Johnson & Johnson wins FDA approval for dual energy ablation platform
Johnson & Johnson received FDA approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform, an integrated catheter ablation solution enabling electrophysiologists to deliver both radiofrequency and pulsed field energy through a single catheter. Integrated with the CARTO ecosystem, the platform allows physicians to tailor treatments based on patient anatomy and case complexity. The company will initiate a phased commercial rollout in the U.S., with the first procedures expected to begin this summer.
*this image is generated using AI for illustrative purposes only.
Johnson & Johnson 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. This approval allows physicians to tailor treatment based on patient anatomy and case complexity, expanding access to technology previously introduced in Europe. The platform is built on the THERMOCOOL SMARTTOUCH SF Platform, which has treated over one million patients in the U.S.
The DE STSF platform is integrated with the CARTO ecosystem, including advanced mapping, imaging, and PF Index guidance. This integration helps physicians confidently deliver energy with precise contact force while supporting a predictable procedure and reproducible workflow. The dual energy capability provides the versatility to use RF or PF energy based on specific clinical needs.
Clinical and Operational Benefits
The platform combines pulse field and radiofrequency energy in a single catheter, offering a comprehensive solution for electrophysiologists. The CARTO system integration supports complex case planning and execution.
| Feature | Description |
|---|---|
| Energy Types | Radiofrequency (RF) and Pulsed Field (PF) |
| Integration | CARTO ecosystem with advanced mapping and imaging |
| Guidance | PF Index guidance for precise energy delivery |
| Clinical Base | Built on THERMOCOOL SMARTTOUCH SF Platform |
Executive Commentary
"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."
Dhanunjaya (DJ) Lakkireddy, M.D., FHRS, MBA, Executive Medical Director at The Kansas City Heart Rhythm Institute, emphasized the clinical utility of the dual energy approach. "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."
Commercial Rollout
Following the FDA approval, Johnson & Johnson will initiate a phased commercial rollout. First U.S. procedures with the DE STSF Platform are expected to begin this summer.
How will the phased commercial rollout strategy impact the platform's market penetration over the next 12 months?
What are the potential reimbursement challenges for this dual-energy technology compared to single-energy solutions?
How might competitors respond to this approval with their own multi-energy ablation systems?
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