USA —Biosense Webster, a distinguished entity within Johnson & Johnson MedTech has unveiled its triumphant achievement of gaining U.S. Food and Drug Administration (FDA) approval for a zero-fluoroscopy workflow for a range of its cardiac ablation products.
This transformative breakthrough signals a paradigm shift, permitting the utilization of alternative imaging modalities like ultrasound for direct guidance, resonating with the promise of enhanced procedural efficiency, safety, and enduring efficacy.
Biosense Webster’s pioneering feat ushers in a new era for cardiac ablation, propelled by the official approval granted to a spectrum of its innovative products.
This remarkable endorsement extends to a suite of essential tools, including the globally renowned THERMOCOOL SMARTTOUCH SF catheter—a preeminent radiofrequency (RF) ablation catheter used extensively worldwide.
The distinguished lineup also embraces the THERMOCOOL SMARTTOUCH Catheter, the CARTO VIZIGO Bi-Directional Guiding Sheath, the PENTARAY NAV ECO High-Density Mapping Catheter, the DECANAV Mapping Catheters, and the Webster CS Catheter.
Significantly, this transformational shift signifies a departure from conventional fluoroscopy, extending the scope to incorporate advanced direct imaging techniques such as ultrasound.
The driving force behind Biosense Webster’s remarkable achievement is the REAL AF Registry—an unparalleled endeavor within the realm of electrophysiology.
Conceived in 2019 and cultivated through the collaborative efforts of dedicated physicians, this real-world evidence registry casts a comprehensive spotlight on catheter ablation clinical outcomes.
Rooted in an observational, prospective, multicenter approach, this registry delves into the intricate tapestry of real-world experiences, evaluating procedural efficiency, safety, and the enduring effectiveness of novel radiofrequency (RF) technologies within diverse patient populations grappling with paroxysmal atrial fibrillation (AFib).
Addressing a looming epidemic
The reverberations of Biosense Webster’s groundbreaking achievement resonate against the backdrop of a mounting healthcare challenge: cardiac arrhythmias.
A distressing phenomenon on the rise, atrial fibrillation (AFib) stands as the most prevalent form of cardiac arrhythmia, impacting an astounding 37.5 million individuals across the globe, with a staggering 6 million of them residing in the United States.
The progressive nature of AFib poses an ominous specter, carrying the potential to deteriorate over time or pave the way for dire complications, including heart disease and stroke.
At the heart of this medical revolution lies catheter ablation—a transformative procedure that endeavors to recalibrate the heart’s erratic electrical signals, curbing the onslaught of abnormal heart rhythms.
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