> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Biosense Webster New Label on Cardiac Ablators
- URL: https://www.fdaweb.com/biosense-webster-new-label-on-cardiac-ablators/
- Published: 2023-08-04T12:00:00.000Z
- Updated: 2026-09-14T18:48:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155033

FDA has approved new labeling for several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy workflow to perform procedures. “The updated workflow indicates that direct imaging guidance, such as ultrasound, may be used as an alternative to fluoroscopy,” the company says, adding that reducing fluoroscopy lowers radiation exposure, which may minimize long-term cancer risk. The products approved for the new workflow include: ThermoCool SmartTouch SF catheter, ThermoCool SmartTouch Catheter, Carto Vizigo Bi-Directional Guiding Sheath, Pentaray NAV ECO High Density Mapping Catheter, Decanav Mapping Catheters, and Webster CS Catheter.

The company says it obtained the label change based on an “observational, prospective, multicenter registry that assesses real-world catheter ablation clinical outcomes, including procedural efficiency, safety, and long-term effectiveness in a broad group of patient populations with novel radiofrequency (RF) technologies in paroxysmal AFib patients.”