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U.S. FDA Approve Boston Scientific “Navigation-Enabled Ablation Catheters”

Boston Scientific get U.S. Food and Drug Administration (FDA) approval for two catheters that can be used with the Rhythmia™ Mapping System. The IntellaNav™ XP and the IntellaNav MiFi™ XP navigation-enabled ablation catheters were approved to treat Type I atrial flutter. These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market. Type I atrial flutter  is an abnormal rhythm of the upper chambers of the heart.

Rhythmia Mapping System rapidly and automatically generates three-dimensional images of any chamber of the heart to help diagnose, locate and treat the source of rhythm abnormality as compared to conventional cardiac mapping systems.  The Software Version 1.4 mapping system update improves the speed and quality.

The software will also provides advanced editing capabilities, allowing for detailed visual enhancements of the maps. Both of the newly approved IntellaNav XP catheters feature magnetic sensors which track the location of the catheter while delivering radiofrequency energy into the heart muscle, creating heat to destroy a small area of the tissue responsible for the abnormal heart rhythm.

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