Johnson & Johnson MedTech has announced European CE mark approval for its innovative Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter, designed for the treatment of cardiac arrhythmias. This device marks a significant advancement in the field by integrating radiofrequency (RF) and pulsed field (PF) energy in a single catheter. This capability allows electrophysiologists to switch energy modes seamlessly during procedures, enhancing the flexibility and effectiveness of treatments for paroxysmal atrial fibrillation (AFib).
The CE Mark approval was supported by the results of the SmartfIRE clinical study, which demonstrated the safety and efficacy of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter in treating AFib. The catheter is part of an integrated system that includes the TRUPULSE™ Generator and is fully compatible with the CARTO™ 3 System for precise electro-anatomical mapping. Johnson & Johnson MedTech anticipates TRUPULSE™ Generator hardware compatibility by the first half of 2025, further enhancing the system’s capabilities.
In addition to its regulatory success, Johnson & Johnson MedTech has completed enrollment in the SmartPulse and PulseSmart clinical trials, further evaluating the catheter in various international settings. These studies aim to expand the clinical evidence supporting the use of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and its unique dual energy capability, which simplifies procedural workflows and offers personalized treatment options for patients with cardiac arrhythmias.
