New FDA Approved Devices for Cardiac Ablation Without Fluoroscopy to Treat AF

Biosense Webster Inc. (part of Johnson & Johnson MedTech), announced that 6 medical products were recently approved by the U.S. Food and Drug Administration for catheter ablation without fluoroscopy to treat atrial fibrillation.

The products that are approved to be used in a zero fluoroscopy workflow include the 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.

Fluoroscopy is a type of medical imaging that displays a continuous x-ray image on a monitor and is used in many examinations and procedures, including cardiac ablation to treat patients with atrial fibrillation. This procedure commonly requires fluoroscopy to guide the insertion and positioning of intracardiac catheters. However, fluoroscopy can result in high radiation exposure, especially for complex procedures that require fluoroscopy to be given for a long period of time. The patient, operator, and medical support staff suffer from an increased long-term risk for cancer from the radiation and musculoskeletal pain from wearing heavy personal protective equipment during the procedure. Biosense Webster’s integrated medical device ecosystem anchored by the CARTO^® 3 mapping and navigation system, enables these newly FDA-approved diagnostic and treatment catheters to conduct cardiac ablation procedures without fluoroscopy, which improves safety and efficiency of the procedure. 

The approval of these medical devices is supported by data collected from the REAL AF Registry (an observational, prospective, and multicenter registry) that assesses real-world catheter ablation clinical outcomes—procedural efficiency, safety, and long-term effectiveness—in patients with paraoxysmal atrial fibrillation who have received ablation with radiofrequency technologies, which do not use fluoroscopy.  

Jose Osorio, MD, FHRS and President of Heart Rhythm Clinical and Research Solutions said in a press release,¹ “Eliminating or reducing radiation exposure is beneficial to patients as well as physicians and staff working every day in the electrophysiology lab.” Overall, catheter ablation without fluoroscopy is a safe, effective, and reduces radiation exposure for all persons involved in the procedure.