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INTELLANAV STABLEPOINT™

Ablation Catheter

Clinical evidence

Review real-world clinical and pre-clinical publications and explore the data behind the INTELLANAV STABLEPOINT™ Ablation Catheter.

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NEwTON AF
 
 

NEwTON AF Clinical Study

In a global, prospective, single-arm, multicenter study, researchers evaluated the safety and effectiveness of the INTELLANAV STABLEPOINT Ablation Catheter with DIRECTSENSE™ Technology for the treatment of paroxysmal atrial fibrillation.  At 12 months, the freedom from predefined adverse events was 96.0%, with no recorded steam pops or cases of esophageal fistula. Additionally, at 12 months, freedom from documented recurrence of AF was 73.9%.¹ 
AF Recurrence
Chart
 
Access Results for the NEwTON AF Clinical Study
 

Real-World Experience

Lepillier et al, CHARISMA Registry

In a prospective multicenter study, 212 consecutive AF patients were enrolled for de novo pulmonary vein isolation with the STABLEPOINT Ablation Catheter. High-power short-duration (HPSD) ablation with both contact force and local impedance on the STABLEPOINT Ablation Catheter resulted in high first-pass isolation rate of 93.3% with no reported steam pops or major complications.²

Access Results for the Lepillier CHARISMA Registry Results
 

Local Impedance Drop Summary

For those familiar with DIRECTSENSE on INTELLANAV MIFI™ Open-Irrigated Ablation Catheter, it is important to note that there are differences in how the measurement is calculated. MiFi uses a 4-electrode method of calculating impedance, with current driven from the proximal ring to the tip and changes in the field measured between the mini-electrodes and the distal ring. Because INTELLANAV STABLEPOINT doesn’t have mini-electrodes and has a greater distance between the tip and distal ring, the impedance measurement is different; however, both methods are sensitive to the same biophysical changes.

The key takeaway is that the values may be different, but the accuracy is not!  See examples of the DIRECTSENSE Local Impedance Drops in existing STABLEPOINT literature.

 
Download the Local Impedance Drop Summary for the INTELLANAV STABLEPOINT Catheter
 
Download the STABLEPOINT Clinical Compendium
 
Advance your understanding

Advance your understanding

Continue exploring STABLEPOINT technology on EDUCARE, Boston Scientific’s online medical education platform.
 
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