Post-Approval Study will evaluate real-world safety and efficacy evidence for breakthrough heart failure therapy
MOUNT LAUREL, N.J. – March 17, 2020 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.
Impulse Dynamics Announces First Enrollment in Post-Approval Study of CCM Therapy Delivered by the Optimizer System. Post-Approval Study will evaluate real-world safety and efficacy.
“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 the Optimizer® and CCM® Therapy
The Optimizer Smart system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve the 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.
CCM is the brand name for cardiac contractility modulation — the non-excitatory electrical pulses delivered by the implantable Optimizer device to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period. In doing so, CCM helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and CCM therapy has been published in more than 120 peer-reviewed journal articles.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM therapy, which uses the Optimizer platform to improve quality of life in heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. CCM therapy has proven safe and effective for heart failure patients with debilitating symptoms who otherwise have few effective options available to them. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, Twitter, and Facebook.
This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning potential benefits of CCM therapy, the continued momentum for the adoption of CCM therapy and use of the Optimizer Smart system globally; the ability for CCM therapy and our products and technology to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer system and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release include, without limitation: the company’s future research and development costs, capital requirements and the company’s needs for additional financing; company’s ability to expand and grow its business into new geographic markets; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for its Optimizer systems or any future products the company may seek to commercialize; competitive companies and technologies in the industry; the company’s ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the company’s business model and strategic plans for its products, technologies and business, including its implementation thereof; the company’s ability to expand, manage and maintain its direct sales and marketing organization; the company’s ability to commercialize or obtain regulatory approvals for CCM therapy and its products, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; and the company’s ability to establish and maintain intellectual property protection for CCM therapy and products or avoid claims of infringement. The company does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
Impulse Dynamics (USA), Inc.
50 Lake Center Executive Park, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933
Global Vice President, Marketing
Manager, Public Relations
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