Johnson & Johnson Gets FDA Nod for Integrated Catheter Ablation Platform

July 8, 2026 — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) approved the Dual Energy ThermoCool SmartTouch SF Platform (DE STSF), an integrated catheter ablation solution that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through a single catheter.ⁱ

“The FDA approval of the Dual Energy ThermoCool SmartTouch SF Platform is another important milestone in what has been an incredible pace of innovation for our business,” said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson. “Our goal has always been to put the best possible technologies into physicians’ hands so they can treat increasingly complex cases with confidence. Following a successful introduction in Europe, we’re pleased to rapidly expand access to this technology in the U.S. and continue building on the momentum of one of the most active innovation periods in our history.”

Single Catheter

Built on the ThermoCool SmartTouch SF Platform, which has extensive clinical validation and has treated over one million patients in the U.S, the DE STSF Platform brings pulse field capability to a catheter physicians know and trust.ⁱ

The DE STSF platform is integrated with the CARTO ecosystem, including advanced mapping, imaging and PF Index guidance, helping physicians confidently deliver energy with precise contact force while supporting a predictable procedure and reproducible workflow. The dual energy capability gives physicians the versatility to use RF or PF energy based on patient anatomy and case complexity.ⁱ

“Electrophysiologists need technologies that support different anatomies, substrates, workflows and treatment goals,” said Dhanunjaya (DJ) Lakkireddy¹, M.D., FHRS, MBA, Executive Medical Director, The Kansas City Heart Rhythm Institute. “The Dual Energy Thermocool Smarttouch SF Platform gives electrophysiologists the choice to use RF or PF energy based on the needs of each procedure. Having both capabilities integrated in the CARTO system can help us adapt our approach for more complex cases and plan procedures with greater confidence.”

Following FDA approval, first U.S. procedures with the DE STSF Platform are expected to begin this summer as Johnson & Johnson initiates a phased commercial rollout.

¹ Dr. Lakkireddy serves as a consultant for Johnson & Johnson. Dr. Lakkireddy was not compensated for this authorship contribution.
ⁱ Mattias Duytschaever, Gediminas Račkauskas, Tom De Potter, et al. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results EP Europace, Volume 26, Issue 5, May 2024, euae088, ttps://doi.org/10.1093/europace/euae088