KUALA LUMPUR, Global medical device company Impulse Dynamics, announced it has received whole-body MRI-conditional approval for the Optimizer Smart Mini system from the United States Food and Drug Administration (US FDA).
According to Impulse Dynamics in a statement, this conditional approval expands the product labelling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners.
The Optimizer Smart Mini system delivers the company’s proprietary cardiac contractility modulation (CCM) therapy and the approval for use with full-body MRI covering new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.
“We are pleased to receive approval for this important labelling 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.
“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,” said Impulse Dynamics Chief Executive Officer, Jason Spees.
The Optimizer Smart Mini delivers CCM therapy to the heart, while CCM therapy delivers precisely timed electrical pulses to the heart that are intended to improve the heart’s ability to contract, allowing more oxygen-rich blood to be pushed out through the body.
Incorporating a rechargeable battery with 20-year battery life, the Optimizer Smart Mini offers heart failure (HF) diagnostic monitoring that provides important clinical insights for providers to assist in managing their patients with heart failure.
This latest generation also offers internal technology with improved programming and a smaller size designed to make the implant procedure faster and easier for patients and physicians.
Source: BERNAMA News Agency
