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ADVENT Study of the FARAPULSE™ Pulsed Field Ablation System Meets Primary Efficacy and Safety Endpoints

Monday, August 28, 2023

Boston Scientific Corporation has revealed promising results from a year-long study called the ADVENT clinical trial involving the FARAPULSE™ Pulsed Field Ablation (PFA) System. This innovative system employs nonthermal methods using electric fields to precisely remove heart tissue in individuals with atrial fibrillation (AF). The study is groundbreaking, directly comparing the FARAPULSE PFA System's efficacy and safety with conventional ablation methods like radiofrequency or cryoablation, commonly used for addressing paroxysmal (intermittent) AF. The announcement occurred at the ESC Congress 2023, the annual meeting of the European Society of Cardiology, and was simultaneously published in The New England Journal of Medicine.

Key findings from the study include:

Demonstrated equivalence of the FARAPULSE PFA System compared to standard-of-care treatments, successfully meeting primary efficacy and safety goals.

Over 12 months, the success rate of a single procedure without medication was 73.3% for the PFA arm and 71.3% for the thermal arm, meeting the primary efficacy objective.

The primary composite safety endpoint, designed to assess acute and chronic device- and procedure-related serious adverse events within seven days post-procedure, resulted in a low adverse event rate of 2.1% in the PFA arm and 1.5% in the thermal arm.

In the study's secondary safety endpoint, the FARAPULSE PFA System outperformed the thermal ablation arm. Notably, there was significantly less post-ablation narrowing of the pulmonary veins at three months (0.9% compared to 12%).

The study highlighted the FARAPULSE PFA System's superiority in terms of ablation times. The PFA arm demonstrated notably shorter and less variable ablation times (average of 29.2 minutes with a standard deviation of 14.3 minutes) compared to the thermal arm (mean ablation time of 50.0 minutes with a standard deviation of 24.6 minutes).

Vivek Reddy, M.D., the study's lead investigator and an electrophysiologist at Mount Sinai Hospital, New York, praised the FARAPULSE PFA System's performance during the trial. He particularly emphasized the system's high rate of freedom from atrial arrhythmias and its commendably low rate of safety events.

The ADVENT trial involved 607 U.S. patients diagnosed with paroxysmal AF who had previously received unsuccessful treatment with at least one anti-arrhythmic drug.

Kenneth Stein, M.D., the senior vice president and global chief medical officer at Boston Scientific, commended the FARAPULSE PFA System's efficiency and safety outcomes. He expressed optimism about its potential utilization in the U.S. and mentioned the upcoming ADVANTAGE AF clinical trial. This forthcoming trial aims to investigate the system's efficacy in treating patients with persistent AF.

The FARAPULSE PFA System received CE Mark approval in 2021 and has been employed to treat over 25,000 patients globally thus far.


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