Biosense Webster Completes Enrollment in Pivotal Trial Evaluating PFA and RF Dual Energy Catheter for Patients with Atrial Fibrillation in Europe
Biosense Webster reported SmartfIRE is a pivotal, prospective, multi-center, single-arm study evaluating Biosense Webster’s dual energy pulsed field and radiofrequency ablation system. Since the study’s commencement in February 2023, the trial has enrolled 149 patients with paroxysmal AFib across nine centers in Europe. Patients will be assessed for 12 months for safety and efficacy.