FDA approves Boston Scientific navigation-enabled IntellaNav catheters


Boston Scientific has received US Food and Drug Administration (FDA) approval for two catheters that can be used with the company’s Rhythmia mapping system.

The IntellaNav XP and the IntellaNav MiFi XP navigation-enabled ablation catheters–designed to map and ablate–have been approved to treat type I atrial flutter. These are the first magnetically-tracked catheters that Boston Scientific will offer to the US market. Along with the immediate launch of the catheters, the company is also releasing a software enhancement for the Rhythmia mapping system.

“By combining these new magnetic navigation-enabled catheters with our high-density, high-resolution Rhythmia Mapping System, we can create enhanced maps that help diagnose arrhythmias and improve guidance during cardiac ablation procedures,” says Kenneth Stein, chief medical officer of Rhythm Management at Boston Scientific.

Unlike conventional cardiac mapping systems, the Rhythmia mapping system is designed to rapidly and automatically generate three-dimensional images of any chamber of the heart to help diagnose, locate and treat the source of rhythm abnormality. The Software Version 1.4 mapping system update should improve 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 is also intended to provide 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. The IntellaNav MiFi XP catheter is also intended to provide increased accuracy and signal clarity via mini-electrode technology, which should deliver a highly localised signal closely reflecting what is happening at the tip in real-time during the ablation procedure.