Boston Scientifics’ ablation catheters secure US FDA approval

3 May 2016 (Last Updated May 3rd, 2016 18:30)

The US Food and Drug Administration (FDA) has granted approval to Boston Scientifics' two catheters which can be used with the rhythmia mapping system (RMS).

Catheter

The US Food and Drug Administration (FDA) has granted approval to Boston Scientifics' two catheters which can be used with the rhythmia mapping system (RMS).

The two navigation-enabled ablation catheters, IntellaNav XP and the IntellaNav MiFi XP, are intended to map and ablate to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart.

Following the approval, Boston Scientific will introduce the first magnetically-tracked catheters in the US market.

The company will also release a software enhancement for the Rhythmia Mapping System.

Boston Scientific rhythm management chief medical officer Kenneth Stein said: "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."

"By combining navigation-enabled catheters with our high-density, high-resolution rhythmia mapping system, we can create enhanced maps that help diagnose arrhythmias."

The RMS allows a quick and automatic generation of 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 enhances the speed of acquiring the images and its quality using a range 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.

The IntellaNav XP catheters is incorporated with magnetic sensors which detects 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 promotes increased accuracy and signal clarity via mini-electrode technology which delivers localised signal closely replicating the happening at the tip in real-time during the ablation procedure.


Image: A view of cardiac catheterisation laboratory. Photo: courtesy of Vuk.