FDA Panel Votes in Favor of the Optimizer® System

Orangeburg, New York, December 5, 2018 –Impulse Dynamics announces that the Circulatory System Devices Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of the Optimizer® System for patients with moderate to severe systolic heart failure.

Cardiac Contractility Modulation is the name of a therapy that delivers electrical signals to the heart intended to reduce symptoms and improve exercise tolerance in patients with heart failure, under the trade name CCM™.  Due to Cardiac Contractility Modulation’s potential to provide a therapeutic solution for patients with reduced and moderately reduced left ventricular systolic function and normal QRS duration who currently do not have other device based therapeutic alternatives, the US FDA has designated the Optimizer® a Breakthrough Therapy and was the first such device to go in front of the Advisory Panel.

By a vote of 12 positive and no negative, the Panel concluded that the benefits of the Optimizer System outweigh the risks for the use in patients who meet the proposed criteria. Furthermore, by a vote of 12 positive and 1 negative, the Panel voted that given the totality of evidence, there is reasonable assurance that the device is safe. In addition, the Panel voted 11 to 2 that there is reasonable assurance of the Optimizer® effectiveness. The Panel provided substantial input related to post approval study requirements that would generate additional evidence about the safety and effectiveness in the indicated population.   Impulse Dynamics is committed to working with the FDA to design a robust post approval program.

The Panel’s non-binding recommendation will be considered by the FDA in its ongoing review of  Pre-market Approval (PMA) application for the Optimizer®.

“We appreciate the FDA’s and the Advisory Committee’s recognition that there is a significant need for safe and effective therapies in patients with heart failure with reduced ejection fraction who are not indicated for CRT therapy and have exhausted pharmaceutical options” said Dr. JoAnn Lindenfeld, professor of medicine at Vanderbilt University. “This device provides a viable option for our patients, of which there is currently no treatment available except pharmaceutical and destination therapy.”

“In the context of the FDA’s Breakthrough Therapies Program, this Advisory Panel outcome represents a resounding success for heart failure patients in the US. This new therapy improves the quality of life and functional status of patients with mildly or moderately reduced ejection fractions, endpoints which are of paramount importance to our patients.” said Dr. William Abraham, professor of medicine at The Ohio State University.

“Impulse Dynamics looks forward to continuing our collaboration with the FDA with respect to the Panel’s favorable votes and recommendations for this Breakthrough Therapy.” said Dr. Simos Kedikoglou, Impulse Dynamics’ CEO.  “Today’s decision brings us one step closer to achieving our goal of making our CCMTM therapy available to heart failure patients in the United States.”

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 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 more than 40 other countries around the world.  Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 80 publications in leading medical journals. The Optimizer® is limited to Investigational use in the United States.

About Impulse Dynamics

Impulse Dynamics 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.

Impulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962