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# Boston Scientific Ablation Catheters Approved for Mapping Use
- URL: https://www.fdaweb.com/boston-scientific-ablation-catheters-approved-for-mapping-use/
- Published: 2016-05-04T12:00:00.000Z
- Updated: 2026-09-14T20:59:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135580

FDA has approved a Boston Scientific PMA for two catheters that can be used with its Rhythmia Mapping System — the IntellaNav XP and the IntellaNav MiFi XP navigation-enabled ablation catheters — which are intended to treat Type I atrial flutter. “These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market,” the company says, adding that a software enhancement for its mapping system was also approved.

“Unlike conventional cardiac mapping systems, the 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,” Boston Scientific says. “The Software Version 1.4 mapping system update improves the speed and quality in which the images are acquired using a variety of therapeutic and diagnostic catheters, including the IntellaNav XP and IntellaNav MiFi XP catheters. The software update also provides advanced editing capabilities, allowing for detailed visual enhancements of the maps.”

Both 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, the company says. “The IntellaNav MiFi XP catheter also provides increased accuracy and signal clarity via mini-electrode technology which delivers a highly localized signal closely reflecting what is happening at the tip in real-time during the ablation procedure,” it adds.