Products that received approval include the ThermoCool SmartTouch SF catheter, the most commonly used ablation catheter for radiofrequency ablation. The portfolio’s approved products also include the standard ThermoCool SmartTouch and Carto Vizigo bi-directional guiding sheath. Biosense Webster’s Pentaray Nav Eco high-density mapping catheter, DecaNav mapping catheters and the Webster CS catheter also picked up approval.
Updated workflows indicate that direct imaging guidance, like ultrasound, can offer an alternative to fluoroscopy.
“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.”
Dr. Jose Osorio noted that cardiac ablation procedures that treat AFib can result in considerable radiation exposure. This, along with high orthopedic burden from protective equipment, impacts patients, operators and support staff.
“Eliminating or reducing radiation exposure is beneficial to patients as well as physicians and staff working every day in the electrophysiology lab,” Osorio said. Osorio serves as president of Heart Rhythm Clinical and Research Solutions.
How Biosense Webster picked up FDA approval
Biosense Webster said the label change came on the back of an observational, prospective, multicenter registry.
The registry assesses real-world catheter ablation clinical outcomes for paroxysmal AFib patients. That includes procedural efficiency, safety and long-term effectiveness for novel radiofrequency technologies.
Biosense Webster says its REAL AF registry is a first-of-its-kind real-world evidence registry in the electrophysiology field.
Anthony Hong, VP, preclinical & clinical research and medical affairs, Cardiovascular & Specialty Solutions, Johnson & Johnson, said the novel approach to evidence generation, utilizing real-world evidence, helped secure regulatory approval. Hong added that the approach could lower study costs and achieve faster regulatory milestones in the future.
