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Biosense Webster receives FDA approval for a zero fluoroscopy workflow in cardiac ablation

Biosense Webster, a part of Johnson & Johnson MedTech, has announced that several products in its cardiac ablation portfolio have received approval for a zero fluoroscopy workflow from the FDA. The products that can be used in this workflow include:

  • THERMOCOOL SMARTTOUCH™ SF catheter – the most commonly used ablation catheter in the world for RF ablation
  • THERMOCOOL SMARTTOUCH™ Catheter
  • CARTO® VIZIGO® Bi-Directional Guiding Sheath
  • PENTARAY® NAV ECO High Density Mapping Catheter
  • DECANAV® Mapping Catheters
  • Webster® CS Catheter

The updated workflow indicates that direct imaging guidance, such as ultrasound, may be used as an alternative to fluoroscopy.

Read more about the first AFib ablation products to receive FDA approval for use in a workflow without fluoroscopy here.

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