FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation

Johnson & Johnson Medical Devices Companies have announced the U.S. FDA approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the treatment of persistent atrial fibrillation (persistent AF).


Atrial fibrillation (AF) is a significant public health issue affecting the health of millions of people and placing a critical burden on healthcare systems. Persistent AF is defined as continuous AF that lasts for more than seven days and up to one year. The management of persistent AF aims to prevent AF recurrence and associated disabilities while reducing side effects from treatment.

Biosense Webster, Inc. describes itself as the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. The company’s CARTO® 3 System and THERMOCOOL SMARTTOUCH® SF Catheter allow for a patient-tailored approach to ablation, resulting in high long-term effectiveness in persistent atrial fibrillation patients.

The FDA approval is based on results of a prospective, multi-center study (PRECEPT) which met primary safety and effectiveness endpoints and demonstrated 80 percent of persistent AF patients experienced clinical success at 15 months after ablation therapy using the THERMOCOOL SMARTTOUCH SF Catheter with the CARTO VISITAG™ Module. In addition, patients experienced clinically meaningful improvement in quality of life and the study showed significant reduction in healthcare resource utilization post-ablation.

Clinician comments

“Every patient and every arrhythmia are unique,” said Dr. Francis Marchlinski, Director of Electrophysiology, University of Pennsylvania Health System. “This approval and the PRECEPT data provide evidence to support a tailored approach using the CARTO® 3 System and THERMOCOOL SMARTTOUCH SF Catheter to treat persistent AF patients, who are more at risk for stroke and other complications from their AF.”

Company comments

“Persistent AF patients face a higher risk of complications such as stroke, heart failure, and death,” said Uri Yaron, Worldwide President of Biosense Webster, Inc. “This approval and data from the PRECEPT study help to further our commitment to advancing AF treatment, providing electrophysiologists with state-of-the-art options for their patients.”

Source: Biosense Webster, Inc.

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