Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, today announced European CE mark approval of the VARIPULSE™ Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AF) using pulsed field ablation (PFA).

全球心律失常治疗领导者、强生医疗科技（Johnson＆Johnson MedTech）的一部分Biosense Webster，Inc.今天宣布欧洲CE标志批准VARIPULSE™平台，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（AF）。

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.

VARIPULSE™平台由VARIPULSE™导管和可变回路多电极导管组成；TRUPULSE™发生器，一种多通道PFA发生器；和CARTO™3系统，世界领先的3D心脏绘图系统。VARIPULSE™平台是第一个也是唯一一个集成了CARTO™的PFA系统，通过实时可视化和反馈机制实现了直观且可重复的工作流程。

The safety and efficacy of the VARIPULSE™ Platform was investigated in the inspIRE trial, which included 186 patients in Canada and Europe.[1] Updated one-year follow-up data was presented this month at the AF Symposium in Boston, demonstrating that among participants receiving optimal PFA applications, 80% achieved freedom from recurrence with zero primary adverse events.[2]** Furthermore, the primary effectiveness endpoint (PEE) of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, Atrial Tachycardia, or Atrial Flutter) was 75.6%.[2] The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the VARIPULSE™ Catheter to the CARTO™ 3 System and a good safety profile with no (0.0%) primary adverse events reported.

inspIRE试验研究了VARIPULSE™平台的安全性和有效性，该试验包括加拿大和欧洲的186名患者。[1] 本月在波士顿举行的AF研讨会上提供了最新的一年随访数据，表明在接受最佳PFA应用的参与者中，80%的患者无复发，无原发性不良事件。[2] **此外，急性肺静脉隔离和12个月无房性心律失常复发（房颤，房性心动过速或心房扑动）的主要有效终点（PEE）为75.6%。[2] 该研究报告的低透视时间为7.8分钟，部分原因是VARIPULSE™导管与CARTO™3系统的整合以及良好的安全性，未报告（0.0%）主要不良事件。

'CE mark approval of the VARIPULSE™ Platform represents a significant advance in catheter ablation technology, allowing electrophysiologists to offer patients in Europe pulsed field ablation treatment with real-time integrated 3D mapping,' said Tom De Potter,***MD, Associate Director, Cardiovascular Center, OLV Hospital Aalst, Belgium.

比利时奥尔夫奥尔斯特医院心血管中心副主任、医学博士汤姆·德波特（Tom De Potter）说：“CE标志对VARIPULSE™平台的批准代表了导管消融技术的重大进步，使电生理学家能够为欧洲的患者提供具有实时集成3D映射的脉冲场消融治疗。”

'Significantly, the VARIPULSE™ Platform is fully integrated with the CARTO™ 3 System, enabling a simplified workflow with minimal fluoroscopy time. Most importantly, the recent published data on the VARIPULSE™ Platform demonstrates the safety using pulsed field ablation for patients being treated for AF.'.

“值得注意的是，VARIPULSE™平台与CARTO™3系统完全集成，简化了工作流程，缩短了透视时间。最重要的是，VARIPULSE™平台上最近公布的数据证明了使用脉冲场消融治疗房颤患者的安全性。

Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AF, by interrupting irregular electrical pathways in the heart by delivering either heat (radiofrequency ablation) or cold (cryoablation).[3] PFA represents a new approach to treating AF, utilizing a controlled electric field to selectively ablate cardiac tissue that causes the irregular heartbeat through a process called irreversible electroporation (IRE).[4] 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.[4]'At Biosense Webster, we continually seek to push the boundaries of science and technology innovation in cardiac ablation.

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）来中断心脏中不规则的电通路，从而治疗心律失常，包括房颤。[3] PFA代表了一种治疗房颤的新方法，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。[4] 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。[4] “在Biosense Webster，我们不断寻求推动心脏消融科学技术创新的界限。

CE mark approval of the VARIPULSE™ Platform is testament to this, now offering healthcare professionals the potential to improve outcomes for people living with atrial fibrillation while setting a new standard in cardiac electrophysiological mapping,' said Jasmina Brooks, President, Biosense Webster.

Biosense Webster总裁贾斯米娜·布鲁克斯（JasminaBrooks）说，CE mark对VARIPULSE™平台的批准证明了这一点，现在为医疗保健专业人员提供了改善房颤患者预后的潜力，同时为心脏电生理标测制定了新标准。

'We believe pulsed field ablation has the potential to offer safer, more consistent and efficient workflows, and the VARIPULSE™ Platform uniquely offers physicians a simple and reproducible PFA workflow with 3D visualization, in real-time.'AF is the most common type of cardiac arrhythmia, affecting over 11 million people in Europe.[5],[6],[7] If left untreated, patients face a fivefold increased risk of stroke[7], while their risk of death doubles[7].

房颤是最常见的心律失常类型，影响欧洲1100多万人。[5] ，[6]，[7]如果不及时治疗，患者中风风险增加五倍，而死亡风险增加一倍。

By 2030, prevalence is projected to increase by up to 70 percent[7] presenting an urgent need for innovative treatment solutions that deliver better outcomes for people living with AF while providing healthcare professionals wit.

到2030年，患病率预计将增加70%[7]，迫切需要创新的治疗方案，为房颤患者提供更好的治疗效果，同时为医疗保健专业人员提供智慧。