Biosense Webster’s Thermocool SmartTouch SF dual-energy catheter permits the usage of each radio-frequency (RF) and pulse-field (PF) strategies in catheter ablation procedures. The SmartfIRE pivotal, potential, multi-center, single-arm research will consider such an strategy for the remedy of drug refractory symptomatic paroxysmal atrial fibrillation (AFib) throughout customary electrophysiology mapping and ablation procedures.
Minimally invasive catheter ablation treats coronary heart rhythm problems, together with AFib, by interrupting irregular electrical pathways within the coronary heart by delivering both warmth (RF ablation) or chilly (Cryoablation), in response to a press launch from Biosense Webster. PF ablation provides a brand new strategy to deal with AFib, utilizing a managed electrical subject to selectively ablate cardiac tissue that causes the irregular heartbeat by a course of known as irreversible electroporation (IRE). The method could assist scale back the chance of injury to surrounding tissues together with esophageal, pulmonary vein, and phrenic nerve damage, because it doesn’t depend on thermal results to ablate goal cardiac tissue.
The primary process utilizing the Thermocool SmartTouch SF twin power catheter the research was carried out by Tom De Potter, MD, FEHRA, affiliate director, Cardiovascular Heart, Division of Cardiology, Electrophysiology Part, OLV Hospital, Aalst, Belgium, and several other further circumstances have been dealt with by Dr. Mattias Duytschaever at AZ Sint-Jan Brugge Oostende AV in Brugge, Belgium, which can also be collaborating within the medical trial.
“Whereas radiofrequency ablation has a long time of security and efficacy information to assist it, pulse subject ablation is a novel know-how that reveals promise in advancing the protection and ease of catheter ablation procedures; the flexibility of a dual-energy catheter would give electrophysiologists the selection of utilizing both one or each modalities at their fingertips,” defined De Potter within the launch. “In caring for sufferers with AFib, my objective is to ship a remedy that’s maximally secure and environment friendly on the identical time, and this dual-energy system could give me the power to modify between radiofrequency and pulsed subject and customise remedy throughout a process to ship probably the most acceptable power.”
SmartfIRE will consider Thermocool SmartTouch SF’s principal parts: the dual-energy catheter and the TruPulse generator. The catheter utillizes bi-directional navigation and make contact with pressure sensing for a steerable, multielectrode luminal, irrigated system. The catheter is CE marked to be used in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a RF generator, for cardiac ablation.
On this investigational research, the dual-energy catheter is for use with the investigational TruPulse generator, which offers each the RF power and the novel unipolar, biphasic pulse sequence to the catheter by the toggling of the 2 power sources on the generator monitor. This transmits the PF or RF power to the catheter tip electrode for cardiac ablation. The catheter and the generator are built-in with the Carto system.
Neither the Thermocool SmartTouch SF catheter nor the TruPulse generator is obtainable on the market in the USA. The research will enroll roughly 135 sufferers in Europe.
Final yr, Biosense Webster launched its Octaray Mapping Catheter with Trueref know-how powered by the Carto 3 Model 7 System. Based on MD+DI, the brand new cardiac mapping catheter was developed for the mapping of cardiac arrhythmias, together with atrial fibrillation (AFib).
