Johnson & Johnson MedTech has announced that its Dual Energy THERMOCOOL SMARTTOUCH SF Catheter has received European CE Mark approval for the treatment of cardiac arrhythmias. This innovative device integrates radiofrequency (RF) and pulsed field (PF) energy modalities into a single catheter, offering electrophysiologists enhanced flexibility during cardiac ablation procedures. The company anticipates full hardware compatibility with the TRUPULSE Generator in the first half of 2025.
The Dual Energy THERMOCOOL SMARTTOUCH SF Catheter is designed to be used with the CARTO 3 System for electro-anatomical mapping and tag indexing. It is based on the same platform as the radiofrequency THERMOCOOL SMARTTOUCH SF Catheter, already widely used in clinical practice. The dual-energy catheter is currently not approved for use in the United States.
Clinical Trial Evidence
The safety and efficacy of the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter were evaluated in the SmartfIRE clinical trial. Early results, published in April 2024, demonstrated a 100% acute success rate and first-pass isolation achieved in 96.8% of veins. These findings suggest the catheter's potential to improve outcomes in patients undergoing cardiac ablation for atrial fibrillation (AFib).
Physician Perspectives
According to Dr. Tom De Potter, Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium, "Both PF and RF energy have important advantages in clinical practice. With the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter, having the ability to easily switch between RF and PF energy provides the flexibility to customize treatment depending on the patient anatomy and clinical need, enabling electrophysiologists to perform more targeted ablation procedures which could lead to improved outcomes for patients."
Ongoing Clinical Studies
Johnson & Johnson MedTech is actively pursuing regulatory approvals in other regions. Enrollment has been completed in the SmartPulse clinical trial, a prospective, single-arm, multi-center study involving 250 patients with paroxysmal atrial fibrillation (PAF) across 27 sites in the United States. The PulseSmart clinical trial, conducted in Australia and Canada, has also completed enrollment, with 136 patients with drug-refractory PAF across 7 sites.
Dr. Dhanunjaya (DJ) Lakkireddy, Executive Medical Director, Kansas City Heart Rhythm Institute, who participated in the SmartPulse clinical trial, noted, "The ability to deliver both PF and RF energy via the same catheter simplifies the workflow for ablation procedures and enables personalized treatment. In addition, the integration of the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter with the CARTO System can enable real-time catheter visualization and feedback on contact force measurements and tag indexes, which are important factors for durable lesion formation."
About Atrial Fibrillation and Catheter Ablation
Atrial fibrillation (AFib) is a common heart rhythm disorder that affects millions worldwide. Catheter ablation is a minimally invasive procedure used to treat AFib by interrupting irregular electrical pathways in the heart. Studies suggest that catheter ablation can be more than four times more effective than antiarrhythmic drugs alone in preventing recurrent arrhythmia in AFib patients.
The Dual Energy THERMOCOOL SMARTTOUCH SF Platform includes the catheter itself and the TRUPULSE Generator, which provides both RF and PF energy. The system is fully integrated with the CARTO 3 System, enabling live 3D mapping and advanced visualization during ablation procedures.
