MARLTON, N.J., June 14, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a commercial-stage medical device company focused on delivering our CCM therapy to people with heart failure, announced that the first implants in Europe for the newly launched Optimizer® Smart Mini device were recently completed in Italy. The company announced the launch of the new technology on April 29, 2022, and the first U.S. implants on May 10, 2022.
Dr. Stefano Guarracini, Head of Cardiology at the Synergo Casa di Cura Pierangeli Hospital in Pescara, Italy, described his experience with CCM therapy and his outlook for the Optimizer Smart Mini system after the first implant. “Starting in 2019, we had the opportunity to implant Optimizer devices in several patients with heart failure. We believe in the technology and consider CCM therapy to be the only option for many patients suffering from heart failure. We are excited now to be affiliated with the first European institution to have implanted the new Optimizer Smart Mini device and look forward to the simple but more advanced patient management experiences during implants and follow-ups going forward.”
Dr. Giovani Bisignani, with the Ospedale di Castrovillari, who completed his first implant almost simultaneously in the southern Italian province of Cosenza, said, “CCM therapy is a powerful weapon against heart failure. The cutting-edge technology of the new Optimizer Smart Mini along with its smaller, physiological shape allowed us to achieve efficient implantation and initiation of CCM therapy in even less time.”
In March 2022, the company announced that its quality management system received certification under the new European Union Medical Device Regulation. We believe that the launch of the Optimizer Smart Mini system is an example of the importance of a global infrastructure to support ongoing technology innovation and access. The new components of the Optimizer Smart Mini system are equally important across international markets, including a rechargeable battery with a 20-year life and new internal technology with improved programming and potential for remote monitoring in a smaller design to make the implant procedure easier for patients and physicians.
“The pace of this international rollout is a reflection of our commitment to delivering innovation that is relevant to patients worldwide,” said Mateusz Zelewski, MD, Impulse Dynamics’ Vice President International, “It is exciting to see how quickly we can increase access to new and better technology that offers hope for more patients living with heart failure.”
The Optimizer Smart Mini delivers CCM therapy, which consists of electric pulses applied to the heart between heartbeats and serves to enhance the performance of cardiac muscular contraction, making the heart work more efficiently without increasing the heart rate or the oxygen consumption of the cardiac muscle. CCM therapy is currently indicated in Europe to reduce hospitalizations and improve physical exercise tolerance, quality of life, and functional status for a large population of patients with systolic heart failure who remain symptomatic despite guideline-directed medical therapy.
To date, CCM therapy has already been used to treat over 7,000 patients worldwide and is available in 44 countries across the globe. The therapy has been studied in almost 2,000 patients and has appeared in more than 100 peer-reviewed journal articles. Ongoing studies are also underway to examine the safety and efficacy of CCM for patients suffering from heart failure with a left ventricular ejection fraction between 40 – 60%.
About Impulse Dynamics
Impulse Dynamics is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company is focused on delivering its proprietary CCM therapy, which is delivered by the company’s Optimizer Smart device, the CE-marked, and FDA-approved treatment verified to improve the quality of life for 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.[1] 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 potential benefits of CCM therapy, and the absence of risks associated therewith; 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 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; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for Optimizer Smart and Optimizer Smart Mini 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.
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[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/
