Boston Scientific Announces Farapulse PFA Data
Boston Scientific announced data supporting use of the company's Farapulse Pulsed Field Ablation, PFA, Platform and Watchman Left Atrial Appendage Closure, LAAC, technologies. All data were presented at Heart Rhythm 2026, the annual meeting of the Heart Rhythm Society, held in Chicago from April 24-26. Results from the Avant Guard clinical trial of Farapulse PFA: PFA achieved superiority over AADs with a primary effectiveness rate of 56.0% at 12 months compared to 30.1% in the AAD group. The primary safety endpoint was met with major adverse event rate of 5.1% at 12 months. Significantly more patients in the PFA group were free from atrial arrhythmia recurrence at 12 months, compared to 32.2% in the AAD group. Results from the feasibility study of the Faraplex PFA Catheter: With workflow improvements, PVI durability - the permanence of an ablation lesion over time - increased from 80.4% on a per-vein basis in the feasibility group to 96.4% in the optimized group. Within the optimized group, PVI durability in patients with persistent AF was 95.6% at two months. Clinical outcomes associated with real-world concomitant PFA and LAAC interventions: Ablation with the FARAWAVE PFA Catheter achieved a 100% acute success rate. Ablation parameters such as lesion sets and procedure duration were consistent with those observed in standalone PFA procedures. LAAC with the WATCHMAN FLX Pro implant also achieved 100% procedural success and 90.6% complete LAA closure at a mean of 66 days with no clinically relevant leaks or device-related thrombus reported.
