Clinical Registry Data and recently published FIX-HF-5C were presented at the Late-Breaking Clinical Trial Session at EHF 2018
Stuttgart, Germany, May 28th, 2018 – Impulse Dynamics Germany, GmbH announced results on “Real World” experience from its European Clinical Registry. The results were presented today by Prof. Gerd Hasenfuß, MD, Professor of Internal Medicine and Director of the Heart Center, University Hospital Göttingen, Germany at the Late-Breaking Clinical Trials Session of the European Heart Failure Congress in Vienna, Austria.
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 (HF). 140 of the patients enrolled in the observational registry in Europe had characteristics similar to those of the patients enrolled in the recently finished US FIX-HF-5C study: QRS <130 msec, ejection fraction (EF) between 25% and 45% and NYHA class III or IV HF. Enrollment occurred based on clinical need and all data was independently monitored. The patients in the registry were followed for up to 2 years for hospitalizations, Minnesota Living with Heart Failure Questionnaire (MLWHFQ), and NYHA, and followed up to 3 years for mortality. Reported mortality was compared with that predicted by the Seattle Heart Failure Model (SHFM) and the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC). A separate analysis was performed on the subgroup of patients with EF between 25-34% and 35-45%.
Highlights of the CCM-Registry results include:
- In real-world experience, CCM™ produces results similar to those of previous studies in subjects with LVEF 25-45% and QRS<130ms
- Hospitalizations decreased by 75% in the 2-years following CCM™ compared to the 1-year period prior to CCM™
- MLWHFQ and NYHA showed significant and progressive improvement over 2-years.
- Clinical effectiveness was even greater in patients with EF 35-45%. This subgroup of patients showed a greater benefit in performance improvement and a statistically significant reduction in mortality compared to mortality prediction models
“The results of the Registry and the FIX-HF-5C exceeded my expectations. The “Real World Evidence” of the registry data is consistent with that from the randomized controlled study data from the FIX-HF-5C. The benefits for patients such as improved exercise capacity and quality of life, but also the effects on heart failure morbidity and mortality are impressive and confirm CCM as a valuable treatment option for patients suffering from heart failure” said Prof. Hasenfuß. “It provides a therapy option for patients with moderately reduced left ventricular systolic function (EF25-45%), who currently have no other options for improvement.”
“I would like to thank the Registry Investigators and the Impulse Dynamics’ team for completing this important Registry confirming the Fix-5C randomized study and providing an option for heart failure patients with narrow QRS.” said Dr. Simos Kedikoglou, Impulse Dynamics’ CEO.
About the Optimizer and CCM Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart’s cardiac cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 4,000 patients and is currently available in the US, Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and the results have been published in over 80 articles appearing in leading medical journals.
About Impulse Dynamics
Impulse Dynamics is a medical device company dedicated to transforming the treatment of chronic heart failure. With global headquarters in Mount Laurel, N.J., the company has additional offices in; Stuttgart, Germany, Orangeburg, N.Y. and Curacao For more information please visit www.impulse-dynamics.com.
Impulse Dynamics (USA), Inc.
523 Fellowship Road, Suite 203
Mt. Laurel, NJ 08054