Biosense Webster Launches Carto 3 System Confidense Module for High-Density Mapping During Catheter Ablation Procedures

June 18, 2015—Biosense Webster, Inc. announced the launch of the Confidense module, which is designed to streamline the creation of real-time three-dimensional (3D) maps of a patient’s cardiac structures during catheter ablation procedures. The Confidense module has received European CE Mark approval and US Food and Drug Administration 510(k) clearance in the United States, where it will be widely available in July.

The Confidense module uses an algorithm that enhances the process for validating information, or “points,” acquired during multielectrode mapping, enabling electrophysiologists to focus on the most relevant data during mapping. 

According to Biosense Webster, multielectrode mapping allows for the rapid acquisition of a large quantity of data used to generate detailed, high-density maps on the company’s Carto 3 imaging system, which uses electromagnetic technology to create real-time 3D maps of a patient’s cardiac structures. The Carto 3 system generates an accurate 3D map to navigate the heart, as well as to pinpoint the exact location and orientation of catheters in the heart during catheter ablation procedures for patients with cardiac arrhythmias.

The Confidense module offers new features that simplify and accelerate map creation while maintaining accuracy. The module also provides a real-time assessment of whether catheter electrodes are in proximity to heart tissue while selectively using the points closest to the tissue to generate a high-quality 3D map, enhances the consistency of quality data acquisition with an advanced algorithm, and accurately identifies and quickly evaluates points whose timing is judged to be inconsistent in comparison with neighboring points, which are then flagged and immediately brought to the physician’s attention, stated the company.

In the company’s press release, Vias Markides, MD, commented, “While high-density maps generated through multielectrode mapping provide the most comprehensive and accurate image of the cardiac structures, this process can prove to be time intensive. The new Confidense module streamlines the mapping and validation process, which has the potential to reduce overall mapping, annotation, and reannotation time. I’m pleased that continued innovation in this space is enabling us to realize important clinical efficiencies while preserving the critical data and accuracy we have come to rely on from the Carto system.” Dr. Markides is Director of the Heart Division at Royal Brompton Hospital in London, United Kingdom.