Vektor Medical announced that it has received 510 (k) clearance from the FDA for its new vMap ECG mapping system to identify potential sources of arrhythmia.
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. This includes all four chambers, the septal wall and the exit tracts, in less than three minutes using only ECG data, according to a press release.
The company said the vMap, which will become commercially available to sites across the United States after receiving clearance, improves the results of ablation procedures.
vMap takes less than three minutes for a clinician to enter case information, upload and annotate an ECG into the system, and receive a three-dimensional interactive arrhythmia hotspot map visualizing both inside and outside of the system. heart. Vektor said it can be used as a non-invasive stand-alone tool or as a complement to traditional invasive electroanatomic mapping systems in planning and procedural settings.
“With vMap, we are changing the way electrophysiologists think about mapping,” Vektor Medical CEO Mike Monko said in the statement. âBy providing a hot spot map in just minutes based on non-invasive ECG data, physicians can create a more efficient ablation plan and spend less time searching for target locations.
âOur goal is to increase first pass success rates, reduce risk and lower the current cost of ablation to the healthcare system. “