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# Impulse Dynamics Heart Device OK’d for MRI
- URL: https://www.fdaweb.com/impulse-dynamics-heart-device-okd-for-mri/
- Published: 2023-10-30T12:00:00.000Z
- Updated: 2026-09-14T14:14:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155672

FDA has approved Impulse Dynamics’ Optimizer Smart Mini system for whole-body MRI-conditional use. Impulse Dynamics says the device is used to deliver the company’s proprietary cardiac contractility modulation (CCM) therapy. The approval expands the product labeling to allow for full-body magnetic resonance diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners.

CCM is intended for treating patients with moderate to severe chronic heart failure with symptoms despite optimal medical therapy. “The short and long-term use of this therapy may enhance the strength of ventricular contraction and therefore the heart’s pumping capacity by modulating (adjusting) the myocardial contractility,” the company says.

Treatment, it says, “is delivered by a pacemaker-like device that applies non-excitatory electrical signals (NES), adjusted to and synchronized with the electrical action in the patient’s cardiac cycle. Unlike cardiac pacing, which delivers an electrical signal with the intention to result in cardiac contraction, the cardiac contractility modulation treatment delivers its electrical stimulation during the absolute refractory period and does not cause a cardiac muscle contraction.”