The expanded 510(k) clearance from the FDA for the Optimizer Smart Mini system allows full-body MRI use for patients with heart failure who are receiving cardiac contractility modulation (CCM).
The Food and Drug Administration (FDA) has approved a 510(k) conditional clearance for whole-body magnetic resonance imaging (MRI) use in heart failure patients receiving proprietary cardiac contractility modulation (CCM) therapy with the Optimizer Smart Mini device (Impulse Dynamics).
The expanded labeling includes the use of 1.5 and 3.0 Tesla (T) full-body MRI with the Optimizer Smart Mini system, an implantable device that employs electrical pulses to facilitate heart contraction in patients with New York Heart Association (NYHA) Class III heart failure, according to Impulse Dynamics.
The company noted the Optimizer Smart Mini system was previously cleared by the FDA to improve six-minute hall walk and quality of life for those with a left ventricular ejection fraction between 25 to 45 percent and continue to experience symptoms despite receiving guideline-directed medical treatment.
Impulse Dynamics said the expanded indication for conditional MRI use is a significant benefit in this patient population.
“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,” noted Jason Spees, the 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.”