/ -- Boston Scientific Corporation (NYSE: BSX) today announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the FARAPULSE™ Pulsed Field Ablation (PFA) System* and adjunctive use of the FARAPOINT™ PFA Catheter in patients with persistent atrial fibrillation (AF).

波士顿科学公司（纽约证券交易所代码：BSX）今天宣布了ADVANTAGE AF临床试验第二阶段的12个月主要终点结果，该试验评估了FARAPULSE™脉冲场消融（PFA）系统*及辅助使用FARAPOINT™ PFA导管在持续性心房颤动（AF）患者中的应用。

Key findings from the study were presented at the second annual PFA Live Case Summit in .

这项研究的主要发现呈现在第二届PFA Live年度案例峰会中。

and simultaneously published in Circulation

同时发布在Circulation

Persistent AF, which accounts for approximately 25%

持续性房颤，约占25%

of all AF cases, is an abnormal, rapid heartbeat that lasts for at least seven days in a row and can lead to complications such as blood clots, stroke and heart failure. The second phase of the ADVANTAGE AF trial studied the FARAWAVE™ PFA Catheter for both pulmonary vein isolation (PVI) and posterior wall ablation (PWA) and the FARAPOINT PFA Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter (AFL), a type of heart rhythm disorder.

在所有房颤病例中，这是一种异常的、持续至少连续七天的快速心跳，可能导致血栓、中风和心力衰竭等并发症。ADVANTAGE AF试验的第二阶段研究了FARAWAVE™ PFA导管用于肺静脉隔离（PVI）和后壁消融（PWA），以及FARAPOINT PFA导管用于腔静脉三尖瓣峡部（CTI）消融，以治疗典型的心房扑动（AFL），这是一种心律失常疾病。

All patients in the trial were continuously monitored after their procedure with the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, which is designed to detect recurrence of cardiac arrhythmias and assess AF burden. Findings from the trial met all pre-specified safety and effectiveness endpoints and demonstrated:.

试验中的所有患者在手术后均通过LUX-Dx™植入式心脏监测仪（ICM）系统进行了持续监测，该系统旨在检测心律失常的复发并评估房颤负担。试验结果达到了所有预先设定的安全性和有效性终点，并证明了：

73.4% freedom from AF, AFL and atrial tachycardia (AT), which exceeded the performance goal of 40% or higher.

73.4% 的患者无房颤（AF）、房扑（AFL）和房性心动过速（AT），超过了 40% 或更高的性能目标。

A safety event rate of 2.4% and no reports of pulmonary vein stenosis, atrio-esophageal fistula or phrenic nerve palsy which met the performance goal of 12% or lower.

安全事件发生率为2.4%，无肺静脉狭窄、心房食管瘘或膈神经麻痹的报告，达到了12%或更低的性能目标。

81.0% freedom from symptomatic documented AF recurrence, which is defined as arrhythmia, clinical intervention or use of escalated or new Class I/III anti-arrhythmic drugs.

81.0% 的患者无症状性房颤复发，定义为心律失常、临床干预或使用升级的或新的 I 类/III 类抗心律失常药物。

71.6% of patients had virtually no atrial arrhythmia (AA) burden, in which data shows lower AA burden can be associated with fewer clinical interventions and improvements in quality of life and 52% of patients had no residual AA events after the blanking period.

71.6% 的患者几乎没有任何心房心律失常 (AA) 负担，数据表明较低的 AA 负担可能与较少的临床干预和生活质量改善相关，52% 的患者在空白期后没有残留的 AA 事件。

96.4% of patients treated with the FARAPOINT PFA Catheter had no recurrence of AFL.

96.4% 的使用 FARAPOINT PFA 导管治疗的患者房扑未复发。

'Continuous rhythm monitoring in phase two of the ADVANTAGE AF study allowed for a detailed picture of patients' cardiac rhythm after ablation, including asymptomatic AF recurrence, which is not often captured in U.S. Food and Drug Administration clinical trial monitoring but is important for the ability to provide more individualized care to patients,' said Vivek Reddy, M.D.**, director, Cardiac Arrhythmia Services, Mount Sinai Health System and Leona M.

“在ADVANTAGE AF研究的第二阶段，持续的节律监测使得我们能够详细了解患者在消融术后的 cardiac rhythm（心脏节律），包括无症状的房颤复发。这种情况在美国食品药品监督管理局的临床试验监测中通常难以捕捉到，但对于提供更个性化的患者护理非常重要，” Mount Sinai Health System心脏节律服务主任兼Leona M. 的Vivek Reddy博士表示。

and Harry B. Helmsley Charitable Trust professor of medicine, Cardiac Electrophysiology, Icahn School of Medicine and study principal investigator. 'The data collected in this trial continues to support the FARAPULSE PFA System as a safe and effective therapy, now with evidence highlighting positive results for its use in treating patients who suffer from persistent AF.'.

和哈里·B·赫尔姆斯利慈善信托基金医学教授，心脏电生理学，伊坎医学院及研究主要负责人。“这项试验中收集的数据继续支持FARAPULSE PFA系统作为一种安全有效的治疗方法，现在有证据突显了其在治疗持续性房颤患者中的积极结果。”

This prospective, single arm trial included 255 patients enrolled at 29 U.S. sites who were treated with the FARAWAVE PFA Catheter, and of those, 141 patients also received CTI ablation with the FARAPOINT PFA Catheter for AFL. The FARAPOINT PFA Catheter is a navigation-enabled point catheter that uses a smaller ablation footprint to create focal and linear-shaped lesions and integrates with the Boston Scientific OPAL HDx™ Mapping System to provide visualization of catheter placement during procedures..

这项前瞻性、单臂试验包括在美国29个地点注册的255名患者，他们接受了FARAWAVE PFA导管治疗，其中141名患者还使用FARAPOINT PFA导管进行了CTI消融以治疗AFL。FARAPOINT PFA导管是一种具备导航功能的点状导管，采用较小的消融覆盖范围来创建焦点和线性病变，并与波士顿科学公司的OPAL HDx™映射系统集成，以便在手术过程中提供导管放置的可视化。

'These positive study results are an important step forward in the continued innovation of the proven FARAPULSE PFA System and our broader portfolio of products that treat AF,' said

“这些积极的研究结果是经过验证的FARAPULSE PFA系统以及我们治疗房颤的更广泛产品组合持续创新的重要一步，”

Brad Sutton

布拉德·萨顿

, M.D., chief medical officer, AF Solutions, Boston Scientific. 'The performance of the devices in this trial – the FARAPOINT and FARAWAVE PFA Catheters as well as the LUX-Dx ICM System – is an encouraging sign as we work towards expanding our portfolio to provide physicians with an even more robust toolset to treat the growing number of patients with AF.'.

，医学博士，波士顿科学AF解决方案首席医疗官。“在这次试验中，这些设备的表现——FARAPOINT和FARAWAVE PFA导管以及LUX-Dx ICM系统——是一个令人鼓舞的信号，因为我们正在努力扩展我们的产品组合，为医生提供更强大的工具集，以治疗越来越多的心房颤动患者。”

Boston Scientific anticipates U.S. Food and Drug Administration approval to expand the instructions for use labeling for the FARAPULSE PFA System to include persistent AF as well as European and U.S. regulatory approvals for the FARAPOINT PFA Catheter in the second half of 2025.

波士顿科学公司预计，美国食品药品监督管理局将批准扩展FARAPULSE PFA系统的使用说明标签，以包括持续性房颤，并预计在2025年下半年获得FARAPOINT PFA导管的欧洲和美国监管批准。

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.

波士顿科学通过创新的医疗技术改变生活，这些技术改善了全球患者的健康状况。作为拥有45年以上历史的全球医疗技术领导者，我们通过提供广泛的一系列高性能解决方案推动生命科学发展，满足患者未被满足的需求，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 .

我们的设备和疗法产品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 。