J&J MedTech’s Dual Energy Catheter Approved

The Dual Energy  Thermocool Smarttouch SF Catheter is an irrigated, contact-force sensing catheter powered by the Trupulse  Generator, and is fully integrated with the Carto 3 System for electro-anatomical mapping and for tag indexing. The company expects Trupulse  Generator hardware compatibility in the first half of 2025. When fully approved, the platform will provide electrophysiologists with the ability to switch between radiofrequency (RF) and pulsed field (PF) energy in the same catheter they know and trust. The Dual Energy  Thermocool Smarttouch SF Catheter is not currently approved in the United States. The Dual Energy  Thermocool Smarttouch SF Catheter is designed on the same platform as the radiofrequency  Thermocool Smarttouch SF Catheter – the most commonly used catheter in the world today, with many years of physician experience.

As the number of people with AFib grows around the world, physicians are looking for integrated and flexible tools to help deliver safe, effective and efficient cardiac ablation procedures,” said Tom De Potter, M.D., Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium.ⁱ “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.”

The safety and efficacy of the Dual Energy Thermocool Smarttouch SF Catheter was investigated in the SmartfIRE clinical trial² Early results from the study, published in April 2024, ( see citation) showed that the use of the catheter led to a 100% acute success rate, with first-pass isolation achieved in 96.8% of veins.

“Based on our collaboration with electrophysiologists around the world, we know that each AFib procedure is different; having both RF and PF energy through one device will allow physicians to personalize each procedure based on patient anatomy and clinical need and offer a point-by-point workflow that many of our customers prefer,” said Jasmina Brooks, President, Electrophysiology, Johnson & Johnson MedTech. “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 effect.

Citation: "Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results"- Mattias Duytschaever, Gediminas Račkauskas, Tom De Potter, Jim Hansen, Sebastian Knecht, Thomas Phlips, Johan Vijgen, Daniel Scherr, Gabor Szeplaki, Hugo Van Herendael ... EP Europace, Volume 26, Issue 5, May 2024, euae088, https://doi.org/10.1093/europace/euae088.