First regulatory approval for the first-of-its-kind, fully-integrated PFA system with a simple and reproducible workflow

首次获得监管部门的批准，这是同类产品中第一个完全集成的PFA系统，具有简单且可重复的工作流程

Integrated with the world's leading CARTO™ 3D cardiac mapping system for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib)

与世界领先的CARTO集成™ 3D心脏标测系统治疗症状性药物难治性复发性阵发性心房颤动（AFib）

First and only PFA system approved in Japan

日本第一个也是唯一一个获得批准的PFA系统

IRVINE, Calif., Jan. 9, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i today announced 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).

加利福尼亚州欧文，2024年1月9日/PRNewswire/--Biosense Webster，Inc.，全球心律失常治疗领导者，强生医疗科技公司的一部分，我今天宣布日本厚生劳动省（MHLW）批准VARIPULSE™ 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, the world's leading 3D cardiac mapping system. 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..

变压脉冲™ 平台由VARIPULSE组成™ 导管，可变环多电极导管；TRUPULSE™ 发生器，多通道PFA发生器；和CARTO™ 3系统，世界领先的3D心脏测绘系统。变压脉冲™ 平台是第一个也是唯一一个卡通™-集成PFA系统，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。。

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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, the world’s leading 3D cardiac mapping system.

变压脉冲™ 平台由VARIPULSE组成™ 导管，可变环多电极导管；TRUPULSE™ 发生器，多通道PFA发生器；和CARTO™ 3系统，世界领先的3D心脏测绘系统。

VARIPULSE LA Map

VARIPULSE LA地图

'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。今天，我们庆祝VARIPULSE的这一里程碑式的批准™ Biosense Webster总裁贾斯米娜·布鲁克斯（JasminaBrooks）说，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。”。

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试验使用VARIPULSE的早期临床结果™ 欧洲平台的一年临床成功率为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，无主要不良事件（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 innovation in catheter ablation therapy for atrial fibrillation has been remarkable. 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.

“心房颤动导管消融治疗的创新是显着的。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。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。

Wataru Shimizu, President of the Japan Heart Rhythm Society (Professor, Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School) ii. 'The increasing diversity of treatment technologies means that healthcare providers who seek to cure atrial fibrillation have options tailored to each patient's condition.'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).

日本心律学会会长清水渡郎（日本医学院医学研究生院心血管医学系教授）ii治疗技术的多样性日益增加，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。”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.2AFib 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.5The VARIPULSE™ Platform is pending CE mark in the European Union; it is no.

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。由于脉冲场能量的热量最小，因此IRE有可能降低周围组织（包括食管，肺静脉和膈神经损伤）受损的风险。2AFib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，许多人不熟悉AFib症状，可用的治疗选择以及早期治疗对避免中风和疾病进展风险的重要性。5 VARIPULSE™ 平台正在欧盟等待CE标志；它不是。

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SOURCE Biosense Webster

来源Biosense Webster