Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, 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 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. “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 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 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 effective procedures for patients in Europe impacted by AFib.”
In addition to receiving European CE Mark approval, the company is making strides to bring the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter to other regions of the world.
The company has completed enrollment in the SmartPulse clinical trial – a prospective, single arm, multi-center clinical study of 250 patients with paroxysmal atrial fibrillation (PAF) across 27 sites in the United States 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 enrollment. This trial enrolled 136 patients with drug-refractory PAF across 7 sites.
“The ability to deliver both PF and RF energy via the same catheter simplifies the workflow for ablation procedures and enables personalized treatment,” said Dr. Dhanunjaya (DJ) Lakkireddy, executive medical director, Kansas City Heart Rhythm Institute, who took part in the SmartPulse clinical trial. “In addition, the integration of the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter with the CARTO System can enable real-time catheter visualization 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, optimize clinical use, and ultimately enhance AFib treatment outcomes,” said Jennifer Currin, Ph.D., vice president, scientific affairs at Johnson & Johnson MedTech.
Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart. Catheter ablation can be more than four times more effective than antiarrhythmic drugs alone in preventing recurrent arrhythmia in AFib patients.
In addition to the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter, Johnson & Johnson MedTech is committed to offering a portfolio of products designed to work seamlessly together for optimal efficiency and compatibility in the treatment of cardiac arrhythmias.
The Dual Energy THERMOCOOL SMARTTOUCH SF Platform consists of the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter – an irrigated, contact-force sensing catheter – and the TRUPULSE Generator, providing both RF and PF energy to the catheter through the toggling of the two energy sources on the generator monitor. The catheter and the generator are fully integrated with the world’s leading CARTO 3 System, enabling live 3D mapping and advanced visualization during ablation procedures. The Dual Energy THERMOCOOL SMARTTOUCH SF Catheter is the first dual energy pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated with a PF and RF tag index.
SmartfIRE is an open-label interventional study evaluating the safety and efficacy of the investigational Dual Energy THERMOCOOL SMARTTOUCH SF Catheter with the TRUPULSE Generator, in the treatment of paroxysmal atrial fibrillation. The study enrolled 149 adult patients in Europe with drug refractory paroxysmal AFib, identified as candidates for catheter ablation, who received (PF) or (RF) catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE generator during their cardiac ablation procedure. The study includes patients experiencing recurrent symptomatic atrial fibrillation following at least one antiarrhythmic drug (AAD; class I to IV), or patients who can either not tolerate AAD or for whom AAD is contraindicated.