Medtronic gets FDA clearance for cardiac-mapping vest

By Heather Mack
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Figuring out what is causing an irregular heartbeat typically means an invasive procedure: most often, electrophysiologists insert a catheter to the heart via an artery or vein to get a cardiac “map” and identify the origin of the arrhythmia. But a new device from Medtronic takes the process outside, in the form of a sensor-enabled vest.

Dubbed the CardioInsight Noninvasive 3D Mapping System, the single-use, disposable wearable received FDA 510(k) clearance last week, following a predecessor system that was used in more than 1,600 patients. In addition to having the benefit of being non-invasive, the vest may also give physicians more insights, as it can be worn long enough to catch transient arrhythmias that could otherwise be missed on a one-time ECG test.

The vest features 252 electrode sensors to provide a wide range of electroanatomic 3D maps of the upper and lower chambers of the heart, and works by pairing body surface electrocardiogram (ECG) signals from the chest, then combining them with data from a computed tomography (CT) scan of the heart and connecting to the CardioInsight Workstation. It comes in four sizes, contouring to the wearer’s body and enabling continuous, simultaneous panoramic mapping of both atria or both ventricles (which can’t be done with the catheter method).

“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 AF Solutions Vice President and General Manager Colleen Fowler said in a statement.

Dr. Vivek Reddy, director of cardiac arrhythmia services at Mount Sinai Hospital and consultant to Medtronic, was the first to use the device commercially.

 “This system shifts mapping away from the EP lab, potentially saving time and enhancing the patient experience,” Reddy said in a statement. “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.”

Medtronic, which acquired CardioInsight in 2015, will now begin rolling out the vest where the device is cleared.