Technology | EP Mapping and Imaging Systems | February 01, 2017

FDA Clears First Noninvasive Electro-Anatomical Mapping System

The CardioInsight system uses a vest of ECG leads to accurately map the heart’s electrical activity without the need for catheter electromapping
 

medtronic cardioinsight electromapping system, electoanatomical mapping, noninvasive ep mapping

A screen shot of the waveforms and the the 3-D electo-mapping models created using the noninvasive CardioInsight system.

medtronic cardioinsight electromapping system, electoanatomical mapping, noninvasive ep mapping

The CardioInsight ECG lead vest worn by the patient and showing the position of the heart under the leads.

February 1, 2017 — Medtronic received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CardioInsight Noninvasive 3D Mapping System. The CardioInsight system is used to map a wide range of irregular heart rhythms in the upper and lower chambers of the heart, and provides electro-anatomic 3-D maps of the heart. The system was first used commercially in the U.S. by Vivek Reddy, M.D., director of cardiac arrhythmia services at the Mount Sinai Hospital and the Mount Sinai Health System, New York.

 
Cardiac mapping is typically accomplished by inserting a mapping catheter into the heart, allowing physicians to locate the origin of a patient’s arrhythmias. In contrast, the CardioInsight system is the first commercially released, noninvasive, cardiac electrical mapping system in the world, eliminating the invasive steps of this clinical procedure.
 
The CardioInsight system uses a 252-electrode sensor vest that is worn by the patient to pair body surface electrical data with heart-torso anatomy. The noninvasive technology creates 3-D electro-anatomic maps of the heart by collecting electrocardiogram (ECG) signals from the chest, and combining these signals with data from a computed tomography (CT) scan of the heart. The vest technology contours to the patient’s body and allows for continuous and simultaneous panoramic mapping of both atria or both ventricles, which cannot be achieved with current invasive methods. The 3-D cardiac maps can be created by capturing a single heartbeat, and enable rapid mapping of these heart rhythms. The predecessor system has been used with more than 1,600 patients and is featured in more than 120 peer-reviewed journals and presentations.

Watch a short video animation of how the CardioInsight system works.
 
"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 said. “This system shifts mapping away from the EP lab, potentially saving time and enhancing the patient experience.” 
 
Medtronic will employ a strategic rollout of the technology in the geographies where it is cleared. Medtronic acquired CardioInsight in 2015, now part of the Medtronic atrial fibrillation (AF) solutions business in the cardiac rhythm and heart failure division.
 
“The CardioInsight system further expands the portfolio of solutions available for common and complex arrhythmias,” said Colleen Fowler, vice president and general manager of the AF Solutions business. “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.”
 
Reddy receives financial compensation as a consultant to Medtronic, as well as research grant support from Medtronic.

Watch video showing examples of how the CardioInsight system works in the VIDEO “Editor's Choice of Innovative Technology at Heart Rhythm Society 2012.”

For more information: www.medtronic.com

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