ORANGEBURG, New York, May 10, 2018 /PRNewswire/ --
Impulse Dynamics (USA), Inc.
CCM™ is a therapy unique to the Optimizer® family of devices that deliver electrical signals to the heart that are intended to reduce symptoms and improve exercise tolerance in patients with heart failure. The FIX-HF-5C study was designed to prospectively confirm a subgroup analysis of the prior FIX-HF-5 pivotal trial, showing that CCM™ significantly improved exercise tolerance and quality of life in patients with NYHA class III and IV heart failure symptoms, ejection fraction 25-45%, and a QRS <130ms. A Bayesian statistical analysis plan was developed to combine the data already available from the original FIX-HF-5 study with the FIX-HF-5C study data. The results presented today at HRS supplement and confirm the results from the prior study, meeting the safety and effectiveness objectives of the study.
Highlights of the results include:
- CCM™ is safe; the study met its primary and secondary safety endpoints.
- Patients receiving CCM™ showed significantly better exercise tolerance and quality of life compared to their control-group counterparts.
- The composite of cardiovascular deaths and heart failure hospitalizations was statistically significantly reduced in comparison to the control group.
- Clinical effectiveness was even greater in patients with EF >35%.
"The results of the FIX-HF-5C study exceeded my expectations by not only confirming the benefits of CCM™ on important patient-centered endpoints such as exercise capacity and quality of life, but also in demonstrating the potential for CCM™ to reduce heart failure morbidity and mortality" said Prof. Abraham. "These findings support the use of CCM™ as a breakthrough therapy for heart failure patients with moderately reduced left ventricular systolic function and narrow QRS durations, who currently have no other options for improvement."
"I would like to thank the FIX-HF-5C Study Investigators and the Impulse Dynamics' team for completing this important study with its very encouraging results." said Dr. Simos Kedikoglou, Impulse Dynamics' CEO. "We anticipate submission of the final PMA module to the U.S. FDA in June 2018."
About the Optimizer® and CCM™ Therapy
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.
About Impulse Dynamics
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 http://www.impulse-dynamics.com.
Impulse Dynamics (USA), Inc. 30 Ramland Road South, Suite 204 Orangeburg, NY 10962
Contact: Sharon Alon Tel: +1-347-761-3342
SOURCE Impulse Dynamics
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