Noninvasive Cardiac Mapping Vest Receives FDA Clearance

(CardioInsight™ Mapping Vest. Image courtesy of Medtronic.)

First used commercially in the United States this week, a noninvasive mapping system by Medtronic has just received 510 (k) clearance from the US Food and Dug Administration (FDA).

The device, officially known as the CardioInsight Noninvasive 3D Mapping System, takes the form of an external vest that contains 252 electrode sensors that collect electrocardiogram signals in order to create 3D electroanatomic maps of the heart. As per a press release, by contouring to the torso the device “allows for continuous and simultaneous panoramic mapping of both atria or both ventricles, which cannot be achieved with current invasive methods.”

The rapidity of the mapping technology is noteworthy, claiming the ability to create a map after capturing a lone heartbeat. Cardiac mapping is an important diagnostic tool in understanding arrhythmias and their risks.

Vivek Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital, believes the technology represents both greater convenience in diagnosis and a potential cost-savings: “This system shifts mapping away from the EP lab, potentially saving time and enhancing the patient experience." Reddy, it should be noted, also receives financial consideration as a consultant for Medtronic.

CardioInsight was acquired by the company in 2015 and rolled into the Cardiac Rhythm and Heart Failure division of Medtronic AF Solutions.

The announcement of the FDA’s approval was made today in a press release from the company, which says it “will employ a strategic rollout of the technology in the geographies where it is cleared.”

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