Company Is Committed to Innovation for Patients Living With Heart Failure
MARLTON, N.J., May 10, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), is announcing today the first implants of its newly launched Optimizer® Smart Mini, which delivers the company’s proprietary CCM® therapy. The company announced the launch of its new technology on April 29, and the first procedures with the new commercially-available system were subsequently completed simultaneously by physicians at two different U.S. centers.
“I was able to attend the Heart Rhythm Society’s annual scientific sessions in San Francisco last week and moderated a rhythm theater panel presentation on Impulse Dynamics’ CCM technology,” said Kenneth Ellenbogen, MD, Martha M., and Harold W. Kimmerling, Professor of Cardiology, Chair, Division of Cardiology, and Director of Clinical Cardiac Electrophysiology at the Virginia Commonwealth University Medical Center in Richmond, VA. “I was involved in some of the early research on CCM, and now it’s clear that this therapy has the potential to fill a significant unmet medical need for patients with heart failure.”
“We’re excited to be one of the first institutions to implant this latest generation CCM therapy device,” said Dr. Ameer Kabour, an interventional cardiologist and Director of Cardiology at Mercy Health St.Vincent Medical Center in Toledo, OH. “The Optimizer Smart Mini provides convenience to both providers and many of their patients who suffer from heart failure. These patients may be suffering in spite of being on medications. This device can help relieve many of these patients’ symptoms in the short term, and the diagnostics it provides can help us manage their disease over the long term.”
“In the ambulatory surgical center setting, we strive to make our patients’ experiences as simple, safe, and effective as possible,” said Andrew Kaplan, MD, a clinical cardiac electrophysiologist with Southwest Cardiovascular Associates in Mesa, Arizona. “The reduced size, physiologic shape, and simplified programming that this new generation of device offers can help us meet all of those requirements.” Dr. Kaplan completed his first commercial implant of the Optimizer Smart Mini on May 2, 2022.
The Optimizer Smart Mini incorporates a rechargeable battery with 20-year battery life, offering HF diagnostic monitoring that provides important clinical insights to providers to assist in managing their patients with heart failure. This latest generation also offers new internal technology with improved programming and a smaller size designed to make the implant procedure faster and easier for patients and physicians.
“We are committed to continued innovation by not only including a 20-year battery but by also making this new device 25% smaller and 33% lighter than its predecessor. We announced late last month that over 7,000 patients have now benefitted from our CCM therapy,” said Jason Spees, President and Chief Commercial Officer at Impulse Dynamics. “It is great to know that the millions of patients that could benefit from our CCM therapy worldwide will now get an even better device.”
The Optimizer Smart Mini delivers CCM therapy to the heart. CCM therapy delivers precisely timed electrical pulses to the heart that are intended to improve the heart’s ability to contract, allowing more oxygen-rich blood to be pushed out through the body.[1] CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA (New York Heart Association) Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT(cardiac resynchronization therapy), and have a left ventricular ejection fraction ranging from 25 to 45 percent.
About Impulse Dynamics
Impulse Dynamics, based in Marlton, NJ, 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® Smart Mini, an FDA-approved treatment verified to improve the quality of life for certain heart failure patients. CCM therapy is a safe, effective, and minimally invasive treatment option for many heart failure patients 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.
Forward-looking Statements
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: the potential benefits of our CCM therapy and the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer Smart Mini and our 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: our future research and development costs, capital requirements and our needs for additional financing; commercial success and market acceptance of our proprietary CCM therapy; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Optimizer Smart and Optimizer Smart Mini systems or any future products we may seek to commercialize; competitive companies and technologies in our industry; our ability to expand our indications and develop and commercialize additional products and enhancements to our current products; our business model and strategic plans for our products, technologies and business, including our implementation thereof; our ability to expand, manage and maintain our direct sales and marketing organization; our ability to commercialize or obtain regulatory approvals for our CCM therapy and our 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 our ability to establish and maintain intellectual property protection for our CCM therapy and products or avoid claims of infringement. The forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
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[1] European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202
