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J&J Snags CE Mark for Thermocool Smarttouch SF CatheterJ&J Snags CE Mark for Thermocool Smarttouch SF Catheter
The catheter is designed with the ability to switch between radiofrequency (RF) and pulsed field (PF) energy.
Susan Shepard
January 31, 2025
2 Min Read
Johnson & Johnson's dual energy Thermocool Smarttouch SF device is designed to switch between radiofrequency and pulsed field energy in the same catheter.Image courtesy of Johnson & Johnson
Electrophysiologists in Europe can now switch between radiofrequency and pulsed field energy in a single, fully integrated catheter when they use Johnson & Johnson’s dual energy Thermocool Smarttouch SF device.
The New Brunswick, NJ-based company received CE mark approval for the device for the treatment of cardiac arrhythmias. The CE mark is supported by the SmartfiRE study for the treatment of paroxysmal atrial fibrillation (AF). Early results of the study published in April 2024 showed that the use of the catheter led to a 100% acute success rate, with first-pass isolation achieved in 96.8% of veins.
Thermocool Smarttouch is an irrigated, contact-force sensing catheter powered by the company’s Trupulse generator, and it is the only dual-energy catheter fully integrated with the Carto 3 system for electro-anatomical mapping and for tag indexing. The company said it expects Trupulse generator hardware compatibility with the catheter in the first half of 2025.
“The ability to switch between radiofrequency (RF) and pulsed field (PF) energy in the same catheter offers flexibility, allowing the electrophysiologist (EP) to adapt in the moment,” Jass Brooks, president of electrophysiology at Johnson & Johnson MedTech, told MD+DI. “Dual-energy catheters enable EPs to customize procedures based on the individual needs of their patients and complexity of the procedure.”
Before the release of this device, a physician would need to use a separate catheter and generator to deliver either RF or PF energy, which would add time, complexity, and cost to the procedure, Brooks said. “Electrophysiologists in Europe will now have the ability to easily switch between RF and PF energy in a singular device, enabling more targeted ablation to manage complex arrythmias and delivering precise, real-time tissue contact force with lesion index information."
The dual-energy Thermocool Smarttouch SF catheter is designed on the same platform as the RF version of the catheter, which Brooks said is the most commonly used catheter in the world today, with many years of physician experience.
When will the Thermocool Smarttouch SF catheter be available in the US?
“We have completed enrollment in the SmartPulse clinical trial—a prospective single-arm, multicenter study involving 250 patients with paroxysmal AFib across 27 U.S. sites,” Brooks said.
She said the company intends to use the data from this study to support a premarket approval application to FDA and noted that this marks a significant step toward that goal.
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