Biosense Webster Inc., a leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the Varipulse Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib) using pulsed field ablation (PFA)..

Biosense Webster Inc.是心律失常治疗的领导者，也是强生医疗技术的一部分，已获得日本厚生劳动省（MHLW）的批准，用于使用脉冲场消融（PFA）治疗症状性药物难治性复发性阵发性心房颤动（AFib）的Varipulse平台。。

About the Varipulse Platform

关于Varipulse平台

The Varipulse Platform is comprised of the Varipulse Catheter, a variable-loop multielectrode catheter; the TRUPULSE Generator, a multichannel PFA generator; and CARTO 3 System, a 3D cardiac mapping system.

Varipulse平台由Varipulse导管，可变环多电极导管组成；TRUPULSE发生器，一种多通道PFA发生器；和CARTO 3系统，一个3D心脏映射系统。

The Varipulse Platform is the first and only CARTO-integrated PFA system, enabling an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

Varipulse平台是第一个也是唯一一个与CARTO集成的PFA系统，可以通过实时可视化和反馈机制实现直观且可重复的工作流程。

'At Biosense Webster, we are working to deliver a differentiated PFA portfolio integrated with 3D cardiac mapping to address the real-world, unmet needs of electrophysiologists and the patients they treat. Today, we celebrate this milestone approval of the Varipulse Platform, the first and only PFA system approved in Japan,' said Jasmina Brooks, President, Biosense Webster.

“在Biosense Webster，我们正在努力提供与3D心脏映射相结合的差异化PFA组合，以满足电生理学家及其治疗患者的现实需求。Biosense Webster总裁贾斯米娜·布鲁克斯（JasminaBrooks）说，今天，我们庆祝Varipulse平台的这一里程碑式的批准，这是日本第一个也是唯一一个获得批准的PFA系统。

'We are excited to continue to advance PFA clinical studies globally and look forward to the positive impact this innovation will deliver to patients everywhere.'.

“我们很高兴继续在全球推进PFA临床研究，并期待这项创新将为世界各地的患者带来积极影响。”。

Clinical Results with the Platform

平台的临床结果

The inspIRE trial early clinical results with the Varipulse Platform in Europe demonstrated a one-year clinical success of 78.9%, defined as freedom from documented symptomatic atrial arrhythmia recurence.1 The trial also demonstrated a notable safety profile, reporting no primary adverse events (0%)1. .

inspIRE试验在欧洲使用Varipulse平台的早期临床结果显示，一年的临床成功率为78.9%，定义为无症状性房性心律失常复发[1]。该试验还显示出显着的安全性，未报告原发性不良事件（0%）1。。。

The platform's proprietary pulse sequence, catheter design, and CARTO 3 System integration enabled a simplified workflow and resulted in minimal fluoroscopy time (7.8 minutes) and efficient procedures (70 minutes)1.

该平台专有的脉冲序列，导管设计和CARTO 3系统集成简化了工作流程，减少了透视时间（7.8分钟）和高效程序（70分钟）1。

'The approval of ablation therapy using pulsed-field energy in Japan will further advance the treatment of arrhythmias. Together with the integrated 3D mapping system, this innovation has the potential to provide more advanced treatment and further improve safety,' said Dr. Wataru Shimizu, President of the Japan Heart Rhythm Society (Professor, Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School).

“日本批准使用脉冲场能量进行消融治疗将进一步推进心律失常的治疗。日本心律学会会长清水渡（Wataru Shimizu）博士（日本医学院医学研究生院心血管医学系教授）说，与集成的3D绘图系统一起，这项创新有可能提供更先进的治疗并进一步提高安全性。

'The increasing diversity of treatment technologies means that healthcare providers who seek to cure atrial fibrillation have options tailored to each patient's condition.'.

“治疗技术日益多样化意味着寻求治疗心房颤动的医疗保健提供者可以根据每位患者的病情进行选择。”。

A New Approach to Treating AFib

治疗AFib的新方法

Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart by delivering either heat (radiofrequency ablation) or cold (cryoablation).

导管消融是一种由电生理学家进行的微创手术，通过传递热量（射频消融）或冷（冷冻消融）来中断心脏不规则的电通路，从而治疗心律失常，包括AFib。

PFA represents a new approach to treating AFib, utilizing a controlled electric field to selectively ablate cardiac tissue that causes the irregular heartbeat through a process called irreversible electroporation (IRE). Because the pulsed field energy is minimally thermal, IRE offers the potential to reduce the risk of damage to surrounding tissues including esophageal, pulmonary vein, and phrenic nerve injury.2 .

PFA代表了一种治疗AFib的新方法，利用受控电场选择性消融心脏组织，通过称为不可逆电穿孔（IRE）的过程引起不规则的心跳。由于脉冲场能量是最小的热量，IRE有可能降低周围组织损伤的风险，包括食管，肺静脉和膈神经损伤。2。。

AFib is the most common type of cardiac arrhythmia, impacting nearly 38 million people worldwide and approximately 1.3 million people in Japan.3,4 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options and the importance of early treatment to avoid risk of stroke and disease progression.5 .

AFib是最常见的心律失常类型，影响全球近3800万人和日本约130万人[3,4]。尽管有这些预测，但许多人不熟悉AFib症状，可用的治疗选择以及早期治疗的重要性，以避免中风和疾病进展的风险。。

The Varipulse Platform is pending CE mark in the European Union; it is not available for sale in the EU or United States.

Varipulse平台正在欧盟进行CE认证；它不可在欧盟或美国销售。

More Biosense Webster News

更多Biosense Webster新闻

In September, Biosense Webster Inc. completed enrollment in the SmartfIRE study.

9月，Biosense Webster Inc.完成了SmartfIRE研究的注册。

In December, Biosense Webster revealed the first patient cases using its investigational Dual Energy ThermoCool SmartTouch SF (Dual Energy STSF) catheter.

12月，Biosense Webster使用其研究性双能ThermoCool SmartTouch SF（双能STSF）导管揭示了第一例患者病例。

References:

参考文献：

1 Duytschaever M, et al. Circ Arrhythm Electrophysiol. 2023;13(3):e011780. 3. Aguilar M, et al. Circulation. 2022;145(1):21–30

1 Duytschaever M等人。Circ心律失常电生理学。2023年；13（3）：e011780.3。Aguilar M等人，《循环》。2022年；145（1）：21-30

2 Reddy VY, Neuzil P, Koruth JS, et al. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. JACC 2019;74(3)315-326.

2 Reddy VY，Neuzil P，Koruth JS等。心房颤动肺静脉隔离的脉冲场消融。JACC 2019；74（3）315-326。

3 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870.

3 Lippi G，Sanchis Gomar F，Cervellin G.心房颤动的全球流行病学：日益严重的流行病和公共卫生挑战。Int J笔划。2021年2月；16（2）：217-221。内政部：10.1177/1747493019897870。

4 Economic Burden of Atrial Fibrillation in Japan. Value in Health 2018; 21(2)S70. doi: 10.1016/j.jval.2018.07.530.

4日本心房颤动的经济负担。2018年健康价值；21（2）S70。doi:10.1016/j.jval.2018.07.530。

5 Kuck et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace 2021;23(3)362-369. PMID: 33330909

5 Kuck等。导管消融或药物治疗延迟心房颤动的进展：随机对照心房颤动进展试验（EXTEST）。欧洲空间2021；23（3）362-369。PMID:33330909