Johnson & Johnson MedTech has announced European CE mark approval of the Dual Energy Thermocool Smarttouch SF catheter for the treatment of cardiac arrhythmias.
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.
The Dual Energy Thermocool Smarttouch SF catheter is not currently approved in the USA. The Dual Energy Thermocool Smarttouch SF catheter is designed on the same platform as the radiofrequency Thermocool Smarttouch SF catheter
“As the number of people with atrial fibrillation (AF) 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, 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 customise 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 trial. Early results from 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.
“Based on our collaboration with electrophysiologists around the world, we know that each AF 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,” 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 effective procedures for patients in Europe impacted by AF.”
In addition to receiving European CE mark approval, the company is making progress to bring the Dual Energy Thermocool Smarttouch SF catheter to other regions of the world, a press release states.
The company has completed enrolment in the SmartPulse clinical trial—a prospective, single-arm, multicentre clinical study of 250 patients with paroxysmal atrial fibrillation (PAF) across 27 sites in the USA to evaluate the safety and effectiveness of the Dual Energy Thermocool Smarttouch SF catheter. The PulseSmart clinical trial, evaluating the Dual Energy Thermocool Smarttouch SF catheter in Australia and Canada, has also completed enrolment. This trial enrolled 136 patients with drug-refractory PAF across seven sites.
“The ability to deliver both PF and RF energy via the same catheter simplifies the workflow for ablation procedures and enables personalised treatment,” said Dhanunjaya Lakkireddy, executive medical director, Kansas City Heart Rhythm Institute, Kansas City, USA, who took part in the SmartPulse clinical trial. “In addition, the integration of the Dual Energy Thermocool Smarttouch SF catheter with the Carto 3 system can enable real-time catheter visualisation and feedback on contact force measurements and tag indexes, which are important factors for durable lesion formation.”
“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,” said Jennifer Currin, vice president, scientific affairs at Johnson & Johnson MedTech.
