Orangeburg, New York, March 31, 2017 — Impulse Dynamics is pleased to announce that it has successfully completed enrollment of the 160 subjects required for its FIX-HF-5C Confirmatory Study. The FIX-HF-5C Study is a prospective, multicenter, randomized study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable Optimizer System in patients with NYHA class III and IV heart failure and an ejection fraction (EF) between 25% and 45%. The study was designed to prospectively confirm the efficacy of CCM in a subgroup of patients with EF between 25% and 45% from the earlier pivotal trial (FIX-HF-5 Study).
“We look forward with great excitement to the results of the FIX-HF-5C study that may establish CCM as a device therapy available in the United States for heart failure patients with narrow QRS,” said Dr. William Abraham, Chair of Impulse Dynamics’ Steering Committee, and Professor of Internal Medicine and Director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center. “CCM has the potential to be a breakthrough therapy for these US patients, who currently have no other options for improvement.”
“I would like to thank everyone involved in the FIX-HF-5C Study for their hard work and dedication to completing the randomization phase of the study. This is a major milestone. We look forward to completing the 24-week follow-up phase of the study and submitting the Pre-Market Approval application to the US FDA later this year,” said Dr. Simos Kedikoglou, Chief Executive Officer at Impulse Dynamics.
About the Optimizer and CCM Therapy
Over 3,000 patients worldwide have already received CCM through the Optimizer device, an innovative therapy designed for patients with a narrow QRS complex. Impulse Dynamics has completed extensive clinical studies, including several randomized controlled trials, published in articles in over 60 leading medical journals. The Optimizer is approved in the United States for investigational use only. An advanced version of the device, the Optimizer Smart, has been successfully launched in Europe where it is available in a growing number of cardiology centers.
About Impulse Dynamics
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 United States, Europe, Asia and Australia. For more information, please visit www.impulse-dynamics.com.
CCM and Optimizer are trademarks of Impulse Dynamics N.V.
Impulse Dynamics, Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962