FDA Approves Johnson & Johnson's Dual-Energy Catheter Ablation Platform

The DE STSF platform combines radiofrequency and pulsed field ablation in a single catheter, expanding treatment options for electrophysiologists managing complex cardiac arrhythmias.

Johnson & Johnson has received US Food and Drug Administration (FDA) approval for its Dual Energy Thermocool Smarttouch SF (DE STSF) platform, a catheter ablation system that enables physicians to deliver both radiofrequency (RF) and pulsed field (PF) energy using a single device.

The approval expands the company's electrophysiology portfolio by giving clinicians greater flexibility to tailor ablation strategies based on individual patient anatomy and procedural requirements.

Dual-Energy Approach to Catheter Ablation

The DE STSF platform builds on Johnson & Johnson's established Thermocool Smarttouch SF technology, which the company says has been used to treat more than one million patients in the United States.

The addition of pulsed field ablation allows physicians to choose between two different energy sources during procedures:

• Radiofrequency (RF) ablation, which uses heat to destroy abnormal cardiac tissue.

• Pulsed field (PF) ablation, a newer, non-thermal technology that selectively targets cardiac cells using electrical pulses.
  

Providing both options through a single catheter is intended to simplify workflows while allowing clinicians to adapt treatment to different clinical scenarios.

Integrated with the CARTO Platform

The DE STSF system is fully integrated with Johnson & Johnson's CARTO mapping ecosystem.

The platform combines advanced cardiac mapping, imaging capabilities and PF Index guidance to help physicians visualise anatomy and accurately deliver ablation therapy.

According to the company, the integrated system is designed to support precise catheter contact, predictable energy delivery and more consistent procedural workflows.

Commercial Rollout Planned for Later This Year

Following FDA approval, Johnson & Johnson expects the first US procedures using the DE STSF platform to take place later this year as part of a phased commercial launch.

The approval follows the technology's earlier introduction in Europe, where the platform has already entered clinical use.

Company executives said the launch represents another milestone during a period of significant innovation within the electrophysiology market.

Growing Innovation in Cardiac Electrophysiology

Demand for advanced catheter ablation technologies continues to increase as physicians seek safer, more effective treatments for cardiac arrhythmias such as atrial fibrillation.

Pulsed field ablation has emerged as one of the fastest-growing technologies in electrophysiology due to its potential to reduce damage to surrounding tissue while maintaining procedural effectiveness.

Johnson & Johnson continues to expand its cardiovascular device portfolio, having recently initiated enrolment in its SKYWARD investigational device exemption study evaluating the Shockwave SkyRunner Carotid intravascular lithotripsy system.

Why the Approval Matters

The FDA approval reflects several key trends across cardiovascular medical technology:

• Dual-energy ablation systems are providing physicians with greater procedural flexibility.

• Pulsed field ablation continues to gain momentum as a next-generation treatment approach.

• Integration of mapping, imaging and navigation technologies is improving procedural precision.

• Competition within the electrophysiology market is accelerating as manufacturers expand their cardiac device portfolios.
  

Summary

Johnson & Johnson has secured FDA approval for its Dual Energy Thermocool Smarttouch SF platform, enabling physicians to perform both radiofrequency and pulsed field catheter ablation using a single system.

Integrated with the CARTO ecosystem, the platform offers greater flexibility for treating complex cardiac arrhythmias and further strengthens Johnson & Johnson's position in the rapidly evolving electrophysiology market.

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