Vektor Medical announced that it received FDA 510(k) clearance for its novel vMap ECG mapping system for spotting potential arrhythmia sources.
San Diego-based Vektor designed vMap to find hot spots in the form of arrhythmia sources associated with stable or unstable arrhythmias anywhere in the heart. That includes all four chambers, the septal wall and the outflow tracts, in less than three minutes using only ECG data, according to a news release.
The company said the vMap, which will become commercially available to sites across the U.S. after receiving clearance, improves outcomes in ablation procedures.
vMap takes less than three minutes for a clinician to input case information, download and markup an ECG in the system and receive a three-dimensional, interactive arrhythmia hot spot map visualizing both the inside and outside of the heart. Vektor said it can be used as a non-invasive standalone tool or as a complement to traditional invasive electroanatomical mapping systems in planning and procedural settings.
“With vMap we are changing how electrophysiologists think about mapping,” Vektor Medical CEO Mike Monko said in the release. “By providing a hot spot map in only minutes based on non-invasive ECG data, physicians can create a more effective ablation plan and spend less time finding target locations.
“Our goal is to increase first-pass success rates, lower risk, and decrease the current cost burden of ablation on the healthcare system.“