Post-Approval Study will evaluate real-world safety and efficacy evidence for breakthrough heart failure therapy
MT. LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced the first enrollment in a post-approval study of its innovative CCM™ therapy delivered by the Optimizer® system.
The Optimizer Post-Approval Study, a prospective, multi-center, single-arm study, will evaluate the real-world evidence of the therapy’s safety and efficacy. The first patient was enrolled by Charles Jost, M.D., interventional cardiologist and principal investigator at Southwest Cardiovascular Associates in Mesa, Ariz.
“Before the Optimizer system was introduced, many of my heart failure patients had few, or no effective options to improve their quality of life available to them,” said Dr. Jost. “The positive clinical outcomes for patients treated with this therapy are impressive and it has given many of my patients a reason to be hopeful again. I am pleased to participate in this study because it seeks to further substantiate the compelling portfolio of clinical evidence that supported the Optimizer system’s FDA approval in actual clinical practice over time.”
The study will evaluate the safety and efficacy of the Optimizer system over three years and will enroll up to 620 patients from heart centers across the United States. Efficacy endpoints include improvements in quality of life (MLWHFQ), New York Heart Assn. (NYHA) classification, left ventricular ejection fraction and end-systolic volume. Safety endpoints include device- or procedure-related complications, and an assessment of all-cause mortality.
“The Optimizer is a breakthrough heart failure treatment and we are highly encouraged by the significant attention it has received from patients, providers and payors following its FDA approval,” said Ishu Rao, M.D., Medical Director for Impulse Dynamics. “Enrolling the first patient in this study is an important step towards our goal of strengthening our world-wide clinical portfolio of evidence that validates the benefits of CCM therapy which has already been delivered to thousands of heart failure patients worldwide.”
CCM therapy, delivered by the Optimizer system, is a breakthrough approach to treating heart failure that is proven to improve quality of life for suitable patients.1 The innovative therapy is the first of its kind designed to improve contraction of the heart, allowing more oxygen-rich blood to reach the body.1 CCM therapy delivers precisely timed electrical pulses to the heart during the absolute refractory period of the beating cycle, just after the heart contracts. The Optimizer system was granted Breakthrough Device designation by the FDA and is the first and only FDA-approved device in the U.S. or elsewhere for the delivery of CCM therapy.
CCM therapy may be an appropriate treatment option for the approximately 70 percent of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy.1
About Heart Failure
Heart failure, a condition in which the heart slowly weakens and is not able to adequately supply oxygen-rich blood, affects an estimated 6.5 million Americans and nearly 26 million people worldwide.2 By 2030, it is expected to affect 8 million Americans.3 Heart failure patients experience debilitating symptoms, including breathlessness, fatigue, confusion and swelling in the legs that make everyday activities challenging and significantly diminish their quality of life. Nearly 50 percent of people with heart failure die within five years of being diagnosed.3 The annual cost for healthcare services, medications and lost working days in the US is estimated to reach $70 billion by 2030.3
About Impulse Dynamics
Impulse Dynamics, based in Mount Laurel, N.J., is dedicated to improving the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCMTM therapy (cardiac contractility modulation), which is delivered by the company’s Optimizer® system, a breakthrough, FDA-approved treatment that is proven to improve the quality of life for heart failure patients.1 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.1 To learn more visit www.impulse-dynamics.com, or follow the company on LinkedIn and Twitter.
1 Abraham WT, Kuck KH, Goldsmith RL, et al. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation. JACC Heart Failure. 6(10), 874-883 (2018).
2 Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr; 3(1): 7–11.
3 Benjamin E, Blaha M, Chiuve S, et al. Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association. Circulation. 2017;135:e146–e60