MARLTON, N.J., May 18, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced the completion of the first implantation for the INTEGRA–D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined "" CCM and an implantable cardioverter defibrillator (ICD) "" in a single device (CCM–D). The Optimizer IntegraTM CCM–D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life–threatening arrhythmias that may cause sudden cardiac death. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.
The journey of a heart failure patient often involves debilitating symptoms and declining quality of life.
CCM therapy delivered by the Optimizer System improves quality of life and helps patients feel better. Patients indicated for CCM therapy may also be at a higher risk for arrythmias and sudden cardiac arrest and are therefore often offered an ICD to treat their heart for life–threatening arrythmias, should they occur. The INTEGRA–D trial is the first to evaluate the Optimizer Integra CCM–D System that combines both therapies into a single device, designed to last for many years.
"The first–in–the–world implant of this novel technology has potential to advance treatments for patients living with heart failure," said Niraj Varma, M.D., Ph.D., electrophysiologist at Cleveland Clinic and National Primary Investigator of the INTEGRA–D clinical trial. "The trial aims to study whether this device can protect heart failure patients from the risk of sudden cardiac death while also treating heart failure symptoms."
"We hope combining cardiac contractility modulation therapy and ICD therapy with prolonged battery life will reduce the number of leads and the number of procedures a patient may have to endure," said Bruce Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic and Principal Investigator of the INTEGRA–D trial. "The first implant went well, and we look forward to further studying this device."
The INTEGRA–D trial is a multicenter study of 300 subjects from 75 centers that will evaluate the combination of CCM and ICD therapy in a single device via the Optimizer Integra CCM–D System. The study will assess the performance of the CCM–D device in effectively treating episodes of ventricular tachycardia and/or ventricular fibrillation while also providing CCM treatment for heart failure. Patients enrolled in the study will receive the Optimizer Integra CCM–D System, and will be followed for at least two years.
"This clinical study is important in proving the potential benefit of combining CCM therapy, which improves quality of life in patients with heart failure, with gold–standard ICD technology that delivers lifesaving therapy for sudden cardiac death," said Nir Uriel, M.D., Director of Advanced Heart Failure and Cardiac Transplantation at New York–Presbyterian and National Co–Principal Investigator for the INTEGRA–D trial. Dr. Uriel is also a professor of cardiology at Columbia University Vagelos College of Physicians and Surgeons and an Adjunct Professor of Medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine.
"Today's announcement is another example of our commitment to a continuous pace of innovation to build a comprehensive platform in interventional heart failure and help improve the lives of many patients that suffer from this debilitating disease," said Simos Kedikoglou, M.D., Chief Executive Officer of Impulse Dynamics. "We are proud to partner with physicians at leading centers around the world to conduct important research on this first–of–its–kind rechargeable combination device designed to address a major unmet need of a large patient group."
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. "Investigational" means that the study device is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA).
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 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 "" a therapy that delivers non–excitatory electrical pulses from 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 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, 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.
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