Biosense Webster has announced that several products in its cardiac ablation portfolio have received approval for a zero fluoroscopy workflow from the US Food and Drug Administration (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.
“Cardiac ablation procedures for the treatment of atrial fibrillation (AF) 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 orthopaedic burden from protective equipment such as lead aprons,” explained Jose Osorio, 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,” said 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, multicentere 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 AF 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.
