CardioInsight 3D cardiac mapping system receives approval by the FDA
Orange County, CA - February 10th 2017 - An electrophysiology study, or cardiac mapping, is used to find the cause of problematic heart rhythms, like arrhythmia. Performed by an electrophysiologist, a trained expert in the heart’s electrical systems, the doctor makes a small incision in the neck or thigh before inserting a catheter to the heart via an artery or vein. Electrodes attached to the end of the catheters then gather data form the signals surging through the heart thus pinpointing problem areas.
This procedure is invasive which can potentially lead to internal injury, infection, and other negative outcomes. To combat these risks, Medtronic has released their noninvasive CardioInsight 3D cardiac mapping system. Just cleared by the FDA, the system is comprised of an ECG vest that sends signals to a computed tomography (CT) scanner. The vest, which contains 252 electrodes, collects electric signals from the skin’s surface while undergoing a CT scan. That information is then superimposed with data from the CT scan to create a 3D image of the heart and its electrical activity.
"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 provider’s right at their bedside," said Dr. Vivek Reddy, director of cardiac arrhythmia services at the Mount Sinai Hospital and the first to use the system commercially. "This system shifts mapping away from the EP lab, potentially saving time and enhancing the patient experience."
The vest is a single use, disposable item and comes in 4 sizes. Hugging the silhouette of the wearer, the device continuously creates a panoramic map of either both atria or both ventricles simultaneously. Current invasive methods are incapable of such provisions. The vest also serves physicians with a more complete view of the heart, for the length of time it is worn allows it to catch transient arrhythmias that could go undetected during an ECG test.
A single captured heartbeat is able to be turned into an interactive 3D color cardiac map with the CardioInsight software, allowing rapid mapping of the heart’s rhythms alongside numerous cardiac signal analyses. The system’s precursor has been used on more than 1,600 patients in Europe and the United States, with it being displayed in over 120 peer-reviewed journals and presentations.
Medtronic acquired CardioInsight in 2015, and will begin to rollout the new technology as it is cleared by international standards and compliances.
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CardioInsight 3D cardiac mapping system receives approval by the FDA Orange County, CA – February 10th 2017 – An electrophysiology study, or cardiac mapping, is used to find the cause of problematic heart rhythms, like arrhythmia. Performed by an electrophysiologist, a trained expert in the heart’s electrical systems, the doctor makes a small incision in the neck […]