Medtronic, CardioInsight

Medtronic Wins FDA Clearance for First Noninvasive Cardiac Electrical Mapping System

By MedTech Intelligence Staff
Medtronic, CardioInsight

The technology helps doctors find the origin of an irregular heart rhythm.

When a patient has an arrhythmia, doctors usually find it via cardiac mapping. This method involves the insertion of a catheter into the heart through an artery or vein. Medtronic is providing the first commercial noninvasive solution for this approach with the CardioInsight Noninvasive 3D Mapping System. The technology received 510(k) approval from FDA and can be used to map arrhythmias in the upper and lower heart chambers.

The CardioInsight system creates 3-D electroanatomic maps of the heart by collecting electrocardiogram signals from the chest (the patient wears a 252-electrode sensor vest) and combines these with data from a CT scan of the heart (view the animation). A differentiating factor from invasive methods is that the technology provides continuous and simultaneous panoramic mapping of the atria and ventricles, because the vest contours to the patient’s body.

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