FDA clears heart mapping system that hunts down arrhythmias using only a 12-lead ECG

To treat a persistent arrhythmia, surgeons need to know more than just that the heart’s beats are out of sync—they need a map of the cardiac muscle’s electrical activity to see exactly where things are going wrong. 

That typically means scheduling CT, MRI or ultrasound scans; performing intricate, catheter-based procedures to probe the inside of the heart or having the patient don specially designed vests woven with dozens of electrodes.

But now, the FDA has cleared a novel system from Vektor Medical that builds a model of the heart’s electrophysiology using data gleaned from a 12-lead electrocardiogram. By coupling standard ECG hardware with the company’s software, clinicians can chart out arrhythmia hotspots noninvasively in 2D and 3D diagrams and in less than three minutes.

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The vMap system is designed to locate the potential sources of irregular beats across the heart’s four main chambers as well as in its outflow tracts and internal walls. According to the company, the program has shown success in tracking down a variety of different arrhythmias including atrial fibrillation and that it can be used alone or alongside traditional diagnostic systems.

Earlier this year, Vektor demonstrated how vMap could assist in planning stereotactic ablative radiotherapy procedures for treating ventricular tachycardia. A prospective study showed the system could precisely localize VT sources in all of its seven cases. The results were published in the Heart Rhythm Society’s journal Heart Rhythm O2.

“Cardiac arrhythmias impact millions of people across the globe, increasing the risk of serious health-related issues such as stroke, heart failure and even death,” Vektor Medical CEO Mike Monko said in a statement. “Yet, today’s therapies have significant issues—drug therapy can have severe side effects, and nontargeted ablation has disappointingly low success rates.” 

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Meanwhile this past summer, the FDA cleared a heart-mapping platform from CardioNXT, which pairs patches worn on the chest with an internal reference catheter outfitted with electromagnetic sensors. That system provides 3D guidance for cardiac ablation treatments similar to surgical systems designed for brain, spine and lung procedures.

And in early 2020, Acutus Medical received an agency green light for its real-time, noncontact catheter mapping platform, which allows surgeons to scan the inside of the heart’s chambers, perform an ablation and then quickly remap the organ to confirm the effects of the procedure.