Biosense Webster, Inc., announces that several products in cardiac ablation portfolio have received approval for a zero-fluoroscopy workflow from the U.S. FDA. The products that can be used in this workflow include: 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. The updated workflow indicates that direct imaging guidance, such as ultrasound, may be used as an alternative to fluoroscopy.

Fluoroscopy can result in relatively high radiation doses, especially for complex interventional procedures which require fluoroscopy be administered for a long period of time. Reducing fluoroscopy lowers radiation exposure, which may minimize long-term cancer risk, and can reduce the risk of musculoskeletal pain due to extensive wear of heavy personal protective equipment, such as lead aprons.

“Cardiac ablation procedures for the treatment of atrial fibrillation (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,” says Jose Osorio, MD, FHRS, president of Heart Rhythm Clinical and Research Solutions. “Eliminating or reducing radiation exposure is beneficial to patients as well as physicians and staff working every day in the electrophysiology lab.” 

“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,” adds Jasmina Brooks, President, Biosense Webster. “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.”

The company received the label change based on an observational, prospective, multicenter registry that assesses real-world catheter ablation clinical outcomes, including procedural efficiency, safety, and long-term effectiveness in a broad group of patient populations with novel radiofrequency (RF) technologies in paroxysmal AFib patients. The Real AF Registry is a first-of-its kind real-world evidence registry in the electrophysiology field, led by physicians and supported by Biosense Webster since 2019.

“At Biosense Webster, we are committed to advancing innovative technologies that enable safe, effective, and efficient cardiac ablation procedures, as well as expanding the body of evidence supporting how our technologies are used to improve patient lives,” says Anthony Hong, vice president of preclinical and clinical research and medical affairs, cardiovascular and specialty solutions, Johnson & Johnson.

“Our novel approach to evidence generation, utilizing real-world evidence from the Real AF Registry, has helped us secure regulatory approval for our fluoroscopy alternative workflow, and I’m looking forward to utilizing this approach in the future to lower study costs and achieve faster regulatory milestones,” Hong concludes.