IMPULSE DYNAMICS ANNOUNCES FDA APPROVAL FOR MAGNETIC
FDA Clears Potential Hurdle for Many Heart Failure Patients
MARLTON, N.J., January 20, 2021 — Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval represents a significant advance because the population that benefits most from cardiac contractility modulation therapy (patients with moderate to severe HF) often requires advanced diagnostic imaging procedures.
“It’s important that Impulse Dynamics acted quickly in a joint effort with FDA to remove this potential barrier standing in the way of critical diagnostic procedures for a subset of patients with HF. This technology has received a lot of attention in our facility, and, likely, many of the patients who need and then receive CCM therapy will ultimately require MRI procedures,” said Dr. Robert W. W. Biederman, Director of Cardiovascular Imaging and Cardiac MRI at Allegheny General Hospital/Allegheny Health System in Pittsburgh and an author on the groundbreaking 2017 MagnaSafe trial published in NEJM. “Certainly, other imaging modalities are available, but MRI is the gold standard in terms of image quality, especially for neurovascular imaging. Typically, MRI is preferred by imaging specialists because it’s the safest alternative for most patients. Further, combined with the early successes in improving cardiac performance, now when combined with MRI compatibility, CCM adds to the armamentarium of the cardiologist and electrophysiologist in further optimizing FDA-approved medical therapies in 2021.”
The Optimizer device, similar in size to a pacemaker, is implanted during a minimally invasive procedure while the patient is under light sedation. The device provides CCM therapy, consisting of precisely timed electrical pulses delivered to the heart during the absolute refractory period of the beating cycle, just after the heart contracts. It has been used to treat over 5,000 patients and is currently available in the United States, Europe, China, Brazil, India, and over 40 other countries worldwide. This US approval complements previous MR-conditional approvals in geographies outside of the US. Providers are encouraged to reference the package insert related to MRI safety for specific details regarding implant conditions and scanning procedures in their respective geographies.
“We appreciate the FDA’s open and willing collaboration on this submission and the approval process,” said Dr. David Prutchi, Executive Vice President and Chief Technology Officer at Impulse Dynamics. “Our goal was to prove that patients implanted with CCM delivery devices could safely undergo MRI scans of the head and limbs using local RF transmit-receive coils. With that objective met, we will continue to press forward in our efforts to advance CCM therapy with additional clinically meaningful improvements.”
About the Optimizer and CCM Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device to improve systolic contraction of the heart. The Optimizer Smart System was granted Breakthrough Device designation by the U.S. Food and Drug Administration, and it is the first and only CCM device approved in the U.S. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period, which occurs just after the heart initiates contractions. In doing so, it strengthens and helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, the results of which have been published in over 80 articles appearing in leading medical journals. Studies have shown CCM therapy to sustainably improve 6-minute hall walk distance, quality of life and functional status among patients who are candidates for the device. The Optimizer Smart has been implanted in over 4,000 patients and is currently available in the U.S., Europe, China, Brazil, India and more than 40 other countries around the world.
About Impulse Dynamics
Impulse Dynamics, based in Marlton, N.J., is dedicated to helping healthcare providers improve the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCM® therapy, which is delivered by the company’s Optimizer® system, a breakthrough, FDA-approved treatment that is proven to improve the quality of life for heart failure patients.1 CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few effective options available to them.1 To learn more visit www.impulse-dynamics.com, or follow the company on LinkedIn and Twitter.
Impulse Dynamics (USA), Inc.
50 Lake Center Executive Parkway, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933