Johnson & Johnson gains CE mark approval for catheter capable of radiofrequency, PFA ablation
Johnson & Johnson MedTech has received CE mark approval for its Dual Energy ThermoCool SmartTouch SF Catheter for treating patients with cardiac arrhythmias.
The device help users switch between radiofrequency and pulsed field ablation (PFA) energy with a single catheter. Johnson & Johnson MedTech designed it to work with the company’s TruPulse Generator and Carto 3 System.
The new catheter has not yet been approved by the U.S. Food and Drug Administration (FDA), but it was designed on the same platform as the radiofrequency Thermocool SmartTouch SF Catheter.
In April 2024, Johnson & Johnson MedTech—still going by the name Biosense Webster at the time—shared early results from the SmartfIRE clinical trial, which linked treatment with the new catheter with a 100% acute success rate and first-pass isolation in 96.8% of veins.
“Based on our collaboration with electrophysiologists around the world, we know that each atrial fibrillation (AFib) procedure is different. Having both radiofrequency and PFA 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,” Jasmina Brooks president of electrophysiology for Johnson & Johnson MedTech, said in a statement. “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.”
A study is already underway to track the safety and effectiveness of the Dual Energy ThermoCool SmartTouch SF Catheter in approximately 250 U.S. patients with paroxysmal AFib. Johnson & Johnson MedTech hopes to use data from that trial to gain FDA approval.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.