Johnson & Johnson MedTech (NYSE: JNJ) announced its dual-energy ThermoCool SmartTouch SF catheter has achieved CE mark certification. The catheter, characterized by its irrigated, contact force-sensing features, collaborates with the TruPulse generator, both of which fully integrate with the Carto 3 electro-anatomical mapping system.
The company anticipates that by the first half of 2025, the TruPulse generator hardware will be compatible. Upon complete approval, the system is expected to facilitate transitions between RF and PF energy types. As of now, the catheter remains under investigation within the United States.
Presented in April, outcomes from the SmartfIRE clinical trial indicated a remarkable 100% acute procedural success in standard electrophysiology mapping and ablation procedures. This particular research focused on patients with drug-refractory symptomatic paroxysmal AFib. Additionally, 96.8% of those patients experienced exceptional results with no acute reconnections in the veins.
J&J MedTech is actively conducting further investigations to expand the catheter’s reach to broader regions, including the U.S. This recent approval follows closely on the heels of the company’s decision to suspend all U.S. operations involving its Varipulse PFA system.
Reflecting on their global collaboration with electrophysiologists, Jasmina Brooks, President of Electrophysiology at Johnson & Johnson MedTech, noted, “We understand that every AFib procedure presents its unique challenges; having the flexibility of RF and PF energy in a single device allows physicians to tailor each intervention to the patient’s anatomy and clinical scenario. This offers a point-by-point workflow, greatly appreciated by our clientele. The dual-energy ThermoCool SmartTouch SF catheter facilitates the combination of both energy types within a single familiar apparatus. We are excited to introduce this advancement to aid electrophysiologists in administering safe and efficient treatments for AFib patients across Europe.”