BioSense Webster’s Thermocool SmartTouch Catheter Gets FDA Approval

Subsidiary of Johnson & Johnson, Biosense Webster, was granted FDA premarket approval for its Thermocool SmartTouch SF catheter designed for ablation procedures.

The catheter is designed to be integrated into the company’s Carto 3 system.

Data from a clinical study of the device indicated a success rate of greater than 80 percent with no unanticipated adverse events. — Cynthia Jessup