FDA approves J&J's dual energy catheter combining RF, pulsed field ablation

The U.S. Food and Drug Administration has approved Johnson & Johnson's Dual Energy Thermocool Smarttouch SF Platform (DE STSF), an integrated catheter ablation system that allows electrophysiologists to deliver both radiofrequency and pulsed field energy through a single catheter, the company announced.

The approval follows a launch in Europe and marks what Johnson & Johnson MedTech describes as another step in an active period of innovation for its electrophysiology and neurovascular business.

"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."

The DE STSF Platform is built on the existing Thermocool Smarttouch SF Platform, a catheter the company said has extensive clinical validation and has been used to treat more than 1 million patients in the U.S. The new platform adds pulsed field capability to that established device rather than introducing an entirely new catheter to physicians' workflows.

The system is integrated with Johnson & Johnson's Carto ecosystem, incorporating mapping, imaging and PF Index guidance intended to help physicians deliver energy with precise contact force while supporting a predictable, reproducible procedure. The dual energy design is meant to give electrophysiologists the flexibility to choose RF or PF energy depending on a patient's anatomy and the complexity of the case, rather than requiring a separate catheter for each energy type.

Dhanunjaya (DJ) Lakkireddy, M.D., executive medical director of the Kansas City Heart Rhythm Institute, said the flexibility addresses a real gap in current pulsed field ablation tools. "Electrophysiologists need technologies that support different anatomies, substrates, workflows and treatment goals," Lakkireddy said. "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."

Johnson & Johnson said the first U.S. procedures using the DE STSF Platform are expected to begin this summer, as the company begins a phased commercial rollout.

The approval adds to a busy stretch of dealmaking and product launches in J&J's cardiac ablation business. The company's cardiac ablation portfolio has expanded significantly in recent months as it competes for share in a market being reshaped by pulsed field technology.

Pulsed field ablation's growing footprint in electrophysiology

The DE STSF approval lands amid a broader industry shift toward pulsed field ablation as an alternative or complement to traditional thermal ablation techniques in treating atrial fibrillation and other arrhythmias. Unlike RF or cryoablation, which rely on heat or cold to destroy arrhythmogenic tissue, pulsed field ablation uses short high-voltage electrical pulses to create nanopores in cell membranes, a process known as irreversible electroporation.

Proponents of the technology have pointed to its tissue selectivity as a potential safety advantage, since PF energy is designed to spare structures such as the esophagus, phrenic nerve and pulmonary veins that can be vulnerable to thermal injury during RF or cryoablation procedures. Multiple device makers have pursued PF-capable systems over the past several years, and demand for supporting components — from mapping software to specialized catheter connectors — has grown alongside adoption.

For hospital systems and electrophysiology labs, the emergence of dual energy platforms like DE STSF reflects a practical response to that shift: rather than stocking and training staff on entirely separate RF and PF systems, a single catheter that can toggle between energy types may simplify inventory, procedural planning and physician training. Whether that convenience translates into measurable improvements in procedural time, complication rates or long-term arrhythmia-free outcomes will likely be a focus of post-market data as U.S. adoption begins this summer.