Biosense Webster Receives FDA Approval for Zero-Fluoroscopy Workflow for Multiple AFib Ablation Products

August 4, 2023—Biosense Webster, Inc., part of Johnson & Johnson MedTech, announced FDA approval for a zero-fluoroscopy workflow approach that applies to several currently available products in its cardiac ablation portfolio for treating atrial fibrillation (AFib).

The products that can be used in this workflow include Biosense Webster’s ThermoCool SmartTouch SF radiofrequency (RF) ablation catheter, ThermoCool SmartTouch catheter, Carto Vizigo bidirectional guiding sheath, Pentaray Nav Eco high density mapping catheter, DecaNav mapping catheters, and the Webster CS catheter.

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

According to Biosense Webster, the company received the label change based on the observational, prospective, multicenter REAL AF registry, which assesses real-world catheter ablation clinical outcomes, including procedural efficiency, safety, and long-term effectiveness in a broad group of patient populations with novel RF technologies in paroxysmal AFib patients. The REAL AF Registry is led by physicians and has been supported by Biosense Webster since 2019.

“Cardiac ablation procedures for the treatment of AFib usually require fluoroscopy to guide the advancement and positioning of intracardiac catheters, resulting in considerable radiation exposure for patients, operators, and support medical staff as well as a high orthopedic burden from protective equipment such as lead aprons,” commented Jose Osorio, MD, in the Biosense Webster press release. Dr. Osorio, who is President of Heart Rhythm Clinical and Research Solutions, a contract research organization, continued, “Eliminating or reducing radiation exposure is beneficial to patients as well as physicians and staff working every day in the electrophysiology lab.”

Jasmine Brooks, President, Biosense Webster, advised in the press release, “The label change approved by the FDA underscores that the Biosense Webster integrated ecosystem, anchored by the Carto 3 mapping and navigation system, together with our diagnostic and treatment catheters, enables workflows with zero fluoroscopy, which improves safety, and efficiency of cardiac ablation procedures. As a result of this update, our teams can now proactively discuss the fluoroscopy alternative workflow with our customers to reinforce the benefits of the Biosense Webster portfolio of products.”