Johnson & Johnson (J&J) has secured approval from the US Food and Drug Administration (FDA) for its Dual Energy Thermocool Smarttouch SF Platform (DE STSF).
The system is designed to support electrophysiologists in performing catheter ablation by enabling delivery of both radiofrequency (RF) and pulsed field (PF) energy using a single catheter.
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It builds on the existing Thermocool Smarttouch SF technology, which J&J said has already been used to treat more than one million patients in the US.
The addition of pulse field capability allows the device to offer both RF and PF ablation through a familiar system for physicians.
The DE STSF platform is integrated with the CARTO ecosystem, incorporating advanced mapping, imaging, and PF Index guidance features.
J&J reports that this integration is intended to assist physicians in delivering energy with precise contact force while supporting a predictable procedure and repeatable workflow.
The dual-energy approach is designed to offer flexibility for clinicians to choose between RF and PF energy depending on patient anatomy and case requirements.
Following the FDA authorisation, J&J expects the first use of the DE STSF platform in the US to occur later this year, as the company begins a phased commercial rollout.
Johnson & Johnson MedTech electrophysiology and neurovascular company group chair Michael Bodner said: “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 US and continue building on the momentum of one of the most active innovation periods in our history.”
J&J earlier initiated enrolment in its SKYWARD investigational device exemption clinical programme to evaluate the Shockwave SkyRunner Carotid intravascular lithotripsy system.
