FDA approves Johnson & Johnson's dual-energy cardiac ablation catheter combining radiofrequency and pulsed field technology

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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