Biosense Webster Granted FDA Approval for Multiple Atrial Fibrillation Ablation Products Designed for Fluoroscopy-Free Workflow
Saturday, August 05, 2023
Biosense Webster, a leading global company in cardiac arrhythmia treatment and a part of Johnson & Johnson MedTech, has announced that multiple products in its cardiac ablation portfolio have received approval from the U.S. Food and Drug Administration (FDA) for a zero fluoroscopy workflow. The approved products include the THERMOCOOL SMARTTOUCH™ SF catheter, which is widely used for RF ablation, as well as the THERMOCOOL SMARTTOUCH™ Catheter, CARTO® VIZIGO® Bi-Directional Guiding Sheath, PENTARAY® NAV ECO High-Density Mapping Catheter, DECANAV® Mapping Catheters, and Webster® CS Catheter.
The new workflow allows for direct imaging guidance, such as ultrasound, to be used as an alternative to fluoroscopy, which is a medical imaging technique involving continuous X-ray imaging on a monitor. This change is significant as fluoroscopy can expose patients to high radiation doses during complex interventional procedures, leading to potential long-term cancer risks and musculoskeletal pain from wearing heavy protective equipment like lead aprons.
The FDA-approved label change highlights the Biosense Webster integrated ecosystem's capabilities, anchored by the CARTO® 3 mapping and navigation system, and their diagnostic and treatment catheters, in enabling a workflow without the need for fluoroscopy. This advancement enhances the safety and efficiency of cardiac ablation procedures, benefitting both medical professionals and patients alike.