First phase of ADVANTAGE AF clinical trial achieves safety and effectiveness endpoints for treatment of drug-resistant, symptomatic, persistent atrial fibrillation with the FARAPULSE™ Pulsed Field Ablation System

ADVANTAGE AF临床试验的第一阶段通过FARAPULSE™脉冲场消融系统实现了治疗耐药性，症状性，持续性房颤的安全性和有效性终点

Sub-analysis from OPTION clinical trial highlights consistent safety and efficacy outcomes with the WATCHMAN FLX™ Left Atrial Appendage Closure Device post cardiac ablation in both concomitant and sequential procedures

OPTION临床试验的子分析强调了WATCHMAN FLX™左心耳闭合装置在心脏消融后同时和顺序手术中的一致安全性和有效性结果

MARLBOROUGH, Mass.

马萨诸塞州马尔伯勒。

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,

Jan. 16, 2025

2025年1月16日

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/

PRNewswire

PRNewswire 的

/ -- Boston Scientific Corporation (NYSE: BSX) today announced data supporting the use of the FARAPULSE

/--波士顿科学公司（纽约证券交易所：BSX）今天宣布了支持使用法拉脉冲的数据

™

™

Pulsed Field Ablation (PFA) System* and the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device, respectively, during a late-breaking science session at AF Symposium 2025.

。

ADVANTAGE AF clinical study

ADVANTAGE AF临床研究

Currently, the FARAPULSE PFA System is approved for pulmonary vein isolation (PVI) in patients who have paroxysmal AF, an irregular heartbeat that occurs occasionally and typically spontaneously resolves back to normal rhythm. The ADVANTAGE AF study examined use of the FARAPULSE PFA System for both PVI and posterior wall ablation (PWA) in patients who have persistent AF, where individuals experience an irregular or rapid heartbeat that lasts longer than seven days and which represent 25% of all AF cases..

目前，FARAPULSE PFA系统被批准用于阵发性房颤患者的肺静脉隔离（PVI），阵发性房颤是偶尔发生的不规则心跳，通常会自发恢复正常节律。ADVANTAGE AF研究检查了在持续性房颤患者中使用FARAPULSE PFA系统进行PVI和后壁消融（PWA）的情况，这些患者的心跳不规则或快速，持续时间超过7天，占所有房颤病例的25%。。

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The prospective, single arm trial included 260 patients enrolled at 43 global sites who were drug intolerant to at least one Class I/III anti-arrhythmic drug (AAD).

这项前瞻性单臂试验包括在全球43个地点登记的260名患者，这些患者对至少一种I/III类抗心律失常药物（AAD）不耐受。

Key findings from the study through 12 months included:

这项为期12个月的研究的主要发现包括：

The primary safety endpoint – defined as serious adverse events related to either the use of an ablation catheter or the ablation procedure within seven days of the primary procedure and pulmonary vein stenosis or atrio-esophageal fistula out to 12 months – was met with a 2.3% event rate.

主要安全终点-定义为在主要手术后7天内使用消融导管或消融手术以及肺静脉狭窄或心房食管瘘持续12个月的严重不良事件-事件发生率为2.3%。

The primary effectiveness endpoint – defined as freedom from AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion and use of a new or escalated dose of Class I/III AAD or amiodarone – was met at 63.5%.

主要有效性终点-定义为无房颤，心房扑动，房性心动过速，再次消融，复律和使用新剂量或递增剂量的I/III类AAD或胺碘酮-达到63.5%。

The symptomatic AF recurrence-free rate was 85.3% and observationally, among physicians that performed three or more procedures, the symptomatic recurrence-free rate increased to 91.8%.

症状性房颤无复发率为85.3%，观察到，在进行三次或三次以上手术的医生中，症状性无复发率增加到91.8%。

There were no reported incidences of stroke, pulmonary vein stenosis, atrio-esophageal fistula or major access complications.

没有报道中风，肺静脉狭窄，心房食管瘘或主要通路并发症的发生率。

'In addition to the positive safety and efficacy outcomes achieved in the ADVANTAGE AF study, a significant number of patients were able to discontinue AADs as well as see greater improvements in quality of daily life,' said

“除了在ADVANTAGE AF研究中取得的积极的安全性和有效性结果外，大量患者能够停用AAD，并看到日常生活质量的更大改善，”他说

Vivek Reddy

维维克 雷迪

, M.D.**, director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York and study principal investigator. 'As the population of patients living with AF continues to grow, data from trials such as ADVANTAGE AF further support the paradigm shift to PFA as a treatment for patients who are living with persistent and other complex forms of AF.'.

，医学博士*，纽约西奈山福斯特心脏医院电生理学主任，研究首席研究员。”随着房颤患者人数的不断增加，ADVANTAGE AF等试验的数据进一步支持了PFA作为持续性和其他复杂形式房颤患者治疗的范式转变。

OPTION trial sub-analysis

期权试用子分析

The late-breaking session also included a prespecified sub-analysis from the OPTION clinical trial that built upon the positive primary endpoint results presented at the American Heart Association 2024 meeting and published in

最新的会议还包括OPTION临床试验的预先指定的子分析，该分析建立在美国心脏协会2024年会议上提出的积极主要终点结果的基础上，并发表在

The New England Journal of Medicine

新英格兰医学杂志

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.

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In line with the overall 36-month outcomes from this first head-to-head study of the WATCHMAN FLX device and direct oral anticoagulants (95% DOAC, 5% warfarin), the sub-analysis of 1,600 patients with atrial fibrillation who underwent a device implantation either concomitantly or sequentially (90-180 days post ablation) demonstrated:.

根据WATCHMAN FLX装置和直接口服抗凝剂（95%DOAC，5%华法林）的首次头对头研究的总体36个月结果，对1600名同时或顺序（消融后90-180天）接受装置植入的房颤患者进行了亚分析。

Consistent with the previously presented primary safety and efficacy endpoint data presented in

与先前提供的主要安全性和有效性终点数据一致

November 2024

2024年11月

, concomitant LAAC with the WATCHMAN FLX device following an ablation demonstrated a statistically significant 44% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8.0% vs. 13.3%; p=0.02) and similar efficacy outcomes (7.0% vs. 6.7% p=0.91), with the primary efficacy endpoint defined as all-cause death, stroke or systemic embolism..

，消融后伴随LAAC和WATCHMAN FLX装置显示，与36个月时的OAC（8.0%比13.3%；p=0.02）和类似的疗效结果（7.0%比6.7%p=0.91）相比，非手术性出血结果减少了44%，主要疗效终点定义为全因死亡，中风或全身性栓塞。。

Also consistent with the previously presented primary safety and efficacy endpoint data, sequential LAAC with the WATCHMAN FLX device following an ablation demonstrated a statistically significant 62% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8.8% vs. 21.5%; p<0.0001) and similar efficacy outcomes (4.2% vs.

同样与之前提出的主要安全性和有效性终点数据一致，消融后使用WATCHMAN FLX装置的序贯LAAC在36个月时与OAC相比，非手术性出血结果减少了62%（8.8%比21.5%；p<0.0001）和类似的疗效结果（4.2%比4.2%）。

5.3%; p=0.45)..

5.3%；p=0.45）。。

Similar stroke protection with the WATCHMAN FLX device compared to OAC irrespective of concomitant (2.3% vs. 2.5% rates of all stroke) or sequential (1.1% vs 1.6%) implantation.

与OAC相比，WATCHMAN FLX装置具有类似的中风保护作用，无论伴随（2.3%比2.5%的所有中风发生率）还是顺序（1.1%比1.6%）植入。

'These late-breaking studies provide valuable clinical evidence supporting our ablation and stroke prevention technologies that are designed to improve long-term outcomes for patients with atrial fibrillation,' said Dr.

。

Brad Sutton

布拉德 萨顿

, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific. 'The positive findings support our focus on expanding the number of patients who can benefit from these life-changing therapies, which we will continue to advance through future clinical trials and product development.'.

，医学博士，波士顿科学公司心房颤动解决方案首席医疗官。”这些积极的发现支持了我们对扩大可以从这些改变生命的疗法中受益的患者数量的关注，我们将通过未来的临床试验和产品开发继续推进这些疗法。”。

More information on the ADVANTAGE AF study is available

有关ADVANTAGE AF研究的更多信息

here

在这里

and on the OPTION trial

以及期权审判

here

在这里

.***

.***

About Boston Scientific

关于波士顿科学

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.

Boston Scientific通过创新的医疗技术改变生活，改善世界各地患者的健康。作为全球医疗技术领导者已有45多年的历史，我们通过提供广泛的高性能解决方案来解决未满足的患者需求并降低医疗保健成本，从而推动生命科学的发展。

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 .

我们的设备和疗法组合可帮助医生诊断和治疗复杂的心血管、呼吸、消化、肿瘤、神经和泌尿系统疾病和病症。更多信息，请访问。

www.bostonscientific.com

www.bostonscientific.com

and connect on

并连接到

LinkedIn

LinkedIn

and

和

X

十

, formerly Twitter.

，以前是Twitter。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like 'anticipate,' 'expect,' 'project,' 'believe,' 'plan,' 'estimate,' 'intend' and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our business plans and product performance and impact, clinical trials, and new and anticipated product approvals and launches.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements..

本新闻稿包含1933年《证券法》第27A节和1934年《证券交易法》第21E节所指的前瞻性声明。前瞻性声明可以用“预期”、“预期”、“项目”、“相信”、“计划”、“估计”、“打算”等词和类似词来识别。这些前瞻性陈述是基于我们的信念、假设和估计，并使用我们当时可用的信息，并不旨在保证未来的事件或表现。这些前瞻性声明包括有关我们的业务计划、产品性能和影响、临床试验以及新的和预期的产品批准和发布的声明。如果我们的基本假设不正确，或者出现某些风险或不确定性，实际结果可能与我们的前瞻性陈述所表达或暗示的预期和预测有很大差异。在某些情况下，这些因素已经产生影响，并且在未来（连同其他因素）可能会影响我们实施业务战略的能力，并可能导致实际结果与本新闻稿中所述的预期结果产生重大差异。因此，提醒读者不要过度依赖我们的任何前瞻性陈述。。

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law.  This cautionary statement is applicable to all forward-looking statements contained in this document..

可能导致这种差异的因素包括：未来的经济、竞争、报销和监管条件；地缘政治事件；制造、分销和供应链中断以及成本增加；网络安全事件造成的中断；公共卫生突发事件或极端天气或其他气候变化相关事件造成的中断；劳动力短缺和劳动力成本增加；正在进行和未来的临床试验和市场研究结果的变化；新产品介绍；；收购的结束和整合；人口趋势；知识产权；诉讼；金融市场状况；以及我们和竞争对手做出的未来业务决策。所有这些因素都很难或不可能准确预测，其中许多因素超出了我们的控制范围。有关这些和其他可能影响我们未来运营的重要风险和不确定性的进一步列表和描述，请参阅我们向证券交易委员会提交的最新10-K表年度报告中的第一部分第1A项-风险因素，我们可能会在第二部分第1A项-我们已经提交或将在以后提交的10-Q表季度报告中的风险因素中进行更新。我们不打算或有义务公开更新或修订任何前瞻性声明，以反映我们的期望或这些期望可能基于的事件、条件或情况的任何变化，或者可能影响实际结果与前瞻性声明中所载结果不同的可能性，除非法律要求。本警示声明适用于本文件中包含的所有前瞻性声明。。

CONTACTS:

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贝卡 约翰逊

Media Relations

媒体关系

+1 (952) 994-8526

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*CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Ablation beyond pulmonary vein isolation is outside the use of labeled indication of the FARAWAVE PFA Catheter with the FARAPULSE PFA System.

*。受联邦（或美国）法律限制，仅用于研究用途。肺静脉隔离以外的消融不在使用FARAPULSE PFA系统的FARAWAVE PFA导管的标记指示范围内。

**Dr. Vivek Reddy is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.

**维韦克·雷迪博士是波士顿科学公司的有偿顾问。他没有得到与本新闻稿有关的赔偿。

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The FARAPULSE PFA System was not commercially available at the time of the OPTION trial initiation and was not included in the trial design.

在OPTION试验开始时，FARAPULSE PFA系统尚未商业化，并且未包括在试验设计中。

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Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective.

Zoni Berisso M，Lercari F，Carazza T，Domenicucci S.心房颤动的流行病学：欧洲观点。

Clin Epidemiol

临床流行病学

. 2014;6:213-220. doi: 10.2147/CLEP.S47385

. 2014;6:213-220.二：10.2147/CLEP。S47385

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Wazni OM, Saliba WI, Nair DG, et al. Left atrial appendage closure after ablation for atrial fibrillation.

Wazni OM，Saliba WI，Nair DG等。心房颤动消融后左心耳闭合。

N Engl J Med

恩格尔 J Med

. 2024 Nov 16. doi:10.1056/NEJMoa2408308

2024年11月16日。doi:10.1056/NEJMoa2408308

SOURCE Boston Scientific Corporation

来源波士顿科学公司