Strong clinical evidence base, largest volume of real-world use reinforce safety, efficacy and efficiency advantages of the systemMARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System.

强大的临床证据基础，最大的实际使用量增强了该系统的安全性，有效性和效率优势。马萨诸塞州马尔伯勒，2024年1月31日/PRNewswire/--波士顿科学公司（纽约证券交易所：BSX）宣布已获得美国食品和药物管理局（FDA）对法拉脉冲的批准™ 脉冲场消融（PFA）系统。

The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment..

FARAPULSE PFA系统适用于治疗药物难治性，复发性，症状性，阵发性（即间歇性）心房颤动（AF）的肺静脉隔离，是标准治疗热消融治疗的独特新替代方案。。

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The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.

FARAPULSE PFA系统适用于治疗药物难治性，复发性，症状性，阵发性（即间歇性）心房颤动（AF）的肺静脉隔离，是标准治疗热消融治疗的独特新替代方案。

'The approval of the FARAPULSE PFA System marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S.,' said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific.

波士顿科学公司（Boston Scientific）电生理学总裁尼克·斯帕迪亚·阿内洛（Nick Spadea Anello）说：“法拉脉冲PFA系统的批准对于数百万阵发性房颤患者来说是一个重要的里程碑，也是将第一个专为这种消融治疗而设计和制造的PFA系统带给美国医生的绝佳机会。”。

'A high bar has been set by performance of the system in clinical and commercial settings – where more than 40,000 patients have been treated to date – and we look forward to continuing to lead the way with this differentiated technology in the growing PFA space.'.

“该系统在临床和商业环境中的性能已经设定了一个很高的标准-迄今为止，已有40000多名患者接受了治疗-我们期待着在不断增长的PFA领域继续领先这种差异化技术。”。

During a traditional ablation procedure, a catheter is guided to the interior of the heart and generates extreme temperatures – hot or cold – to destroy targeted areas associated with abnormal heart rhythms. The FARAPULSE PFA System, however, relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures.

在传统的消融过程中，导管被引导到心脏内部，产生极端的温度-热或冷-以破坏与异常心律相关的目标区域。然而，法拉脉冲PFA系统依赖于组织选择性的非热电场来消融心脏组织并避免对周围结构的损伤。

Positive 12-month data from the pivotal ADVENT clinical trial – the first randomized clinical trial to directly compare the efficacy and safety of the system against standard-of-care ablation – found that therapy with the device was as safe and effective as conventional thermal ablation, with statistically shorter ablation times and a quick learning curve for physicians.

pivotal ADVENT临床试验（第一个直接比较系统与标准护理消融的疗效和安全性的随机临床试验）的12个月阳性数据发现，使用该设备的治疗与常规热消融一样安全有效，消融时间在统计学上更短，医生的学习曲线更快。

Additional real-world data from more than 17,000 patients in the MANIFEST-17K registry demonstrated continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury..

MANIFEST-17K登记处的17000多名患者的其他真实数据表明，该系统持续具有真实世界的安全性，没有永久性膈神经麻痹，肺静脉狭窄或食管损伤的报道。。

'Within the ADVENT clinical trial, the FARAPULSE PFA System was shown to be a safe, effective and efficient option for treating paroxysmal AF, and extensive global real-world use has mirrored that profile,' said Vivek Reddy, M.D., director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York.

纽约西奈山福斯特心脏医院电生理主任维韦克·雷迪（VivekReddy）医学博士说：“在ADRINCE临床试验中，法拉脉冲PFA系统被证明是治疗阵发性房颤的安全，有效和高效的选择，全球广泛的实际使用反映了这一情况。”。

'Tissue preferentiality and long-term efficacy, combined with markedly shorter procedure times and learning curves, position the FARAPULSE PFA System with strong potential to become a practice-changing technology for both U.S. physicians and patients alike.'The FARAPULSE PFA System delivers pulsed field energy and consists of the FARAWAVE™ Ablation Catheter, the FARASTAR™ Ablation Generator, and the FARADRIVE™ Steerable Sheath, which is complemented by the VersaCross Connect™ Access Solution for the FARADRIVE Steerable Sheath to provide safe and efficient access to the left side of the heart during procedures with the system.

“组织优先性和长期疗效，加上明显缩短的手术时间和学习曲线，使法拉脉冲PFA系统具有强大的潜力，成为美国医生和患者都可以改变实践的技术。”法拉脉冲PFA系统提供脉冲场能量，由远波组成™ 消融导管，FARASTAR™ 烧蚀发生器和法拉第™ 可操纵护套，由VersaCross Connect补充™ 法拉第导向护套的接入解决方案，可在系统操作过程中安全有效地接入心脏左侧。

The FARAWAVE catheter is used to treat a range of pulmonary vein anatomies using an over-the-wire catheter with variable basket and flower shapes, allowing the device to adapt to individual patient anatomies. These configurations reinforce ease-of-use for physicians and promote reproducible procedures between operators.Boston Scientific completed enrollment in the first phase of the ADVANTAGE AF clinical trial in the third quarter of 2023, which is studying the system for the treatment of patients with drug-refractory, symptomatic, persistent AF, and commenced enrollment in a second phase of the study to evaluate the safety and effectiveness of adjunctive use of the FARAPOINT™ PFA Catheter for cavotricuspid isthmus (CTI) ablations, a procedure used to treat atrial flutter.

FARAWAVE导管用于使用具有可变篮和花形状的线外导管治疗一系列肺静脉解剖结构，使该装置能够适应个体患者的解剖结构。这些配置增强了医生的易用性，并促进了操作者之间可重复的程序。波士顿科学公司于2023年第三季度完成了ADVANTAGE AF临床试验第一阶段的登记，该试验正在研究治疗药物难治性、症状性、持续性房颤患者的系统，并开始了第二阶段的登记，以评估辅助使用法拉波点的安全性和有效性™ 用于消融腔三尖瓣峡部（CTI）的PFA导管，这是一种用于治疗心房扑动的程序。

The company also recently commenced the AVANT GUARD clinical trial to evalu.

该公司最近还开始了evalu的AVANT GUARD临床试验。