3D-Mapping Gets 501K FDA Clearance

The CARTO mapping system from Biosense Webster, a Johnson and Johnson company, got FDA clearance for marketing today. It uses three different magnetic fields to localize a magnetic catheter in three-dimensional space within the heart and references cardiac activity from the catheter to a specific location in the heart. The ONLY problem with this system is that is has to use their magnetic catheter and can collect data from one location at a time. If the patient moves, recreating the three-dimensional anatomy again takes time. It has some impressive software features that help our understanding of complex arrhythmias, and the new "CARTO Merge" is fascinating software that can take a 3-D picture dataset created from a high-resolution CT scan image of the heart, and superimpose a 3D rendering of the inside of the heart with electrical data over that previously-acquired CT scan image.

The competing system from Endocardial Solutions and distributed by St. Jude, called NavX, uses three separate electric fields in an x,y,z coordinate system to localize a conventional EP catheter in 3-D space, and also faciltiates our understanding of the mechanism of heart rhythm abnormalities in complicated ablation procedures. It too has "merge-like" software on the horizon, but presently displays the 3D reconstruction image and 3D CT-acquired image side by side.

Look for routine use of this technology in EP labs as atrial fibrillation ablation procedures increase in frequency.

--Wes