Sam Brusco, Associate Editor04.09.24
Biosense Webster (a Johnson & Johnson MedTech company) revealed three-month follow-up results from its SmartfIRE trial in the annual meeting of the European Heart Rhythm Association (EHRA).
The trial enrolled 149 adult patients in Europe with drug refractory paroxysmal AFib, identified as candidates for catheter ablation.
Findings demonstrated that use of the Dual Energy Thermocool Smarttouch SF catheter during electrophysiology mapping and ablation procedures for drug refractory symptomatic paroxysmal AFib patients led to a 100% acute procedural success, with 96.8% no acute reconnections shown in the veins.
According to Biosense Webster, Thermocool Smarttouch SF is the first dual energy, pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index.
The ablation system consists of the Thermocool Smarttouch SF irrigated, contact-force sensing catheter and the Trupulse generator, which offers both RF and PF energy to the catheter via toggling of the two energy sources on the generator monitor. Both are integrated with the company’s Carto 3 system for live 3D mapping and advanced visualization during ablation.
The SmartfIRE trial also showed that when used for isolation of the atrial pulmonary veins (PVs) to treat patients with paroxysmal AFib (N=137), catheter ablation using PF and RF enabled a total energy application time of median 12.8 min and fluoroscopy exposure of 4.2 minutes.
“The initial results from the SmartfIRE trial suggest that the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter, together with the TRUPULSE Generator and the CARTO 3 System, is a promising advancement in cardiac ablation,” said Jennifer Currin, Ph.D., VP, Scientific Affairs, Cardiovascular & Specialty Solutions Group at Johnson & Johnson MedTech. “As Biosense Webster works to develop a versatile portfolio of PFA solutions, we believe that the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter will be a valuable addition to the set of tools electrophysiologists use to address diverse ablation strategies in the treatment of atrial arrhythmias.”
SmartfIRE started in February 2023, with patients in Austria, Belgium, Denmark, and Lithuania, and is due to finish at the end of 2024.
The trial enrolled 149 adult patients in Europe with drug refractory paroxysmal AFib, identified as candidates for catheter ablation.
Findings demonstrated that use of the Dual Energy Thermocool Smarttouch SF catheter during electrophysiology mapping and ablation procedures for drug refractory symptomatic paroxysmal AFib patients led to a 100% acute procedural success, with 96.8% no acute reconnections shown in the veins.
According to Biosense Webster, Thermocool Smarttouch SF is the first dual energy, pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index.
The ablation system consists of the Thermocool Smarttouch SF irrigated, contact-force sensing catheter and the Trupulse generator, which offers both RF and PF energy to the catheter via toggling of the two energy sources on the generator monitor. Both are integrated with the company’s Carto 3 system for live 3D mapping and advanced visualization during ablation.
The SmartfIRE trial also showed that when used for isolation of the atrial pulmonary veins (PVs) to treat patients with paroxysmal AFib (N=137), catheter ablation using PF and RF enabled a total energy application time of median 12.8 min and fluoroscopy exposure of 4.2 minutes.
“The initial results from the SmartfIRE trial suggest that the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter, together with the TRUPULSE Generator and the CARTO 3 System, is a promising advancement in cardiac ablation,” said Jennifer Currin, Ph.D., VP, Scientific Affairs, Cardiovascular & Specialty Solutions Group at Johnson & Johnson MedTech. “As Biosense Webster works to develop a versatile portfolio of PFA solutions, we believe that the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter will be a valuable addition to the set of tools electrophysiologists use to address diverse ablation strategies in the treatment of atrial arrhythmias.”
SmartfIRE started in February 2023, with patients in Austria, Belgium, Denmark, and Lithuania, and is due to finish at the end of 2024.