/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The updated labeling now includes approval for the system in the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF), an arrythmia in which the heart beats abnormally for at least seven days..

/ -- 波士顿科学公司（纽约证券交易所代码：BSX）已获得美国食品和药物管理局（FDA）批准，扩大FARAPULSE™脉冲场消融（PFA）系统的使用说明（IFU）标签。更新后的标签现在包括该系统在治疗药物难治性、有症状的持续性心房颤动（AF）中的应用，这是一种心脏异常跳动至少持续七天的心律失常。

AF affects an estimated 59 million people worldwide and many have the persistent form of the condition, which can cause dizziness, fatigue, shortness of breath and increase the risk of stroke. The FARAPULSE PFA System treats AF by delivering pulsed field energy through a catheter to ablate heart tissue.

心房颤动影响全球约 5900 万人，其中许多人为持续性心房颤动，这种疾病可能导致头晕、疲劳、呼吸急促并增加中风风险。FARAPULSE PFA 系统通过导管传递脉冲场能量消融心脏组织来治疗心房颤动。

This approval updates the IFU for both the FARAWAVE™ PFA Catheter and the FARAWAVE NAV™ PFA Catheter to include treatment for patients with persistent AF..

该批准更新了FARAWAVE™ PFA导管和FARAWAVE NAV™ PFA导管的使用说明书，以包括对持续性房颤患者的治疗。

'Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AF treatment with safe and effective ablation technologies,' said

“凭借临床证据和我们的全球商业经验，此次更新推动了我们通过安全有效的消融技术进一步塑造房颤治疗未来的工作，”表示

Brad Sutton

布拉德·萨顿

, M.D., chief medical officer, AF Solutions, Boston Scientific. 'We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.'.

，医学博士，波士顿科学AF Solutions首席医疗官。“我们期待在新的临床试验中研究该系统，包括需要再次消融的患者和那些患有更复杂心律失常的患者，这些患者占了当今仍然使用热消融手术的很大一部分。”

The FDA approval for expanded labeling was supported by clinical evidence from phase one of the ADVANTAGE AF clinical trial presented at AF Symposium 2025 and recently published in the

FDA批准扩大标签的决定是基于在2025年心房颤动研讨会上展示的ADVANTAGE AF临床试验第一阶段的临床证据，该证据最近也已发表在

Journal of the American College of Cardiology

美国心脏病学会杂志

and met both the primary safety and effectiveness endpoints. In the prospective, single-arm trial, 260 patients who were drug intolerant to at least one Class I/III anti-arrhythmic drug (AAD) were enrolled at 43 global sites. There were no reported incidences of stroke, pulmonary vein stenosis, atrio-esophageal fistula or major access complications and the symptomatic AF recurrence-free rate was 85.3%.

并且达到了主要的安全性和有效性终点。在这项前瞻性、单臂试验中，共有260名对至少一种I/III类抗心律失常药物（AAD）不耐受的患者在全球43个地点入组。试验中未报告中风、肺静脉狭窄、心房食管瘘或主要通路并发症的病例，且无症状的房颤复发率为85.3%。

Observationally, among physicians that performed three or more procedures, the symptomatic recurrence-free rate increased to 91.4%..

观察性地，在进行过三次或以上手术的医生中，无症状复发率提高到了91.4%。

Boston Scientific anticipates CE mark as well as approval in

波士顿科学公司预计会获得CE标志以及批准在

Japan

日本

and

和

China

中国

in the coming months. The company also recently initiated the ReMATCH IDE clinical trial, which will study approximately 375 patients across 40 centers in the U.S. and

在未来几个月内。该公司最近还启动了ReMATCH IDE临床试验，该试验将在美国的40个中心研究大约375名患者，并且

Asia

亚洲

. The study will evaluate the safety and effectiveness of the FARAWAVE PFA Catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AF who previously received an ablation with a PFA, radiofrequency or cryoablation catheter and experienced a recurrence of the condition.

该研究将评估FARAWAVE PFA导管在持续性房颤患者中进行后壁消融和肺静脉隔离的安全性和有效性，这些患者之前曾接受过PFA、射频或冷冻消融导管治疗并出现病情复发。

It will also evaluate adjunctive use of the FARAPOINT™ PFA Catheter* for cavotricuspid isthmus ablation and left atrial ablation of the mitral isthmus in the same patient population..

它还将在同一患者群体中评估FARAPOINT™ PFA导管*在腔静脉三尖瓣峡部消融和二尖瓣峡部左心房消融中的辅助应用。

About Boston Scientific

关于波士顿科学公司

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care.

波士顿科学通过创新的医疗技术改善全球患者的健康，从而改变生活。作为拥有45年以上历史的全球医疗技术领导者，我们通过提供广泛高性能的解决方案推动生命科学发展，满足未被满足的患者需求并降低医疗成本。

Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at .

我们的设备和治疗方案组合帮助医生诊断和治疗复杂的心血管、呼吸系统、消化系统、肿瘤学、神经学和泌尿系统疾病及病症。欲了解更多信息，请访问。