MARLTON, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today it has received whole-body MRI-conditional approval for the Optimizer® Smart Mini system from the United States Food and Drug Administration (FDA). The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.
“We are pleased to receive approval for this important labeling change reflecting a necessary option for heart failure patients who likely receive multiple surgeries and benefit from the use of MRI imaging in the course of their treatment,” said Jason Spees, CEO of Impulse Dynamics. “This furthers our commitment to supporting the heart failure patients who benefit from important and life-changing CCM therapy with the Optimizer Smart Mini system.”
“Full body MRI capability is part of our promise to deliver an ongoing pace of innovation,” said David Prutchi, Ph.D., Chief Technology Officer, Impulse Dynamics. “This advance will ensure that patients who can benefit from our CCM therapy are able to pursue the option without limiting important future diagnostic options.”
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.
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 internal technology with improved programming and a smaller size designed to make the implant procedure faster and easier for patients and physicians.
Reference
1 Kuschyk J, Falk P, Demming T, et al. Long‐term clinical experience with cardiac contractility modulation therapy delivered by the optimizer smart system. European Journal of Heart Failure. 2021;23(7):1160-1169. doi:10.1002/ejhf.2202
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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 technology 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. More than 9,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be 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.
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. 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.
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