Impulse Dynamics Optimizer Smart device is an implantable device that helps optimize cardiac pumping action in heart failure patients.
March 3, 2021 — Impulse Dynamics recently announced that DEKRA Certification B.V., a global regulatory organization, approved labeling for the Optimizer Smart device for conditional full-body magnetic resonance imaging (MRI) scans utilizing 1.5 Tesla scanners in the European Union (EU). DEKRA, known for ensuring the safe use of medical devices in global markets, has given heart failure (HF) patients with the Optimizer Smart device implant the opportunity to receive whole-body MRI 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,” said Jens Kalender, vice president of commercial DACH for Impulse Dynamics.
Additionally, Deborah Morley, Ph.D., vice president of regulatory affairs and quality assurance exoplained, “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.”
For more information: www.impulse-dynamics.com