The FDA has approved Johnson & Johnson's Dual Energy Thermocool Smarttouch SF Platform, a cardiac ablation system that allows electrophysiologists to switch between radiofrequency and pulsed field energy using a single catheter. Integrated with the Carto mapping system, the platform aims to simplify complex atrial fibrillation procedures. Supported by clinical data showing a 100% acute success rate in the SmartfiRE study, J&J plans a phased U.S. commercial rollout starting in the summer of 2026 to compete with rivals like Boston Scientific and Medtronic.
FDA approval dual-energy catheter
- ▪The Dual Energy Thermocool Smarttouch SF Platform is built on Johnson & Johnson's existing Thermocool Smarttouch SF platform, which has treated more than 1 million patients in the United States
- ▪The U.S. Food and Drug Administration approved Johnson & Johnson's Dual Energy Thermocool Smarttouch SF Platform (DE STSF) for treating atrial fibrillation
Radiofrequency pulsed field switching
- ▪The dual-energy capability allows electrophysiologists to switch between radiofrequency and pulsed field energy in a single catheter based on patient anatomy and case complexity
- ▪The Dual Energy Thermocool Smarttouch SF Platform combines the irrigated contact-force-sensing ThermoCool SmartTouch SF catheter with the TruPulse generator to deliver both radiofrequency and pulsed field energy through a single catheter
SmartfiRE study acute success
- ▪The SmartfiRE study for paroxysmal atrial fibrillation, which supported the CE mark approval, showed a 100% acute success rate with first-pass isolation in 96.8% of veins in early results published in April 2024
- ▪Johnson & Johnson received a CE mark for the dual-energy Thermocool catheter in January 2025 and began its first cases in Europe later that year
Carto ecosystem integration features
- ▪The Carto system integration enables a point-by-point workflow and incorporates ultra-high-density mapping solutions and intracardiac ultrasound imaging
- ▪The Dual Energy Thermocool Smarttouch SF Platform integrates with Johnson & Johnson's Carto mapping system to provide advanced electro-anatomical mapping, catheter visualization, contact-force feedback, and PF/RF Index guidance
Competitive pulsed field ablation
- ▪Boston Scientific and Medtronic entered the pulsed field ablation market before Johnson & Johnson, which temporarily paused U.S. cases of its Varipulse PFA device to investigate four neurovascular events
- ▪The pulsed field ablation market includes competing technologies such as Boston Scientific's Farapulse, Medtronic's PulseSelect, Abbott's Volt, and Johnson & Johnson's Varipulse
U.S. commercial rollout timeline
- ▪Johnson & Johnson is launching the Dual Energy Thermocool Smarttouch SF Platform in the United States through a phased commercial rollout
- ▪Johnson & Johnson expects the first U.S. clinical procedures using the Dual Energy Thermocool Smarttouch SF Platform to begin in the summer of 2026
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