Boston Scientific Announces Positive 12-Month Results from Pivotal ADVENT Trial of FARAPULSE™ Pulsed Field Ablation System for Paroxysmal Atrial Fibrillation

Study results published simultaneously at the 2023 ESC Congress and in The New England Journal of Medicine

Marlborough, Massachusetts, USAAugust 28, 2023PR Newswire -- Boston Scientific Corporation (NYSE: BSX)RecentlyJapan Announces FARAPULSE™ Pulsed Field Ablation（PFA）Positive 12-Month Results from the Pivotal ADVENT Clinical Trial for the FARAPULSE™ Pulsed Field Ablation System（PFA）The system adopts a non-thermal therapy, selectively ablating atrial fibrillation through an electric field.（AF）The patient's cardiac tissue. This study is Boston Scientific's first direct comparison of the FARAPULSE PFA system with standard ablation.（Radiofrequency or Cryoablation）A randomized controlled study on the efficacy and safety for the treatment of paroxysmal atrial fibrillation. The results were presented at the European Society of Cardiology Congress 2023 (ESC Congress 2023) and simultaneously published in The New England Journal of Medicine.

Study data show that despite the vast majority of physicians having only thermal ablation experience, the FARAPULSE PFA System results were non-inferior to standard ablation, achieving both its primary effectiveness endpoint and primary safety endpoint.

"The principal investigator of this study, Dr. Vivek Reddy, an electrophysiologist at Mount Sinai Hospital in New York, stated: 'In this study, the overall clinical performance of the FARAPULSE PFA system was excellent, particularly with a high rate of freedom from atrial arrhythmia recurrence and an extremely low rate of safety events. Considering the rigor of the study design and monitoring protocols, these results are remarkable. Combined with the extensive data previously gathered in Europe, these highly anticipated outcomes further solidify the position of PFA therapy as the preferred choice for ablation treatment.'"

This multicenter, prospective, randomized controlled study enrolled 607 patients with paroxysmal atrial fibrillation in the United States who had previously failed at least one antiarrhythmic drug treatment.

Dr. Kenneth Stein, Senior Vice President and Global Chief Medical Officer of Boston Scientific Corporation, stated："These data highlight the superior surgical efficiency of this new technology, and it is expected to continue yielding robust safety and efficacy outcomes in real-world applications. The findings are an encouraging sign for the potential use of the FARAPULSE PFA System in the United States, and we look forward to the ADVANTAGE AF clinical trial, which began recruiting earlier this year, to further explore the system's feasibility for treating patients with persistent atrial fibrillation."

The FARAPULSE PFA System received CE certification in 2021 and has been used globally to treat more than 25,000 patients to date.

*This product has not yet been approved in mainland China.

About Boston Scientific Corporation

Boston Scientific Corporation is committed to innovation for life. We are dedicated to innovative medical solutions that improve the lives of patients around the world. For more than four decades, Boston Scientific has consistently led the development of the global medical technology industry by providing a wide range of high-performance medical solutions. These solutions address critical treatment needs for a broad patient population while reducing healthcare costs.

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