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System is available in Europe and United States.
Diamond Bar, Calif.-based Biosense Webster Inc., which makes products for the diagnosis and treatment of cardiac arrhythmias, has released the Confidense module, a technology that streamlines the creation of real-time three-dimensional (3-D) maps of a patient’s cardiac structures during catheter ablation procedures. The module uses a proprietary algorithm designed to enhance the process for validating information, or “points,” acquired during multi-electrode mapping, enabling electrophysiologists to focus their time and expertise on the most relevant data during the mapping process. “While high-density maps generated through multi-electrode mapping provide the most comprehensive and accurate image of the cardiac structures, this process can prove to be time intensive,” said Vias Markides, M.D., director of the Heart Division at Royal Brompton Hospital, London, United Kingdom. “The new Confidense module streamlines the mapping and validation process, which has the potential to reduce overall mapping, annotation and re-annotation 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.” Multi-electrode mapping allows for the rapid acquisition of a large quantity of data used to generate detailed, high-density maps on the Carto 3 system. Previously, validating the information acquired through multi-electrode mapping required a very detailed manual process but the new Confidense module enhances the 3-D mapping experience with several new features meant to simplify and accelerate map creation while maintaining accuracy. The module also provides a real-time assessment of whether catheter electrodes are in proximity with heart tissue while selectively utilizing the points closest to the tissue to generate a high-quality 3-D 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. “We are committed to collaborating closely with the clinical community to introduce novel innovations that not only enable access to the most accurate and comprehensive mapping data available, but in making the acquisition of this data fast, simpler and more intuitive for users,” said David Shepherd, U.S. president, Biosense Webster Inc. “We are excited to introduce this latest innovation for our foundational Carto system platform, a fully integrated system that delivers the most comprehensive suite of solutions for physicians worldwide.” The Confidense module has the CE mark for marketing in Europe and received 510(k) U.S. Food and Drug Administration clearance in the United States where it will be widely available in July.
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