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FDA clears Medtronic’s cardiac electrical mapping system

Published 03 February 2017

Medtronic has secured the 510(k) clearance from the US Food and Drug Administration (FDA) for its cardiac electrical mapping system.

The CardioInsight Noninvasive 3D Mapping System is capable of mapping a range of irregular heart rhythms in the upper and lower chambers of the heart besides generating electroanatomic 3D maps of the heart.

While Cardiac mapping is generally done by introducing a catheter into the heart through either an artery or vein to help physicians detect the origin of irregular heart rhythms (arrhythmias) in the patient, CardioInsight system on the other hand is noninvasive.

Medtronic AF Solutions business vice president and general manager Colleen Fowler said: "The CardioInsight system further expands the portfolio of solutions available for common and complex arrhythmias.

"This technology - which has been in development for decades - is now poised to drive greater physician insights and new advancements in the study and treatment of infrequent, unstable cardiac rhythms in a noninvasive, patient-friendly manner."

Medtronic’s cardiac electrical mapping system has a 252-electrode sensor vest worn by the patient to connect surface electrical data of the body with heart-torso anatomy.

CardioInsight system’s noninvasive technology generates 3D electroanatomic maps of the heart by gathering electrocardiogram (ECG) signals from the chest, and merging these signals with data obtained via a computed tomography (CT) scan of the heart.

Medtronic purchased CardioInsight in 2015 which is now a part of the former’s AF Solutions business in the Cardiac Rhythm and Heart Failure unit.

The Irish medical technology company is planning to implement a strategic release of the CardioInsight technology in regions where it is cleared.


Image: Medtronic's operational headquarters in Minneapolis. Photo: courtesy of Medtronic, Inc.