Stuttgart– May 22, 2016 – Cardiac Contractility Modulation (CCM) Therapy delivered by the Optimizer System has, for the first time, been included in the European Society of Cardiology’s (ESC) 2016 guidelines for the diagnosis and treatment of acute and chronic heart failure (http://www.escardio.org/Guidelines-&-Education/Clinical-Practice-Guidelines/Acute-and-Chronic-Heart-Failure) released last week.
CCM Therapy is based on non-excitatory electric pulses that are delivered to the heart muscle and initiate multiple biochemical and neurohormonal changes in the myocardium. As a result, the contractility of the myocardium increases with no concomitant increase in oxygen consumption so that the heart works more efficiently and not harder. CCM is delivered by the Optimizer Device, which has already been successfully launched in Europe and is available in cardiology centers in various countries.
According to the ESC 2016 Guidelines, CCM has been evaluated in heart failure patients with reduced ejection fraction (HfrEF) in NYHA Classes II and III with normal QRS duration (<120 ms). An individual patient data meta-analysis demonstrated an improvement in exercise tolerance (peak VO2) and quality of life (Minnesota Living with Heart Failure questionnaire). Thus CCM may be considered in selected patients with heart failure (those NYHA Class II-III without a CRT indication).
CCM therapy has been implanted in over 3000 patients to date and is the only device therapy available for patients with normal QRS complex.
“A reference in the ESC guidelines is the first step towards full validation of the CCM technology for heart failure patients” said Dr. Simos Kedikoglou, Chief Executive Officer of Impulse Dynamics. “Impulse Dynamics has an extensive clinical plan that includes over 100 clinical sites to further add clinical evidence for CCM’s efficacy and ultimately benefit more heart failure patients. “
The Optimizer IVs device which delivers CCM therapy has been successfully launched in Europe and other international markets and is available in a growing number of cardiology centers around the world. The therapy has been implanted in about 3,000 patients to date and is the only device therapy available for patients with narrow QRS complex. Impulse Dynamics has completed a vast number of clinical studies, including several randomized controlled trials, as published in over 60 publications in leading medical journals. The Optimizer IVs is limited to investigational use in the USA.
Impulse Dynamics N.V., a member of the Hobart Group companies, is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the US, Europe, Asia and Australia. For more information please visit www.impulse-dynamics.com.
The Hobart Group accelerates ideas and develops and commercializes medical technologies, targeting top healthcare markets with significant unmet needs. Its growing portfolio of companies covers the fields of cardiology, diabetes, oncology, neurology and rehabilitation. Together, Hobart Group companies employ over 200 scientists, engineers, regulatory and business experts across four continents, benefitting from the group’s financial strength, clinical expertise and extensive international market knowledge across Europe, the US and Asia. For more information please visit www.hobart-group.com.
CCM and Optimizer are trademarks of Impulse Dynamics N.V.