Impulse Dynamics Is Now Among the First US-based Manufacturers of Active Implantable Devices To Receive Certification
Dr. Deborah Morley, Vice President, Regulatory Affairs and Quality Assurance, said, “This very important milestone in the company’s overall development clearly recognizes the tremendous efforts of the Impulse Dynamics team to maintain a state of the art QMS. Certification of the QMS under the MDR allows us to proceed with the development and approval of our new products in accordance with current EU regulations ensuring both safety and performance of devices for their intended clinical application. This allows Impulse to continue on its stated goal to provide CCM therapy to all heart failure patients in need in Europe and other geographies. This is a company-wide achievement, and I am especially proud of the Quality Assurance team who managed all of the activities required to establish compliance with the new regulation.”
The Medical Device Regulation (EU 2017/45) went into effect in May of 2021 for all manufacturers, distributors, and users of medical devices in the EU, replacing the prior Medical Device Directive and Active Implantable Medical Device Directive. In comparison to the previous directives, the MDR requires more stringent documentation of the technical aspects of a medical device, enhanced clinical evidence requirements, detailed documentation of post-market surveillance activities, and a more comprehensive QMS for medical device manufacturers like Impulse Dynamics. As such, most companies selling products in the EU have had to make significant improvements to documentation, technical testing, and clinical evaluation of their medical devices in order to comply with the new MDR. Notably, given the amount of work required, Impulse Dynamics is one of the first manufacturers of an active implantable device to receive QMS certification under the MDR in the United States.
According to Impulse Dynamics’ CEO, Simos Kedikoglou, M.D., “Our ability to achieve certification of our QMS under the MDR affirms Impulse Dynamics’ position at the leading edge of medical device design, development, and manufacturing. This, in turn, allows us to adhere to the most important goal of making the patient our first priority by providing medical devices of the highest quality. MDR certification opens the door for Impulse Dynamics to proceed with its plans for new product development and to launch them without delay.”
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 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.
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 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 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