Biosense Webster has announced the first cases with its investigational Thermocool Smarttouch SF dual energy catheter have taken place as part of the SmartfIRE Study.
The first procedure was performed by Tom De Potter at OLV Hospital in Aalst, Belgium. Several additional cases were performed by Mattias Duytschaever at AZ Sint-Jan Brugge Oostende AV in Brugge, Belgium, which is also taking part in the clinical trial.
SmartfIRE is a pivotal, prospective, multicentre, single-arm study that will enrol approximately 135 patients in Europe to evaluate the safety and effectiveness of Biosense Webster’s dual energy pulsed field (PF)/radiofrequency (RF) ablation system. The study will evaluate the system for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (AF) during standard electrophysiology mapping and ablation procedures.
“While radiofrequency ablation has decades of safety and efficacy data to support it, pulsed field ablation is a novel technology that shows promise in advancing the safety and ease of catheter ablation procedures; the versatility of a dual-energy catheter would give electrophysiologists the choice of using either one or both modalities at their fingertips,” said De Potter, who conducted the first case. “In caring for patients with AF, my goal is to deliver a treatment that is maximally safe and efficient at the same time, and this dual-energy system may give me the ability to switch between radiofrequency and pulsed field and customize treatment during a procedure to deliver the most appropriate energy.’’
The principal components of the ablation system to be evaluated in this investigation are the Thermocool Smarttouch SF dual energy catheter and the Trupulse generator. The Thermocool Smarttouch SF bi-directional navigation catheter with contact force sensing capability, is a steerable, multi-electrode luminal, irrigated catheter. It is CE marked for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a RF generator, for cardiac ablation.
The investigational Trupulse generator provides both the RF energy and the novel unipolar, biphasic pulse sequence to the catheter through the toggling of the two energy sources on the generator monitor.
The Thermocool Smarttouch SF catheter is to be used in this investigational study with the Trupulse generator, to transmit the PF or RF energy to the catheter tip electrode for cardiac ablation. The catheter and the generator are integrated with the Carto 3 system. The Thermocool Smarttouch SF dual energy catheter and the Trupulse generator are not available for sale in any region.