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Biosense Webster Receives FDA Clearance for the CARTO® 3 System – Catheter Mapping and Placement

Posted Oct 15 2009 10:01pm

Navigation for catheter placement is going high tech as well.  With the rise of interventional technologies, this allows the interventional cardiologist image or radiologist to ensure exact placement through better visual processes.

The system also integrates with other technologies, something we hear a lot about with Health IT, and this is further evidence of technology leading the way with integrating imaging from other software, such as a DICOM image to be imported into the software.

Who would have ever thought the words “plug and play” and “point and click” would be utilized with healthcare a few years ago, but it goes to show the importance of computer technology and how it creates accuracy and saves lives by reducing error.  Given a choice of an X-Ray or 3D modeling there’s not much to say as far as which could offer the best visual mapping capabilities with catheters.  BD 


“Leading-edge technology creates a map as fast you can move the catheter allowing the rapid creation of high-resolution, CT-like maps with proven CARTO System accuracy”

State-of-the-Art Navigational Mapping System Offers Unique Combination of Accuracy, Speed and Efficiency DIAMOND BAR, Calif.-- image (Business Wire)-- Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced today that the U.S. Food and Drug Administration (FDA) has cleared for marketing the CARTO® 3 System, the most advanced three-dimensional imaging technology for use by electrophysiologists in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms. It is estimated that 20 million people in the United States suffer from some sort of arrhythmia. Atrial Fibrillation, or AFib as it`s more commonly known, is the most prevalent cardiac arrhythmia affecting between 2.3 to 5.6 million adults in the United States alone and is the leading cause of stroke among people 65 years and older.

Earlier this year, the FDA approved the NAVISTAR® THERMOCOOL® Catheter,including its bidirectional EZ STEER® Catheter platform, as safe and effectivefor the treatment of drug refractory recurrent symptomatic paroxysmal atrialfibrillation when used with the CARTO® System. The NAVISTAR® THERMOCOOL®Catheters are the first and the only ablation catheters approved by the FDA forthe treatment of AFib.

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CONNECTION OF CHOICE™ is enabled by the brand new CARTO® System hardware configuration featuring a central connection point for all catheters and equipment while preserving the signal quality of intracardiac electrograms. Catheter connections have been re-designed for "plug-and-play" functionality and automatic catheter recognition. All of these enhancements have been developed to streamline and simplify workflow in the EP lab.

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Biosense Webster Receives FDA Clearance for the CARTO® 3 System | Reuters

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