Sam Brusco, Associate Editor12.15.23
Biosense Webster, a Johnson & Johnson MedTech company, revealed the first patient cases using its investigational Dual Energy ThermoCool SmartTouch SF (Dual Energy STSF) catheter took place, as part of its SmartPulse pivotal study to treat paroxysmal atrial fibrillation (AFib).
The SmartPulse study will enroll about 250 patients with paroxysmal AFib in the U.S. to evaluate its safety and effectiveness.
The Dual Energy STSF catheter is a focal, contact force sensing catheter that can deliver both radiofrequency (RF) and pulsed field ablation (PFA) energy. Its TruPulse generator provides RF and PFA by toggling the two energy sources on a generator monitor.
Both the catheter and generator are integrated with the company’s Carto 3 mapping system for 3D visualization with minimal fluoroscopy. The platform also integrates contact force measurement and ablation indexes for RF and PFA which can be used for lesion creation.
“The THERMOCOOL SMARTTOUCH SF Catheter is the most commonly used ablation catheter globally.iii 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,” said Jasmina Brooks, president of Biosense Webster. “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.”
In July 2023, Biosense Webster completed enrollment of the SmartfIRE study, which is evaluating safety and efficacy of the Dual Energy STSF catheter to treat of drug refractory symptomatic paroxysmal AFib in Europe.
Earlier this week, Medtronic received the first U.S. Food and Drug Administration (FDA) approval for pulsed field ablation (PFA) technology.
The SmartPulse study will enroll about 250 patients with paroxysmal AFib in the U.S. to evaluate its safety and effectiveness.
The Dual Energy STSF catheter is a focal, contact force sensing catheter that can deliver both radiofrequency (RF) and pulsed field ablation (PFA) energy. Its TruPulse generator provides RF and PFA by toggling the two energy sources on a generator monitor.
Both the catheter and generator are integrated with the company’s Carto 3 mapping system for 3D visualization with minimal fluoroscopy. The platform also integrates contact force measurement and ablation indexes for RF and PFA which can be used for lesion creation.
“The THERMOCOOL SMARTTOUCH SF Catheter is the most commonly used ablation catheter globally.iii 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,” said Jasmina Brooks, president of Biosense Webster. “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.”
In July 2023, Biosense Webster completed enrollment of the SmartfIRE study, which is evaluating safety and efficacy of the Dual Energy STSF catheter to treat of drug refractory symptomatic paroxysmal AFib in Europe.
Earlier this week, Medtronic received the first U.S. Food and Drug Administration (FDA) approval for pulsed field ablation (PFA) technology.