GLOBAL REGULATORY ORGANIZATION CERTIFIES OPTIMIZER SMART DEVICE
AS COMPLIANT FOR WHOLE-BODY MRI SCANS IN THE EU
Impulse Dynamics Receives Medical Device Approval for European Union to Safely Administer MRI Scans for Heart Failure Patients with Implanted Optimizer Smart Devices
MARLTON, N.J., February 16, 2021 — Impulse Dynamics, an international medical device company dedicated to improving the lives of people with heart failure (HF), today announced that DEKRA Certification B.V. (DEKRA), a global regulatory organization, approved labeling for the Optimizer® Smart device for conditional full-body MRI scans utilizing 1.5 Tesla scanners in the EU. DEKRA, known for ensuring the safe use of medical devices in global markets, has given HF patients with the Optimizer Smart device implant the opportunity to receive whole-body magnetic resonance imaging required to diagnose anatomical and physiological processes.
The commercial significance of this accomplishment affords not only HF patients with peace of mind but healthcare practitioners with unhindered access to perform full-body MRI scans. Additionally, the Optimizer’s safe use approval opens the door to extensive use with other MRI-conditional devices. “The MRI full-body certification by DEKRA is a significant step for Impulse Dynamics. This gives patients and physicians the assurance that important diagnostic examinations can be performed for the benefit of patients, independent of the CCM® therapy,” Jens Kalender, Vice President of Commercial DACH for Impulse Dynamics, said today.
Additionally, as noted by Deborah Morley, Ph.D., Vice President of Regulatory Affairs and Quality Assurance, “Attainment of whole-body MRI-conditional CE labeling is a major milestone for Impulse Dynamics made possible through positive cooperation with the notified body, DEKRA, and our top-notch engineering team. We look forward to many more such achievements in the near future, advancing CCM therapy to provide hope for heart failure patients worldwide.”
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
2 Mozzafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and
Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart
Association. Circulation. 2016; 133:e38-e360.
3 Abraham 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).