New CARTO™ 3 System Version 8 software introduces machine learning capabilitiesIncreases efficiency, reproducibility, and accuracyi in the electro-anatomical maps electrophysiologists use in catheter ablation proceduresIRVINE, Calif., May 8, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announces the launch of CARTO™ 3 System Version 8, the latest version of the company's leading three-dimension (3D) heart mapping system used in cardiac ablation procedures.

新的CARTO™3系统第8版软件引入了机器学习功能，提高了电生理学家在导管消融过程中使用的电解剖图的效率，可重复性和准确性。加利福尼亚州雷瑟文，2024年5月8日/PRNewswire/--Biosense Webster，Inc.，心律失常治疗的全球领导者，强生医疗技术公司的一部分，宣布推出CARTO™3系统第8版，这是该公司领先的用于心脏消融程序的三维（3D）心脏映射系统的最新版本。

The software features new modules including the CARTO ELEVATE™ Module and CARTOSOUND™ FAM Module, designed for efficiency, reproducibility, and accuracy for electrophysiologists performing catheter ablation procedures to treat patients with atrial fibrillation (AFib) and other arrhythmias..

该软件具有包括CARTO ELEVATE™模块和CARTOSOUND™FAM模块在内的新模块，旨在为电生理学家进行导管消融治疗房颤（AFib）和其他心律失常患者的效率，可重复性和准确性而设计。。

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CARTO™ 3 System Version 8 features new modules including the CARTO ELEVATE™ Module and CARTOSOUND™ FAM Module, designed for efficiency, reproducibility, and accuracy for electrophysiologists performing catheter ablation procedures.

CARTO™3系统版本8具有新模块，包括CARTO ELEVATE™模块和CARTOSOUND™FAM模块，旨在为执行导管消融程序的电生理学家提供效率，可重复性和准确性。

'We are pleased to announce this new version of our CARTO™ 3 System, which reflects our continued focus on harnessing the latest science and technology to advance tools for electrophysiologists to treat cardiac arrhythmias,' said Jasmina Brooks, President, Biosense Webster, Inc. 'The CARTO™ 3 System has been the cornerstone of catheter ablation procedures for more than a decade, helping electrophysiologists make treatment decisions.

Biosense Webster，Inc.总裁贾斯米娜·布鲁克斯（JasminaBrooks）说：“我们很高兴宣布CARTO™3系统的新版本，这反映了我们继续专注于利用最新的科学和技术来推进电生理学家治疗心律失常的工具。”CARTO™3系统十多年来一直是导管消融程序的基石，帮助电生理学家做出治疗决策。

This new version advances the CARTO™ 3 mapping and ablation experience through enhanced signal analysis, improved substrate characterization, and utilization of ultrasound technology.'.

该新版本通过增强的信号分析，改进的基板表征和超声波技术的利用，提高了CARTO™3的映射和消融体验。”。

New optional CARTO™ 3 System Version 8 modules include:

新的可选CARTO™3系统版本8模块包括：

CARTOSOUND™ FAM: the first use of an artificial intelligence algorithm, cleared by the FDA in intracardiac ultrasound for Biosense Webster. The algorithm enables automatic generation of the left atrial anatomy before inserting the catheter to the left atrium, saving time while also providing a highly accurate map. CARTO ELEVATE™: incorporates several new features designed to meet electrophysiologists' needs:.

CARTOSOUND™FAM：首次使用人工智能算法，该算法已被FDA批准用于Biosense Webster的心内超声。该算法能够在将导管插入左心房之前自动生成左心房解剖结构，节省了时间，同时还提供了高度准确的地图。CARTO ELEVATE™：结合了几个新功能，旨在满足电生理学家的需求：。

Multipolar with the OPTRELL™ Mapping Catheter for localized unipolar signals to significantly reduce far field potentials and provide a more accurate activation map;ii

多极与OPTRELL™映射导管用于局部单极信号，以显着降低远场电位并提供更准确的激活图；二

Complex signals identification for efficient and reproducible identification of critical areas of interest when diagnosing the arrhythmia;i

复杂信号识别，用于在诊断心律失常时有效且可重复地识别感兴趣的关键区域；我

Pattern acquisition to automatically track arrhythmia burden pre- and post-ablation, enabling a more informed decision of the relevant premature activation map; and

模式采集可自动跟踪消融前后的心律失常负担，从而能够更明智地决定相关的过早激活图；和

Enhanced CONFIDENSE™ Module to create optimized maps with higher overall Smart Index scores, ensuring maps are continuously improved.iii

增强的CONFIDENSE™模块可创建具有更高整体Smart索引分数的优化地图，确保地图不断改进。iii

'CARTO™ 3 System Version 8 incorporates a novel component, the CARTOSOUND™ FAM Module, which, for the first time, utilizes artificial intelligence to reconstruct the left atrial anatomy, streamlining the process for electrophysiologists,'1,2,iv said Luigi Di Biase, M.D.v, PhD, FACC, FHRS, FESC, System Director Electrophysiology at Montefiore-Einstein Health System and Professor of Medicine (Cardiology), Albert Einstein College of Medicine.

“CARTO™3系统版本8包含了一个新组件CARTOSOUND™FAM模块，该模块首次利用人工智能重建左心房解剖结构，简化了电生理学家的过程，'1,2，iv说Luigi Di Biase，M。D、 v，博士，FACC，FHRS，FESC，Montefiore-Einstein健康系统的系统主任电生理学和阿尔伯特·爱因斯坦医学院医学（心脏病学）教授。

'By eliminating the need for manual contouring, the new system represents a new approach to anatomy creation, improving the efficiency of the procedure workflow.''Accuracy and precision in mapping the heart when treating cardiac arrhythmias are critical for electrophysiologists, and therefore, our patients,' continued Dr.

“通过消除手动轮廓的需要，新系统代表了一种新的解剖学创建方法，提高了手术工作流程的效率。”“在治疗心律失常时，绘制心脏图的准确性和精确度对于电生理学家至关重要，因此，我们的患者也是如此，”Dr。

Di Biase. 'The CARTO ELEVATE™ Module raises the bar for electro-anatomical mapping systems used in catheter ablation procedures. Capabilities such as Multipolar mapping make a difference for electrophysiologists in the electrophysiology lab, facilitating a reduction in far-field signal and increased focus on the electrical signals in the patient's heart that contribute to arrhythmias.'viAFib is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide.vii Catheter ablation is a safe and effective procedure when drugs don't work to help restore the heart's incorrect electrical signals, which cause an abnormal heart rhythm.viiiAbout CARTO™ 3 System Version 8The CARTO™ 3 System is a three-dimensional mapping system that uses electromagnetic technology to generate real-time maps of a patient's cardiac structures.

“Di Biase”CARTO ELEVATE™模块为导管消融程序中使用的电解剖标测系统提高了标准。多极标测等功能为电生理实验室的电生理学家带来了变化，有助于减少远场信号，并更加关注患者心脏中导致心律失常的电信号。”viAFib是最常见的心律失常类型，影响美国800多万人和全世界近5000万人。vii当药物无法帮助恢复心脏不正确的电信号时，导管消融是一种安全有效的程序，导致心律异常。viiiAbout CARTO™3系统版本8 CARTO™3系统是一种三维映射系统，使用电磁技术生成患者心脏结构的实时映射。

First launched in 2009, the system is designed to help electrophysiologists navigate the heart by generating 3D maps and pinpoi.

该系统于2009年首次推出，旨在通过生成3D地图和精确定位来帮助电生理学家导航心脏。

Media contact:Diane Pressman Dpressm1@its.jnj.com    Charlene DeBar Cdebar1@its.jnj.com

媒体联系人：Diane PressmanDpressm1@its.jnj.com沙琳·德巴尔Cdebar1@its.jnj.com

Investor Relations contact: Tracy Menkowski investor-relations@its.jnj.com

投资者关系联系人：Tracy Menkowskiinvestor-relations@its.jnj.com

i 91% of cases (n=27) the new algorithm identified critical isthmuses that may have result in successful ablation of all inducible atrial arrhythmias.ii Compared to previous version of CARTO™ 3 System software. The preclinical validation was conducted using retrospective analysis of 4 atrial flutter maps with or without pacing (2xRA and 2xLA) and 12 ventricular maps (3xVTs and 9x ischemic OPTRELL™ (part number D-1409) Catheter on CARTO™ 3 System.iii When using Smart Index mapping.

i 91%的病例（n=27）新算法确定了可能导致所有诱发性房性心律失常成功消融的关键峡部。ii与之前版本的CARTO™3系统软件相比。使用CARTO™3系统iii上的4个有或没有起搏的心房扑动图（2xRA和2xLA）和12个心室图（3xVTs和9x缺血性OPTRELL™（零件号D-1409）导管进行临床前验证。使用智能指数映射。

Optimized maps are referred to as overall higher Smart Index score indicating the quality of the map. 25 out of 25 cases used to evaluate the performance the Enhanced ConfiDENSE algorithm passed the acceptance criteria.iv CARTOSOUND™ FAM Module uses Deep Learning, which is a subset of AIv Dr. Luigi Di Biase is compensated by and presenting on behalf of BWI and must present information in accordance with applicable regulatory requirements.vi The preclinical validation was conducted using retrospective analysis of 4 atrial flutter maps and 12 ventricular maps collected from clinical cases.

优化的地图被称为总体较高的Smart指数分数，表明地图的质量。在用于评估性能的25个案例中，增强型ConfiDENSE算法通过了验收标准。iv CARTOSOUND™FAM模块使用深度学习，这是AIv Dr的一个子集。Luigi Di Biase由BWI补偿并代表BWI提供，并且必须根据适用的监管要求提供信息。vi临床前验证是通过回顾性分析从临床病例中收集的4个心房扑动图和12个心室图进行的。

All maps were created with the OPTRELL™ Catheter on CARTO™ 3 System.vii Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473.viii Calkins, et al. 2017 HRS_EHRA_ECAS_APHRS_SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.

所有地图均使用CARTO™3系统上的OPTRELL™导管创建。vii Mensah，G，Fuster，V，Murray，C。等人，《1990-2022年全球心血管疾病和风险负担》。J Am Coll Cardiol。2023年12月，82（25）2350–2473.viii Calkins等人2017 HRS\U EHRA\U ECAS\U APHRS\U SOLAECE关于心房颤动导管和手术消融的专家共识声明。

Heart Rhythm. 2017 October ; 14(10): e275–e444. doi:10.1016_j.hrthm.2017.05.012ix Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's MedTech segment. .

心律。2017年10月；14（10）：e275–e444。doi:10.1016\u j。hrthm。2017.05.012ix强生医疗科技公司（Johnson＆Johnson MedTech）包括强生医疗科技部门内的外科、骨科、视力和介入解决方案业务。

1 Di Biase L, Zou F, Lin AN, et al. Feasibility of Three-Dimensional Artificial Intelligence Algorithm Integration with Intracardiac Echocardiography for Left Atrial Imaging During Atrial Fibrillation Catheter Ablation. Europace. 2023 Aug 2;25(9):euad211.2 CARTOSOUND™ FAM Module Instructions for Use.

1 Di Biase L，Zou F，Lin AN，et al。三维人工智能算法与心内超声心动图相结合用于心房颤动导管消融期间左心房成像的可行性。欧洲空间。2023年8月2日；25（9）：euad211.2 CARTOSOUND™FAM模块使用说明。

UG_5462-00A. February 2024 .

UG\U 5462-00A。2024年2月。

SOURCE Biosense Webster

来源Biosense Webster