Biosense Webster, a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson, has announced that several products in its cardiac ablation portfolio have received approval for a zero fluoroscopy workflow from the U.S. Food and Drug Administration (FDA). The workflow update allows for the use of direct imaging guidance, such as ultrasound, as an alternative to fluoroscopy, which can reduce radiation exposure and minimize long-term cancer risk. The label change was based on a real-world evidence registry that assessed the clinical outcomes of catheter ablation procedures. Cardiac arrhythmias, including atrial fibrillation, are a growing epidemic and impact millions of people worldwide. The approval of the zero fluoroscopy workflow will improve the safety and efficiency of cardiac ablation procedures.
Fri, 04 Aug 2023 13:03:18 GMT | Johnson & Johnson