Biosense Webster, a part of Johnson & Johnson MedTech, has completed the treatment of first patients using its investigational Dual Energy Thermocool Smarttouch SF Catheter and the Trupulse Generator.
The first patients were treated as part of the SmartPulse, a single-arm, multi-centre, clinical study designed to enroll around 250 patients with paroxysmal atrial fibrillation (AFib) in the US.
It aims to determine the safety and effectiveness of Biosense Webster’s dual energy pulsed field (PFA)/radiofrequency (RF) ablation system for the isolation of atrial pulmonary veins.
Memorial Health University clinical cardiac electrophysiologist David Newton and Texas Cardiac Arrhythmia Institute, St. David’s Medical Centre executive medical director Andrea Natale performed the first procedures.
Andrea Natale said: “The SmartPulse pivotal trial will allow us to learn more about the promise of PFA in paroxysmal AFib. The Dual Energy STSF Catheter is an exciting innovation because it allows customization of treatment by switching between radiofrequency and pulsed-field energy.
“The ability to deliver both types of energy via one catheter simplifies the workflow for ablation procedures, while integration with the CARTO 3 Mapping System enables real-time catheter visualization and feedback on contact force measurements and ablation indexes – important factors for durable lesion formation.”
The Dual Energy Thermocool Smarttouch SF Catheter (Dual Energy STSF) is an investigational focal, contact force sensing catheter that can deliver both RF and PFA energy.
The Trupulse Generator is intended to provide both the RF energy and PFA energy to the catheter through the toggling of the two energy sources on the generator monitor.
The catheter and the generator are integrated with the CARTO 3 Mapping System to facilitate accurate 3D visualisation with minimal fluoroscopy for electrophysiologists (EPs) and staff.
In addition, the platform integrates contact force measurement and ablation indexes for RF and PFA, which are proven to be critical for lesion creation.
The Dual Energy STSF Catheter and the Trupulse Generator are currently under development and are not available for sale in any region of the world.
Biosense Webster president Jasmina Brooks said: “The Thermocool Smarttouch SF Catheter is the most commonly used ablation catheter globally.
“By bringing the benefits of RF and PFA to a single catheter that EPs are accustomed to, we are giving physicians control of their preferred energy source and offering a point-by-point workflow that many prefer.
“SmartPulse is the latest study in a robust global clinical trial program for the Biosense Webster investigational PFA portfolio aimed at ensuring our differentiated platform gives EPs the tools and information they need in real-time to deliver the best possible patient care.”
Earlier this year, Biosense Webster completed the enrolment of the SmartfIRE study, which is evaluating the safety and efficacy of the Dual Energy STSF Catheter in Europe.
