The irrigated, contact-force sensing catheter features alongside the TruPulse generator. Both offer full integration with the Carto 3 electro-anatomical mapping system.
Johnson & Johnson MedTech expects to have TruPulse generator hardware compatibility available in the first half of 2025. When fully approved, it expects the system to provide the ability to switch between RF and PF energy. The catheter remains investigational in the U.S.
Results from its SmartfIRE clinical trial presented in April demonstrated 100% acute procedural success during standard electrophysiology mapping and ablation procedures. That study looked at drug-refractory symptomatic paroxysmal AFib patients. Additionally, investigators said 96.8% of patients showed no acute reconnections in the veins.
J&J MedTech has additional studies underway to bring the catheter to other geographies, including the U.S. News of this clearance comes days after the company paused all U.S. cases using its Varipulse PFA system in the U.S.
“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.”
