Trial Evaluates FDA-Designated Breakthrough
Therapy for Patients Who Lack Treatment Options
MARLTON, N.J., March 14, 2022 — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced that the first patient has been enrolled in the quadruple-blinded sham-controlled AIM HIGHer IDE clinical study (Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction, NCT: 05064709) evaluating CCM® therapy for patients who have left ventricular ejection fraction ranging between 40% and 60% inclusive. The study will be conducted across approximately 150 centers worldwide.
Simos Kedikoglou, MD, CEO of Impulse Dynamics, said, “AIM HIGHer is another example of our continuous investment in CCM therapy for the benefit of HF patients. Impulse Dynamics is undertaking extensive product and clinical development to bring hope to HF patients worldwide and help them lead more comfortable and productive lives.”
“AIM HIGHer is a remarkable study in several respects,” said Ishu Rao, MD, Medical Director for Impulse Dynamics. “Not only is this the largest randomized sham-controlled therapeutic cardiac device trial to ever be conducted, but it’s studying a label expansion for a new, large, and quite different patient population. These patients have few effective options for treating their condition, and this study is an important step towards offering a solution to this significant unmet medical need.”
HF affects more than 64 million people worldwide and leads to dramatic declines in the quality of life. Patients are often classified by a measure of cardiac function known as the ejection fraction (EF), which describes the percentage of blood pumped out of the left ventricle with each heartbeat. Patients can have HF with severely reduced, moderately reduced, or even preserved ejection fraction (e.g., EF close to the normal range of 60% or above.) Those patients with severely reduced or moderately reduced EF have therapeutic options, including many classes of pharmaceuticals and device therapies such as CCM. However, HF patients with higher EF (e.g., above 40%) have had few therapeutic options thus far to alleviate their symptoms and treat their disease. The purpose of AIM HIGHer is to assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients.
Nareg Minaskeian, PhD, MD, a cardiac electrophysiologist with Southwest Cardiovascular Associates in Mesa, AZ who conducted the first AIM HIGHer implant procedure remarked, “We’re already using CCM therapy for HF patients who have reduced ejection fraction with excellent results, and we have a great deal of hope that CCM will also prove to be effective in patients with a higher EF.”
Javed Butler, MD, MPH, MBA, President of Baylor Scott & White Research Institute, SVP of Baylor Scott & White Health System in Dallas, TX, Distinguished Professor of Medicine at the University of Mississippi and Primary Investigator for the AIM HIGHer trial commented, “It is exciting to have this important trial move from planning to execution phase. This is a high-risk group of patients without many good therapeutic options. CCM therapy is a promising approach to treat these patients, and the AIM HIGHer trial will provide much-needed evidence in this area.”
Dr. Oussama Wazni, Section Chief of Electrophysiology at the Cleveland Clinic and Co-Primary Investigator of AIM HIGHer, was similarly enthused: “We are pleased to begin the AIM HIGHer trial and commend Dr. Nareg Minaskeian on implanting the first device as part of the study. This trial will evaluateCCM therapy in heart failure patients with an EF over 40% — a group that currently has few treatment options.”
The Optimizer delivers cardiac contractility modulation therapy — a proprietary technology of Impulse Dynamics — to the heart. Impulse Dynamics has designed CCM therapy to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. This breakthrough device has demonstrated its capability of enhancing the quality of life for HF patients no longer responding adequately to medication meant to manage their symptoms. CCM therapy is indicated to improve a six-minute hall walk, quality of life, and functional status of NYHA Class III HF patients who remain symptomatic despite guideline-directed medical therapy, who are not indicated for CRT and have a left ventricular ejection fraction ranging from 25% to 45%.
 European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202
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 to improve systolic contraction of the heart. The Optimizer Smart System was granted “Breakthrough Device” designation by the U.S. Food and Drug Administration, and it is the first and only CCM device approved in the U.S. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period, which occurs just after the heart initiates contractions. In doing so, it strengthens and helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, the results of which have been published in over 80 articles appearing in leading medical journals. Studies have shown CCM therapy to sustainably improve 6-minute hall walk distance, quality of life, and functional status among patients who are candidates for the device. The Optimizer Smart has been implanted in over 4,000 patients and is currently available in the U.S., Europe, China, Brazil, India, and more than 40 other countries around the world.
About Impulse Dynamics
Impulse Dynamics, based in Marlton, N.J., is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCM® therapy, which is delivered by the company’s Optimizer system, a breakthrough, FDA-approved treatment verified to improve the quality of life for heart failure patients. CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few alternatives available to them.1 To learn more, visit www.ImpulseDynamics.com, or follow the company on social media at LinkedIn, Twitter, and Facebook.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/
Impulse Dynamics (USA), Inc.
50 Lake Center Executive Park, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933