Johnson & Johnson MedTech (J&J MedTech) has secured CE mark approval for its dual-energy Thermocool Smarttouch SF catheter to treat cardiac arrhythmias.
The dual-energy Thermocool Smarttouch SF catheter is an irrigated, contact-force sensing catheter powered by the Trupulse generator.
It features Carto 3 system for electro-anatomical mapping and tag indexing and will be compatible with Trupulse generator hardware in the first half of 2025.
The system allows electrophysiologists to switch between radiofrequency (RF) and pulsed-field (PF) energy in the same catheter.
The dual-energy Thermocool Smarttouch SF catheter is designed on the same platform as the widely used radiofrequency Thermocool Smarttouch SF catheter.
Johnson & Johnson MedTech electrophysiology president Jasmina Brooks said: “We know that each AFib procedure is different; having both RF and PF energy through one device will allow physicians to personalise each procedure based on patient anatomy and clinical need and offer a point-by-point workflow that many of our customers prefer.
“The dual-energy Thermocool Smarttouch SF catheter offers the benefit of both energy modes in one familiar device.
“We are pleased to bring forward this innovation to enable electrophysiologists to deliver safe and effective procedures for patients in Europe impacted by AFib.”
The safety and efficacy of the dual-energy Thermocool Smarttouch SF catheter was evaluated in the SmartfIRE interventional clinical trial.
The study evaluated the safety and efficacy of the dual energy catheter with the Trupulse generator, in treating paroxysmal atrial fibrillation (AFib).
In the study, 149 adult patients were enrolled with recurrent symptomatic atrial fibrillation after at least one antiarrhythmic drug (AAD) or patients who were not eligible for AAD.
Early results showed that the catheter resulted in a 100% acute success rate, with first-pass isolation achieved in 96.8% of veins.
In addition to CE Mark approval, the company is planning to expand the dual-energy Thermocool Smarttouch SF catheter to other regions worldwide.
Johnson & Johnson MedTech scientific affairs vice president Jennifer Currin said: “The SmartPulse and PulseSmart studies are part of a broad set of PFA clinical trials and diverse research initiatives that Johnson & Johnson MedTech is undertaking to generate the evidence necessary to guide informed treatment decisions, optimise clinical use, and ultimately enhance AFib treatment outcomes.”
