Stuttgart, Germany, July 3rd, 2014 – Impulse Dynamics received Ethical Committee approvals in Germany for its two main randomized controlled clinical studies on CCM™ therapy for heart failure patients, the FIX-HF-5C and the IMPULSE-HF studies.
Both studies have Peak VO2 as the primary efficacy end-point to be evaluated over a period of 24 weeks. The studies will enroll heart failure patients who are symptomatic despite optimal medical therapy, with normal QRS duration and Ejection Fraction of up to 45%.
The FIX-HF-5C study will include patients with NYHA class III-IV symptoms from sites in the US, Germany and Czech Republic, and is designed as a confirmatory study for the purpose of obtaining the US FDA approval for the CCM™ therapy using the Optimizer™ IVs implantable system. The study obtained an affiliate status from DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung E.V.) – the German Centre for Cardiovascular Research, an association of major universities that perform cutting edge research in circulatory diseases.
The IMPULSE-HF study will include patients with NYHA class II-III symptoms, and has an adaptive design, initially targeting enrollment of 100 patients and will take place in large medical centers in several European countries.
So far, CCM™ therapy was evaluated in a variety of studies, and in particular in 3 randomized controlled studies that enrolled about 650 patients, and data to date shows that CCM therapy improves patients’ quality of life and exercise capacity as measured by PeakVO2. Impulse Dynamics has also initiated a large registry (CCM-REG) for evaluation of the long-term survival benefits of the CCM therapy. With the upcoming 2 randomized controlled studies, Impulse Dynamics plans to further add to the level of evidence with the CCM therapy throughout the range of EF up to 45% and NYHA class II-IV symptoms, and to expand the acceptance of CCM therapy as the only device-based treatment currently available with substantial evidence for heart failure patients with narrow QRS that are not at end-stage.
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
Impulse Dynamics Germany GmbH
Breitwiesenstraße 19
70565 Stuttgart
Tel.: +49 711 220456-0
Fax: +49 711 220456-19
CAUTION: Limited by federal law (United States) to Investigational use only.
Recent Comments