Stuttgart, Germany, October 22nd 2018 – The first patient was enrolled in Impulse Dynamics’ international multi-center clinical trial testing the efficacy and safety of its CCM™ technology in heart failure patients with preserved Ejection Fraction (CCM™-HFpEF).
Cardiac contractility modulation is an established device based therapy shown in several international multicenter randomized controlled trials to be an effective treatment option for patients with Chronic Heart Failure with reduced Ejection fraction (HFrEF) and narrow QRS complex.
Karolinska University Hospital in Sweden is the first participating center to enroll a patient in this European international pilot study (https://clinicaltrials.gov/ct2/show/NCT03240237) Impulse Dynamics would like to congratulate Professor Cecilia Linde and research nurse Helena Karlsson for their great work in finding the first suitable patient and also Dr Fredrik Gadler and his skilled implantation team for taking this first important step to learn more about effective treatment of the large group of underserved heart failure patients with preserved ejection fraction.
CCM™ is the brand name for the nonexcitatory electrical pulses delivered by the implantable Optimizer® device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer® system has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India and several other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 70 publications in leading medical journals. The Optimizer® 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 United States, Europe, and Asia. For more information please visit www.impulse-dynamics.com.
CCM and Optimizer are trademarks of Impulse Dynamics N.V.
For EU release only, device for investigational use only in US