Noninvasive ECG mapping system for arrhythmia ‘hot spots’ gains FDA clearance
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Vektor Medical announced the FDA has given 510(k) clearance for its novel ECG mapping system, designed to map “hot spots” associated with stable or unstable arrhythmias anywhere in the heart.
According to a company press release, in less than 3 minutes, the noninvasive ECG mapping system (vMap) can identify arrhythmia sources in all four chambers, the septal wall and the outflow tracts, which can lead to improved outcomes in ablation procedures.
When using the ECG mapping system, a clinician would input case information, download and markup an ECG in the system and receive a 3D interactive map visualizing the inside and outside of the heart and any arrhythmia hot spots, according to the release.
Following clearance, the system will be commercially available across the U.S.
“Traditional arrhythmia mapping techniques are labor-and time-intensive, and physicians are only able to achieve complete success in a limited number of ablation procedures due to the lack of information on arrhythmia source locations. To shorten procedure times and improve ablation success, electrophysiologists need to be able to visualize arrhythmia hot spots in the heart quickly and accurately,” Amir Schricker, MD, MS, medical director of cardiac electrophysiology at Mills Peninsula Medical Center in Burlingame, California, said in the release. “Our clinical experience with vMap has been incredibly positive. Using noninvasive ECG data, the system is extremely simple and fast to use, and quickly provides a hot spot map so we know where to target our efforts without having to navigate the whole heart or order additional imaging.”
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