FDA Authorizes Removal of “NSR” From Indications for Use
“We applaud the FDA’s decision based on clinical evidence provided to remove the previous barrier to CCM therapy concerned with heart rhythm, opening it up to additional patients in need,” said Jason Spees, President and Chief Commercial Officer of Impulse Dynamics. “This decision removes what had been a significant barrier for efficient and effective clinical decision making in the best interest of hundreds of thousands of patients.” Impulse Dynamics estimates the current addressable market for CCM therapy in the U.S. alone to be over 1.1 million patients.[1]
Since introducing the two-lead configuration of the Optimizer Smart in 2019, the device’s design has been capable of supporting patients with heart rhythms other than NSR; however, the inclusion of such patients has been prohibited by the approved labeling in the U.S. until today. In the EU, patients not in NSR, including those with atrial fibrillation (A-fib), have been widely treated with CCM therapy with excellent outcomes since 2016. Additionally, the FDA’s decision was based on the submission of data from a long-term clinical study led by Dr. Jürgen Kuschyk in 2021.[2] The study, comprised of a registry featuring 503 patients in the EU, compared the outcomes of those with A-fib treated with CCM therapy to a cohort treated with CCM that did not have A-fib. Both groups exhibited positive results, and no safety issues related to heart rhythm were identified. Today’s announcement of FDA approval of a simple modification of the labeling to remove “NSR” from the Optimizer’s indications for use has significantly expanded the market for CCM therapy to patients with many different heart rhythms, including A-fib.
When informed about the FDA’s approval regarding the removal of NSR, Dr. George Mark, a clinical cardiac electrophysiologist with The Heart House in Marlton, N.J., stated that “CCM is an important therapeutic option appropriate for patients who manifest lifestyle limiting symptoms despite guideline-directed medical therapy (GDMT) for congestive heart failure (CHF). Many of these same patients also suffer from atrial arrhythmias like atrial fibrillation and flutter, which has, up until now, prevented the timely use of CCM. Access to CCM therapy would often be delayed to assess atrial fibrillation burden further, provide opportunities to restore sinus rhythm or titrate medication. Previously, the presence of A-fib presented, at the very least, a mental barrier for clinicians and sometimes eliminated CCM from consideration. This welcomed change to the labeling will simplify the process of assessing suitable candidates for CCM therapy, and for many, will shorten the amount of time required to receive treatment.”
[1] This estimate is based on the current CCM therapy indications, which include patients diagnosed with NYHA Class III HF, who remain symptomatic despite guideline-directed medical therapy, and who are not indicated for cardiac resynchronization therapy.
[2] European Journal of Heart Failure, https://doi.org/10.1002/ejhf.2202
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 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 receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.
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.
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.
Impulse Dynamics (USA), Inc.
50 Lake Center Executive Park, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933
www.impulse‐dynamics.com
PUBLIC RELATIONS:
Hilary Schlimbach
Sr. Manager, Marketing Communications
Impulse Dynamics
isegal@impulsedynamics.com
856-642-9933
MARKETING OPERATIONS:
Rohan More
Global Vice President, Marketing
Impulse Dynamics
rmore@impulsedynamics.com
856-642-9933
