Availability of the two-lead device represents a significant advancement in the development of cardiac contractility modulation therapy for patients with heart failure
MT. LAUREL, N.J.– April 14, 2020 – Impulse Dynamics, a medical device company dedicated to improving the lives of heart failure patients, today announced the publication of the FIX-HF-5C2 study in Circulation: Heart Failure. The study affirms the safety and efficacy of the company’s 2-lead version of the Optimizer® system, which was approved by the FDA in October 2019.
The prospective, multicenter, single-arm study was designed to evaluate the performance, safety and efficacy of the 2-lead Optimizer system. The study confirmed the 2-lead version of the device is just as effective at delivering CCM™ (cardiac contractility modulation) therapy as the 3-lead version and by eliminating the atrial lead, patients experienced significantly fewer device-related complications when compared to the 3-lead version. Patients that received the 2-lead version had a significantly greater improvement in exercise capacity (as measured by peak VO2) and functional status (as measured by New York Heart Association functional class) when compared to the FIX-HF-5C control group. Additionally, 15% of the patients enrolled in the FIX-HF-5C2 study had atrial fibrillation.
“The publication of this data confirms that the 2-lead device is a significant advancement for how we can provide CCM therapy to heart failure patients,” said Ishu Rao, M.D., Medical Director for Impulse Dynamics. “Notably, the data shows that CCM therapy has a substantial positive impact on a patient’s functional capacity over time versus standard medical care alone. There has been tremendous excitement from patients and providers for the 2-lead Optimizer system and we look forward to continuing to expand the adoption of this breakthrough treatment option.”
The FIX-HF-5C2 study was a confirmatory extension of the FIX-HF-5C randomized study and enrolled heart failure patients from eight medical centers in the U.S. and Germany. Patients were evaluated at baseline and again at 12 and 24 weeks after implantation.
“The 2-lead version of the Optimizer system is an important evolution that reduces lead-related complications and simplifies the implantation procedure,” said Phi Wiegn, M.D., of the Dallas VA Medical Center and lead author of the publication. “CCM is a truly unique device therapy that I can offer to a large group of heart failure patients to make them feel better when standard medical therapy no longer does.”
CCM therapy may be an appropriate treatment option for the approximately 70 percent of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy..1
About the Optimizer® Integra CCM-D™ System and CCM® Therapy
The Optimizer Integra CCM-D System is an investigational device that combines CCM therapy and ICD therapy into one device. This device is being used in an FDA-approved Investigational Device Exemption (IDE) study and is not available for sale in the United States.
Impulse Dynamics currently offers the Optimizer system that is FDA-approved and CE-marked. The Optimizer system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to 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 therapy delivers non-excitatory electrical pulses from the implantable Optimizer device in a manner designed to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during their absolute refractory period. 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 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.
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 CCM therapy combined with an ICD delivered via a single device (CCM-D), 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 Integra CCM-D 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; 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
1Abraham WT, Kuck KH, Goldsmith RL, et al. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation. JACC Heart Failure. 6(10), 874-883 (2018).
2Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr; 3(1): 7–11.
3Benjamin E, Blaha M, Chiuve S, et al. Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association. Circulation. 2017;135:e146–e603