ADVENT Study of FARAPULSE? Pulsed Field Ablation System Meets Key Efficacy and Safety Criteria

波科 (NYSE: BSX) today announced positive 12-month results from the pivotal ADVENT clinical trial of the FARAPULSE?* Pulsed Field Ablation (PFA) System, a non-thermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation. (A F). The study is the first randomized clinical trial directly comparing the efficacy and safety of the FARAPULSE PFA System to standard ablation – either radiofrequency or cryoablation – for the treatment of patients with paroxysmal or intermittent AF. The findings were presented at ESC 2023, the annual meeting of the European Society of Cardiology, and simultaneously published in the New England Journal of Medicine.

The data demonstrated that the FARAPULSE PFA System was not inferior to standard therapies, meeting key efficacy and safety endpoints, even though the vast majority of physicians had prior experience only with thermal ablation.

Over 12 months, the success of non-drug therapy in a single procedure 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 serious acute and chronic device- and procedure-related adverse events within seven days of the procedure – was met with a comparatively low adverse event rate of 2.1% (six events) in the PFA arm and 1.5% (four events) in the heat arm.

The results demonstrated the superiority of the FARAPULSE PFA System on the secondary safety endpoint of the study, with significantly less post-ablation narrowing of the pulmonary veins at three months (0.9%) compared to the arm of thermal ablation (12%).

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

Excellent overall clinical performance of the FARAPULSE PFA System was observed in this study, particularly the high rate of freedom from atrial arrhythmias and the very low rate of safety events, which is impressive given the stringency of the design of the trial and the monitoring protocols used," said Vivek Reddy, M.D., the study's principal investigator and electrophysiologist at Mount Sinai Hospital in New York. "These highly anticipated results, along with extensive data earlier studies from Europe consolidate PFA therapy with this system as the preferred ablative treatment modality.

In this multicenter, prospective, randomized controlled trial, 607 patients in the United States with paroxysmal AF who had been unsuccessfully treated with at least one antiarrhythmic drug were recruited.

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