Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib.
AFib ablation has become a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year.
Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, performed the first procedures in the SmartPulse study of the system.
“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,” Natale said in a news release. “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.”
More about the Biosense Webster AFib treatment and trial
The company expects the SmartPulse prospective, single-arm, multi-center, clinical evaluation trial to enroll around 250 U.S. patients. It will evaluate the safety and effectiveness of the dual-energy STSF catheter.
Biosense Webster uses its investigational TruPulse generator to power the focal, contact force-sensing catheter. The catheter and generator, along with the Carto 3 mapping system, enable accurate 3D visualization. They also require minimal fluoroscopy for electrophysiologists and their staff.
The system also integrates parameters like contact force measurement and ablation indexes for RF and PFA. These prove critical for lesion creation.
Biosense Webster also has an ongoing SmartfIRE study evaluating the dual-energy catheter in Europe. That study looks at the treatment in patients with drug-refractory symptomatic paroxysmal AFib.
“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,” said Jasmina Brooks, president, 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.”