FDA Clears CardioInsight 3D Mapping System for Arrhythmias

Patrice Wendling

February 01, 2017

The US Food and Drug Administration today granted 510(k) clearance for the first noninvasive 3D cardiac electrical mapping system in the world, according to the device manufacturer[1].

The CardioInsight 3D Mapping system (Medtronic) uses a 252-electode sensor vest worn by the patient to create 3D electroanatomic maps of the heart by combining ECG signals collected from the chest with data from a cardiac computed tomography scan. The vest technology allows for continuous and simultaneous mapping of the atria or ventricles and can create the 3D maps by capturing a single heartbeat, the company explained in a news release.

Cardiac mapping is traditionally achieved by inserting a catheter into the heart via an artery or vein.

In the news release, Dr Vivek Reddy (Mount Sinai Hospital, New York, NY) said, "By offering this noninvasive approach, we are effectively streamlining the clinical procedure planning process for clinicians and making it easy for patients to receive precise mapping results from their providers right at their bedside." Reddy was the first to use the system commercially in the US and consults for and receives research funding from Medtronic.

Medtronic acquired CardioInsight in 2015.

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