Boston Scientific ‘Positive’ Ablation Study

Boston Scientific says it has achieved “positive 12-month results” from its pivotal ADVENT clinical trial of the FaraPulse Pulsed Field Ablation (PFA) System, a nonthermal treatment using electric fields to selectively ablate heart tissue in patients with atrial fibrillation. The study directly compared the device to standard-of-care ablation (radiofrequency or cryoablation) for treating patients with paroxysmal or intermittent AF.

According to the company, data demonstrated that FaraPulse was noninferior to standard-of-care therapies, and met the primary efficacy and safety endpoints. Through 12 months, off-drug treatment success was 73.3% in the PFA arm compared to 71.3% in the thermal arm. “Results demonstrated superiority of the FaraPulse PFA System in the study’s secondary safety endpoint with significantly less post-ablation narrowing of the pulmonary veins at three months (0.9%) compared to the thermal ablation arm (12%),” it adds.