fraction in the range of 35%-45%, among others. We suspect this patient subgroup can benefit significantly from CCM therapy, as indicated by encouraging results from previous studies conducted in the US by Impulse Dynamics”, said Prof. Dr. K.-H. Kuck, Head of the Department of Cardiology at the Asklepios Klinik, St. Georg, Hamburg. “The Optimizer system is currently the only device-based treatment for this patient population, which is not indicated for Cardiac Resynchronization Therapy (CRT).

“The CCM-HF Study is an important landmark in Impulse Dynamics’ clinical activity”, said Dr. Oern Stuge, Impulse Dynamics Executive Chairman. “CCM therapy is delivered through the Optimizer III, which has been implanted in more than 1,000 patients over the past eight years, and has been shown to significantly improve exercise tolerance and quality of life in implanted patients suffering from symptomatic heart failure.”

The CCM-HF trial comes only a few months after the company initiated a confirmatory study in the US. “The FIX-HF-5B confirmatory study is being conducted in the US under an IDE approved by the FDA, and is designed to confirm the safety and efficacy of the Optimizer III implant in patients with moderate heart failure,” explained Impulse Dynamics’ Medical Director, Daniel Burkhoff MD, PhD. “The US study, which will recruit 230 patients randomized to receive CCM treatment or continued medical management, is the next important step in seeking FDA approval for commercial marketing of the Optimizer in the US, and has already enrolled its first patients.”

About CCM Therapy
Cardiac Contractility Modulation (CCM) is a unique and innovative method for treating patients with moderate-to-severe chronic heart failure that are symptomatic despite optimal medical therapy. CCM signals are non-excitatory electric pulses delivered by the Optimizer III implantable device during a specific period of the heart cycle called the absolute refractory period. Research has shown that CCM signals significantly improve the heart’s contractility by normalizing the function and expression of key regulatory proteins in the heart muscle and, through that, the contractility of the heart. Studies in both animals and human subjects have demonstrated that CCM therapy does not result in a detectable increase in myocardial oxygen consumption (MVO2).

About Impulse Dynamics
Impulse Dynamics is a medical device company dedicated to offering innovative solutions for treatment of Chronic Heart Failure. The Optimizer III with CCM therapy is CE marked and is available in select excellence centers across Europe and Asia.

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Matthias Vogt
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