The ThermoCool SmartTouch platform combines the ThermoCool SmartTouch SF catheter with the TruPulse generator. Combining the irrigated contact-force-sensing catheter with TruPulse enables the delivery of both radiofrequency (RF) and pulsed field (PF) energy. It all takes place through a single catheter-based solution.
FDA approval comes on the heels of the European launch for ThermoCool SmartTouch SF, announced two weeks ago. Other companies are also looking to make their mark in dual-energy ablation, with Abbott advancing its TactiFlex Duo platform.
Johnson & Johnson built the DE STSF platform on its existing ThermoCool SmartTouch SF platform. It says the clinically validated system has treated more than 1 million patients in the U.S. Now, it offers pulsed field capabilities to a trusted catheter.
The dual-energy platform with Carto mapping combines a point-by-point workflow with the flexibility to tailor treatment approaches across a range of procedures. It leverages Carto integration, ultra-high-density mapping solutions and intracardiac ultrasound imaging. This enables the delivery of advanced electro-anatomical mapping, catheter visualization, contact-force feedback and PF/RF Index guidance.
With FDA approval secured, J&J expects the first U.S. procedures to begin this summer amid a phase commercial launch.
“The FDA approval of the Dual Energy ThermoCool SmartTouch SF platform is another important milestone in what has been an incredible pace of innovation for our business,” said Michael Bodner, company group chair, Electrophysiology & Neurovascular, MedTech, J&J. “Our goal has always been to put the best possible technologies into physicians’ hands so they can treat increasingly complex cases with confidence. Following a successful introduction in Europe, we’re pleased to rapidly expand access to this technology in the U.S. and continue building on the momentum of one of the most active innovation periods in our history.”
