Johnson & Johnson MedTech has received US Food and Drug Administration (FDA) approval for its Dual Energy THERMOCOOL SMARTTOUCH SF (DE STSF) Platform, an integrated catheter ablation system that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy using a single catheter.
The platform is integrated with the CARTO ecosystem, combining advanced mapping, imaging, and PF Index guidance to help physicians deliver energy with precise contact force. The company said it is designed to support predictable procedures, reproducible workflows, and give physicians the flexibility to choose either RF or PF energy based on patient anatomy and case complexity.
Following FDA approval, Johnson & Johnson plans to begin first US procedures with the DE STSF Platform this summer as part of a phased commercial rollout.
“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.
Dhanunjaya (DJ) Lakkireddy, executive medical director, The Kansas City Heart Rhythm Institute, said Electrophysiologists require technologies that support different anatomies, substrates, workflows and treatment goals.
“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,” he added.
Johnson & Johnson MedTech had previously received the European CE Mark for the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in January 2025 for the treatment of cardiac arrhythmias. The catheter is built on the same platform as the company’s radiofrequency THERMOCOOL SMARTTOUCH SF Catheter.
Catheter Ablation for Cardiac Arrhythmias
Catheter ablation is a minimally invasive procedure performed by electrophysiologists to treat heart rhythm disorders, including atrial fibrillation (AFib), by interrupting irregular electrical pathways in the heart. Clinical evidence has shown that catheter ablation can be more than four times more effective than antiarrhythmic drug therapy alone in preventing recurrent arrhythmias in patients with AFib.
Radiofrequency ablation (RFA), introduced approximately three decades ago, remains the standard approach for cardiac ablation. It uses radio waves to generate heat and destroy the tissue responsible for abnormal electrical signals. The procedure is primarily indicated for treating patients with AFib whose symptoms are not adequately controlled with medication.
Pulsed field ablation (PFA), a newer technology introduced commercially in Europe in 2021 and in the United States in 2023, uses rapid electrical pulses to create microscopic pores in targeted heart cells. This process disrupts cell integrity, ultimately leading to selective tissue destruction while preserving surrounding structures.
The Dual Energy THERMOCOOL SMARTTOUCH SF Platform comprises the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter, an irrigated contact-force sensing catheter, and the TRUPULSE Generator, which allows physicians to switch between RF and PF energy through a single interface. The system is fully integrated with the CARTO 3 System, enabling real-time three-dimensional cardiac mapping and advanced visualization during ablation procedures.
