MARLTON, NJ, March 14, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced that the first patient was enrolled in the sham-controlled AIM HIGH quadruple-blind program uh Clinical study IDE (Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction, NCT: 05064709 ) evaluating CCM® therapy for patients with a left ventricular ejection fraction between 40% and 60% inclusive. The study will be conducted in approximately 150 centers around the world.
Simos Kedikoglou, MD, CEO of Impulse Dynamics, said, “AIM HIGH uh is another example of our continued investment in CCM therapy for the benefit of heart failure patients. Impulse Dynamics undertakes extensive product development and clinical development to bring hope to IC patients around the world and help them lead more comfortable and productive lives.
“AIM HIGH uh is a remarkable study in several respects,” said Ishu Rao, MD, medical director of Impulse Dynamics. “Not only is this the largest randomized controlled trial of a fictional cardiac therapeutic device ever done, but it investigates an expansion of the label for an important new and quite different patient population. These patients have few effective options to treat their condition, and this study is an important step towards providing a solution to this significant unmet medical need.
HF affects more than 64 million people worldwide and results in a dramatic decline in quality of life. Patients are often classified by a measure of heart function known as the ejection fraction (EF), which describes the percentage of blood pumped out of the left ventricle with each heartbeat. Patients may have an IC with a severely reduced, moderately reduced, or even preserved ejection fraction (eg, EF close to the normal range of 60% or greater). Patients with severely reduced or moderately reduced EF have treatment options, including many classes of pharmaceuticals and device therapies such as CCM. However, heart failure patients with a higher EF (eg, greater than 40%) have so far had few therapeutic options to relieve their symptoms and treat their disease. The purpose of AIM HIGH uh is to assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality in these patients.
Nareg Minaskeian, PhD, MD, cardiac electrophysiologist at Southwest Cardiovascular Associates in Mesa, AZ, who conducted the first AIM HIGH uh implant procedure remarked, “We are already using CCM therapy for patients with IC who have a reduced ejection fraction with excellent results, and we are very hopeful that CCM will improve.” will also prove effective in patients with higher EF.
Javed Butler, MD, MPH, MBA, president of the Baylor Scott & White Research Institute, senior vice president of the Baylor Scott & White Health System in Dallas, TX, professor emeritus of medicine at the University of Mississippi, and principal investigator for the AIM HIGH uh trial commented, “It is exciting to see this important trial move from the planning phase into the execution phase. This is a high-risk group of patients without many good treatment options. CCM therapy is a promising approach to treating these patients, and the AIM HIGH program uh the trial will provide much-needed evidence in this area.
Dr. Oussama Wazni, Section Chief of Electrophysiology at Cleveland Clinic and Co-Principal Investigator of AIM HIGH uhwas equally enthusiastic: “We are thrilled to launch the AIM HIGH uh trial and congratulate Dr. Nareg Minaskeian for implanting the first device in the study. This trial will evaluate CCM therapy in heart failure patients with an EF greater than 40% – a group that currently has few treatment options. »
The Optimizer delivers cardiac contractility modulation therapy – an exclusive Impulse Dynamics technology – to the heart. Impulse Dynamics designed CCM Therapy to significantly improve cardiac contraction, allowing more oxygen-rich blood to be expelled through the body.  This revolutionary device has demonstrated its ability to improve the quality of life of patients with HF who no longer respond adequately to medications intended to manage their symptoms.  CCM therapy is indicated to improve a six-minute walk down the hall, quality of life, and functional status of patients with NYHA Class III HF who remain symptomatic despite medical treatment according to guidelines, who are not indicated for CRT and who have a left ventricular ejection fraction ranging from 25% to 45%.
About impulse dynamics
Impulse Dynamics, based in Marlton, NJ, is dedicated to helping healthcare providers improve the lives of people with IC by transforming the way the disease is treated. The company pioneered CCM therapy, which is delivered by the company’s Optimizer® system, a revolutionary treatment approved by the FDA and verified to improve the quality of life of patients with heart failure. CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few effective options available to them. To visit www.ImpulseDynamics.comor follow the company on LinkedIn, Twitterand Facebook to learn more.
 European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202
Rex Richmond (Media Relations) Impulse Dynamics 856-642-9933 [email protected] Harriss Currie (Investor Relations) Impulse Dynamics 856-642-9933 [email protected] Ian Segal (Public Relations) Impulse Dynamics 856- 642-9933 [email protected]
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