Technology | October 15, 2009

Biosense Webster Receives FDA Clearance for CARTO 3 EP Navigation System

The CARTO3 EP navigation system.

October 15, 2009 – Biosense Webster Inc. said today the U.S. Food and Drug Administration cleared the CARTO 3 System, an advanced 3D imaging technology for use by electrophysiologists in treating cardiac arrhythmias.

The CARTO 3 System offers three unique features: advanced catheter location (ACL) technology, fast anatomical mapping (FAM), and a streamlined workflow feature set referred to as Connection of Choice. The company said these features work in tandem to enhance a physician’s ability to treat an array of simple and complex cardiac arrhythmias.

ACL is a hybrid technology that allows for accurate catheter tip and curve visualization without spatial distortion. This helps the electrophysiologist to orient catheters with precision for diagnostic and therapeutic applications. The system can visualize up to five catheters simultaneously with clear distinction of all electrodes.

FAM is a leading-edge technology that quickly and accurately creates high-resolution, CT-like maps as quickly as an EP can move his or her catheter throughout the cardiac chamber. FAM technology also permits detailed visual enhancement of a specific area of interest within the heart.

Connection of Choice is enabled by the 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 redesigned 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.

“The CARTO 3 System is an exciting technology that represents a major step forward for electrophysiologists,” said Vivek Y. Reddy, M.D., director, cardiac arrhythmia service, The Zeng and Michael A. Wiener Cardiovascular Institute, The Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, and professor of medicine, Mount Sinai School of Medicine in New York. He is also one of the leaders of the recent external evaluations for the new CARTO 3 system. “I was especially impressed with the fast anatomical mapping feature. I was able to create a map quickly and the accuracy was excellent. In addition, I was pleased with how the system merged with our CT scan. Overall, the evaluation was a great experience for the whole lab team who enjoyed the new quick system set up.”

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