Impulse Dynamics Receives Medical Device Approval for European Union to Safely Administer MRI Scans for Heart Failure Patients with Implanted Optimizer Smart Devices
MARLTON, N.J., February 16, 2021 — Impulse Dynamics, an international medical device company dedicated to improving the lives of people with heart failure (HF), today announced that DEKRA Certification B.V. (DEKRA), a global regulatory organization, approved labeling for the Optimizer® Smart device for conditional full-body MRI scans utilizing 1.5 Tesla scanners in the EU. DEKRA, known for ensuring the safe use of medical devices in global markets, has given HF patients with the Optimizer Smart device implant the opportunity to receive whole-body magnetic resonance imaging required to diagnose anatomical and physiological processes.
The commercial significance of this accomplishment affords not only HF patients with peace of mind but healthcare practitioners with unhindered access to perform full-body MRI scans. Additionally, the Optimizer’s safe use approval opens the door to extensive use with other MRI-conditional devices. “The MRI full-body certification by DEKRA is a significant step for Impulse Dynamics. This gives patients and physicians the assurance that important diagnostic examinations can be performed for the benefit of patients, independent of the CCM® therapy,” Jens Kalender, Vice President of Commercial DACH for Impulse Dynamics, said today.
Additionally, as noted by Deborah Morley, Ph.D., Vice President of Regulatory Affairs and Quality Assurance, “Attainment of whole-body MRI-conditional CE labeling is a major milestone for Impulse Dynamics made possible through positive cooperation with the notified body, DEKRA, and our top-notch engineering team. We look forward to many more such achievements in the near future, advancing CCM therapy to provide hope for heart failure patients worldwide.”
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
2 Mozzafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and
Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart
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3 Abraham WT, Kuck KH, Goldsmith RL, et al. A randomized controlled trial to evaluate the safety and efficacy of
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