October 2014 – Impulse Dynamics announced the first enrollment to the IMPULSE-HF European randomized controlled efficacy study in Europe at the Karolinska Institute, Stockholm, Sweden.
“We are very happy to enroll the first patient in the IMPULSE-HF study and we look forward to gain experience with the CCM therapy in Sweden” said Prof. Cecilia Linde from the Karolinska Institute, Stockholm.
“The IMPULSE-HF study is designed to provide additional important evidence related to the clinical benefit of CCM therapy in symptomatic NYHA II-III patients having normal QRS and EF 25-45. The study is well structured and includes an adaptive design and objective endpoints evaluated in double assessment to maximize reliability and power of the results” said Prof. Stefan Anker, the chair of the steering committee of the IMPULSE-HF study. “We look forward to productive enrollment in the variety of participating sites across Europe”.
“Impulse Dynamics has conducted multiple studies with CCM therapy, with 3 randomized controlled trials completed to-date, and is expanding the evidence in a broader range of patient populations with two additional ongoing randomized trials. IMPULSE-HF is an important randomized study in Europe that would provide more data about CCM including in NYHA II and higher EF heart failure population” said Dr. Benny Rousso, VP of Research and Clinical Affairs for Impulse Dynamics. “We are very happy to make this first step into this study, and thankful to Prof. Linde and the team in Karolinska institute for this progress”.
The Optimizer™ IVs is a minimally invasive implantable device designed to treat Chronic Heart Failure (CHF). The device is based on novel Cardiac Contractility Modulation (CCM™) technology, and delivers non-excitatory electric pulses.
The Optimizer™ IVs device delivers the CCM therapy and it has been successfully launched in Europe and is available in cardiology centers in various countries. The CCM therapy 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 vast number of 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.
Impulse Dynamics N.V. 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
Impulse Dynamics Germany GmbH
Tel.: +49 711 220456-0
Fax: +49 711 220456-19