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Boston Scientific Corporation BSX released 12-month results from the pivotal ADVENT trial of the FARAPULSE Pulsed Field Ablation (PFA) System, a nonthermal treatment in which electric fields selectively ablate (remove body tissue surgically) heart tissue in patients with atrial fibrillation (AF). 

The 607-patient study compared the efficacy and safety of the FARAPULSE PFA System against standard-of-care ablation – either radiofrequency or cryoablation – for paroxysmal or intermittent AF in patients who had previously been unsuccessfully treated with at least one anti-arrhythmic drug.

The potential FDA approval of Farapulse might bolster Boston Scientific's position in the electrophysiology market, given that it could become the second PFA system available in the U.S.

Findings were presented at ESC Congress 2023, the European Society of Cardiology annual meeting, and simultaneously published in The New England Journal of Medicine.

Data demonstrated that the FARAPULSE PFA System was non+inferior to standard-of-care therapies, meeting the primary efficacy and safety endpoints, despite the vast majority of physicians having prior experience solely with thermal ablation.

Through 12 months, the single-procedure, off-drug treatment success was 73.3% in the PFA arm of the study and 71.3% in the thermal arm, which met the primary efficacy endpoint.

The primary composite safety endpoint – defined as acute and chronic device- and procedure-related serious adverse events within seven days of the procedure – was met with a comparably low adverse event rate of 2.1% (six events) in the PFA arm and 1.5% (four events) in the thermal arm.

Results demonstrated the 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%).

There were statistically shorter ablation times and less variability with the FARAPULSE PFA System within the PFA arm of the study (mean of 29.2 minutes with a standard deviation of 14.3 minutes) compared to the thermal arm (mean of 50.0 minutes with a standard deviation of 24.6 minutes).

In 2021, Europe approved the FARAPULSE PFA System.

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