IRVINE, Calif., July 8, 2026
Johnson & Johnson MedTech has announced that the U.S. Food and Drug Administration (FDA) has approved the Dual Energy THERMOCOOL SMARTTOUCH SF (DE STSF) Platform, a next-generation catheter ablation system that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through a single catheter. The approval marks a significant advancement in the treatment of cardiac arrhythmias, providing physicians with greater procedural flexibility while simplifying workflow during complex ablation procedures. Fully integrated with the CARTO™ mapping ecosystem, the innovative platform combines advanced three-dimensional mapping, imaging, contact force sensing, and pulse field guidance to support highly precise catheter navigation and energy delivery. Following a successful commercial introduction in Europe, Johnson & Johnson plans to begin a phased rollout across the United States later this summer, expanding access to one of the company’s most advanced electrophysiology technologies.
Dual-Energy Platform Expands Catheter Ablation Capabilities
The Dual Energy THERMOCOOL SMARTTOUCH SF Platform builds upon the widely adopted THERMOCOOL SMARTTOUCH SF catheter, which has already been used to treat more than one million patients in the United States. The newly approved platform integrates radiofrequency ablation, the long-established standard for cardiac tissue ablation, with pulsed field ablation, an emerging non-thermal technology designed to selectively target cardiac tissue while minimizing damage to surrounding anatomical structures. By offering both energy modalities within a single catheter, physicians can tailor treatment strategies according to individual patient anatomy, disease complexity, and procedural objectives without changing devices.
Integration with the CARTO ecosystem provides advanced mapping, imaging, and PF Index guidance, helping electrophysiologists accurately position the catheter, maintain optimal tissue contact, and deliver energy with greater precision and procedural consistency. This combination is expected to improve workflow efficiency while supporting reproducible outcomes across a wide range of complex electrophysiology procedures.
FDA Approval Strengthens Innovation in Cardiac Electrophysiology
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The FDA approval reinforces Johnson & Johnson MedTech’s continued investment in advancing cardiac rhythm management technologies and minimally invasive cardiovascular care. Electrophysiologists increasingly require flexible treatment solutions capable of addressing varying cardiac anatomies and complex arrhythmia substrates, particularly as pulsed field ablation gains broader clinical adoption. By combining two complementary ablation technologies into one integrated platform, the Dual Energy THERMOCOOL SMARTTOUCH SF Platform enables physicians to select the most appropriate energy source during each procedure while maintaining compatibility with existing clinical workflows. Clinical experts believe the technology has the potential to improve procedural planning, enhance physician confidence, and support treatment of increasingly complex arrhythmia cases.
Johnson & Johnson expects the first commercial U.S. procedures using the FDA-approved platform to begin during the summer of 2026, further expanding access to advanced electrophysiology solutions nationwide. The FDA approval represents another major milestone in the evolution of catheter ablation technology, highlighting Johnson & Johnson’s commitment to developing innovative cardiovascular solutions that combine precision, flexibility, and procedural efficiency for physicians treating patients with heart rhythm disorders. As demand continues to grow for advanced minimally invasive cardiac therapies, the dual-energy platform is positioned to play an important role in the future of electrophysiology, atrial fibrillation treatment, and next-generation cardiac ablation technologies.
Source: Johnson & Johnson press release
