Johnson & Johnson just scored FDA approval for its Dual Energy Thermocool Smarttouch SF Platform — a single catheter that delivers both radiofrequency (RF) and pulsed field ablation (PFA) energy for treating atrial fibrillation. The platform integrates with J&J's existing CARTO mapping system and is indicated for refractory, recurrent symptomatic paroxysmal or persistent AF. Trial data showed a 100% acute success rate in paroxysmal AF patients.
Johnson & Johnson has received FDA approval for its Dual Energy Thermocool Smarttouch SF Platform, a catheter ablation system that combines radiofrequency (RF) and pulsed field ablation (PFA) energy in a single device. The platform integrates with J&J's CARTO mapping, imaging, and pulsed field index guidance system, and is indicated for patients with refractory, recurrent symptomatic paroxysmal or persistent atrial fibrillation (AF).
The approval was supported by 3-month results from the SmartfIRE trial, published in EP Europace, which demonstrated a 100% acute success rate in treating paroxysmal AF, with acceptable safety and durable pulmonary vein isolation at the 3-month mark.
Key Takeaways:
Why it matters: AF ablation is one of the most commonly performed cardiac procedures, and having both energy modalities in one catheter could streamline workflows, reduce equipment burden, and improve outcomes for patients with complex or refractory AF — a meaningful step forward for electrophysiologists.
