Johnson & Johnson MedTech Gets CE Mark Approval for Dual Energy SF Catheter

The company expects TRUPULSE Generator hardware compatibility in the first half of 2025.

Ep Render De Stsf Image 07 (1) (1)
Johnson & Johnson MedTech

Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today 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.  

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.

Additional Studies Underway

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.  

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.

More in Cardiovascular