MARLTON, N.J., Oct 31 (Bernama-GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today it has received whole-body MRI-conditional approval for the Optimizer® Smart Mini system from the United States Food and Drug Administration (FDA). The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.
“We are pleased to receive approval for this important labeling change reflecting a necessary option for heart failure patients who likely receive multiple surgeries and benefit from the use of MRI imaging in the course of their treatment,” said Jason Spees, CEO of Impulse Dynamics. “This furthers our commitment to supporting the heart failure patients who benefit from important and life-changing CCM therapy with the Optimizer Smart Mini system.”