Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has approved the dual-energy ThermoCool SmartTouch SF platform (DE STSF)—an integrated catheter ablation solution that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through a single catheter.
“The US FDA approval of the DE STSF platform is another important milestone in what has been an incredible pace of innovation for our business,” said Michael Bodner, company group chair for electrophysiology and neurovascular at J&J MedTech. “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 USA and continue building on the momentum of one of the most active innovation periods in our history.”
Built on the ThermoCool SmartTouch SF platform, which has extensive clinical validation and has been used to treat more than one million patients in the USA—J&J states—the DE STSF platform “brings pulse field capability to a catheter physicians know and trust”.
The DE STSF platform is integrated with J&J’s Carto ecosystem, including advanced mapping, imaging and PF index guidance, helping physicians confidently deliver energy with precise contact force while supporting a predictable procedure and reproducible workflow, according to the company. The dual-energy capability also gives physicians the versatility to use RF or PF energy based on patient anatomy and case complexity.
“Electrophysiologists need technologies that support different anatomies, substrates, workflows and treatment goals,” commented Dhanunjaya Lakkireddy (The Kansas City Heart Rhythm Institute, Overland Park, USA). “The DE STSF platform gives electrophysiologists the choice to use RF or PF energy based on the needs of each procedure. Having both capabilities integrated in the Carto system can help us adapt our approach for more complex cases and plan procedures with greater confidence.”
Following this US FDA approval, the first US procedures with the DE STSF platform are expected to begin this summer as J&J initiates a phased commercial rollout.
