强生医疗技术公司在美国推出SOUNDSTAR CRYSTAL™，重新定义二维心内成像的图像清晰度-动脉网

Johnson & Johnson MedTech Launches SOUNDSTAR CRYSTAL™ in the US, Redefining Image Clarity in 2D Intracardiac Imaging

CISION 等信源发布 2025-05-21 20:30

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可切换为仅中文

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New ultrasound catheter delivers superior image quality,

新型超声导管提供更优的图像质量，

i,ii

一、二

peak maneuverability and seamless CARTO™ 3 System integration

极致的操控性和无缝的CARTO™ 3系统集成

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, giving physicians improved visualization

，让医生获得更好的可视化效果

二

for added confidence during cardiac ablation procedures

为了在心脏消融手术中增加信心

IRVINE, Calif.

尔湾，加利福尼亚州

，

May 21, 2025

2025年5月21日

/PRNewswire/ -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the U.S. launch of the SOUNDSTAR CRYSTAL™ Ultrasound Catheter for intracardiac echocardiography (ICE) imaging in cardiac ablation procedures.

/PRNewswire/ -- 全球心脏心律失常治疗领域的领导者强生医疗科技宣布，在美国推出用于心脏消融手术中心内超声心动图（ICE）成像的SOUNDSTAR CRYSTAL™ 超声导管。

The device provides clearer, enhanced image quality compared to other ICE catheters

该设备提供比其他ICE导管更清晰、更高质量的图像。

, representing an advanced 2D ICE catheter. Integrated with CARTO™ 3 Mapping System

，代表一种先进的二维ICE导管。与CARTO™ 3映射系统集成。

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, including the CARTOSOUND™ FAM module for enhanced mapping capabilities powered by AI

，包括由人工智能驱动的CARTOSOUND™ FAM模块以增强映射能力

,iii

，iii

, SOUNDSTAR CRYSTAL™ provides an efficient workflow

，SOUNDSTAR CRYSTAL™ 提供了高效的工作流程

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. CARTOSOUND™ FAM enables automatic generation of the left atrial anatomy by a novel artificial intelligence algorithm using images collected from a rotation of the ultrasound catheter in the right atrium, simplifying the integrated workflow

CARTOSOUND™ FAM通过一种新颖的人工智能算法，利用从右心房旋转的超声导管收集的图像，实现左心房解剖结构的自动生成，简化了集成工作流程。

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for electrophysiologists performing cardiac ablation procedures for patients

为患者进行心脏消融手术的电生理学家

。

'We are proud to advance our legacy in integrated ultrasound catheters with this latest innovation that equips electrophysiologists with the tools they need to promote patient safety

“我们为在集成超声导管领域的传承感到自豪，这项最新的创新为电生理学家提供了他们所需的工具，以促进患者的安全。

and drive effective

并推动有效

四

results,' said

结果，”说

Jasmina Brooks

贾斯米娜·布鲁克斯

, President, Electrophysiology, Johnson & Johnson MedTech. 'The superior image quality

，总裁，电生理学，强生医疗科技。‘卓越的图像质量

i,ii

一、二

, improved catheter maneuverability

，提高了导管的可操控性

and stability of the SOUNDSTAR CRYSTAL™ Ultrasound Catheter, along with seamless CARTO™ 3 System integration

SOUNDSTAR CRYSTAL™ 超声波导管的稳定性和与 CARTO™ 3 系统的无缝集成

can help enable a zero fluoroscopy workflow

可以帮助实现零荧光透视工作流程

iv,v,

四、五、

†

,2,3,4,vi

`,2,3,4,vi`

, enhancing procedure effectiveness and safety for both healthcare professionals and patients they treat.'

`, 提高了医疗专业人员和他们治疗的患者的程序有效性和安全性。`

ICE is broadly used in catheter ablation procedures to visualize the heart in high resolution to monitor catheter-tissue contact and ablation in real-time and quickly detect procedural complications. When real-time imaging is integrated with a 3D electroanatomical mapping system, such as the CARTO™ 3 System, ICE can help reconstruct cardiac anatomy and enable zero-fluoroscopy procedures.

ICE（心腔内超声）在导管消融手术中被广泛用于高分辨率地观察心脏，实时监控导管与组织的接触及消融情况，并快速检测手术并发症。当实时成像与三维电生理标测系统（如CARTO™ 3系统）结合时，ICE可以帮助重建心脏解剖结构，并实现零射线手术。

†

，2

，

. ICE-guided electrophysiology procedures can be performed under conscious sedation, without requiring esophageal intubation and additional anesthesia

在ICE引导下的电生理学手术可以在清醒镇静下进行，无需食管插管和额外麻醉。

vii,5

。

'During the cases I performed with the SOUNDSTAR CRYSTAL™ Ultrasound Catheter, I was impressed by the clear visualization, tissue definition and enhanced far field imaging

“在使用SOUNDSTAR CRYSTAL™超声导管进行的病例中，我对其清晰的可视化、组织定义和增强的远场成像印象深刻。”

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, and full integration with other platforms. Integration with the CARTO™ 3 System provides clear, high-resolution images

，并且与其他平台完全集成。与CARTO™ 3系统的集成为高分辨率图像提供了清晰度。

i,viii

一，八

which simplify the anatomical mapping process

简化了解剖映射过程

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and procedure workflow

和程序工作流程

,' said

“，”说

Amin Al-Ahmad

阿明·阿尔-艾哈迈德

, MD

，医学博士

, St. David's HealthCare,

，圣大卫医疗保健，

Austin, TX.

德克萨斯州奥斯汀市。

The SOUNDSTAR CRYSTAL™ Ultrasound Catheter is the latest addition to a comprehensive portfolio of ultrasound solutions at Johnson & Johnson MedTech. The company recently brought forward the

SOUNDSTAR CRYSTAL™ 超声波导管是强生医疗科技公司超声解决方案综合产品组合中的最新成员。该公司最近推出了这款产品。

NUVISION™ Catheter

NUVISION™ 导管

, which harnesses advanced 4D imaging to assist physicians performing cardiac procedures, such as Left Atrial Appendage Closure (LAAC).

，它利用先进的4D成像技术来协助医生进行心脏手术，例如左心耳封堵术（LAAC）。

Cardiac arrhythmias are a growing epidemic. AFib alone is the most common type of cardiac arrhythmia and impacts more than 50 million people worldwide, and 8 million people in the U.S

心律失常的发病率正在不断上升，单是房颤就属于最常见的心律失常类型，影响着全球逾5000万人，而美国则有800万人受其影响。

. AFib is a progressive disease, and if left untreated can get worse over time or lead to other serious complications like heart disease or stroke

心房颤动是一种进行性疾病，如果不治疗，会随着时间的推移而恶化，或导致其他严重并发症，如心脏病或中风。

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. Catheter ablation is a safe and effective procedure to restore the heart's incorrect electrical signals, which causes an abnormal heart rhythm

导管消融是一种安全有效的手术，可以修复心脏的错误电信号，从而导致心律异常。

。

About SOUNDSTAR CRYSTAL™

关于SOUNDSTAR CRYSTAL™

SOUNDSTAR CRYSTAL™ is an ultrasound catheter that features an 88-element phased linear array to deliver outstanding image quality and detailed visualization of intricate anatomical structures inside the hearti. SOUNDSTAR CRYSTAL™ is integrated with the CARTO™ 3 System for a cohesive and efficient workflow during catheter ablation procedures.

SOUNDSTAR CRYSTAL™ 是一种超声波导管，具有 88 元件相控线性阵列，能够提供卓越的图像质量和心脏内部复杂解剖结构的详细可视化。SOUNDSTAR CRYSTAL™ 与 CARTO™ 3 系统集成，在导管消融手术过程中提供连贯且高效的工作流程。

The catheter also is designed with optimal balance of stiffness and flexibility, ensuring precision in maneuverability.

导管还设计有最佳的硬度和柔韧性平衡，确保操作的精确性。

我

。

Cardiovascular Solutions from Johnson & Johnson MedTech

来自强生医疗科技的心血管解决方案

Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation.

在强生公司，我们正在应对世界上最复杂和普遍的健康挑战。通过心血管产品组合，我们为医疗保健专业人员提供先进的标测和导航、微型技术和精确消融技术，我们正在解决那些存在重大未满足需求的疾病，如心力衰竭、冠状动脉疾病、中风和心房颤动。

We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit .

我们是心脏康复、循环系统修复和心律失常治疗的全球领导者，同时也是神经血管护理领域新兴的领导者，致力于攻克心力衰竭和中风这两大全球主要死亡原因。欲了解更多信息，请访问。

biosensewebster.com

and connect on

连接到

领英

and

和

X, formerly Twitter

X，原名Twitter

。

About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

在强生，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且更少侵入性，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今全面的医疗保健解决方案领域进行创新，以提供未来的突破，并对人类健康产生深远影响。

Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision and cardiovascular solutions at .

了解更多关于我们医疗技术领域在全球范围内的规模以及在手术、骨科、视力和心血管解决方案方面的深厚专业知识。

https://thenext.jnjmedtech.com

. Follow us at

关注我们

@JNJMedTech

and on

并且继续

领英

. Biosense Webster, Inc. is a Johnson & Johnson MedTech company.

Biosense Webster, Inc. 是强生医疗科技公司的一员。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding SOUNDSTAR CRYSTAL™. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson.

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于SOUNDSTAR CRYSTAL™的“前瞻性声明”。这些声明基于对未来事件的当前预期。如果基本假设被证明不准确或已知或未知的风险或不确定性变为现实，实际结果可能与强生公司的预期和预测大相径庭。

Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment.

风险和不确定性包括但不限于：监管审批的不确定性；商业成功的不确定性；专利挑战；竞争，包括技术进步、竞争对手获得的新产品和专利；产品功效或安全问题导致的产品召回或监管行动；适用法律法规的变更，包括全球医疗保健改革；医疗保健产品和服务购买者的行为及支出模式的变化；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性和其他因素的进一步列表和描述，请参见强生公司最近的年度报告 Form 10-K，包括标题为“关于前瞻性陈述的警示声明”和“项目1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和其他提交给证券交易委员会的文件。

Copies of these filings are available online at , .

这些文件的副本可在线获取，网址为，。

jnj.com

强生公司官网

or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.sec.gov,

或应Johnson & Johnson的要求。Johnson & Johnson不承担因新信息、未来事件或发展而更新任何前瞻性声明的义务。sec.gov,

jnj.com

强生公司官网

or on request from Johnson & Johnson.

或应强生公司的要求。

我

Based on Siemens' internal report CRF data responses as of 8/9/2024. CRF Data PN 11291187-EPT-021.

基于西门子内部报告CRF数据回复，截至2024年8月9日。CRF数据零件号11291187-EPT-021。

二

When compared to [ACUSON AcuNav™ Ultrasound Catheter] [SOUNDSTAR™ Ultrasound Catheter]

与[ACUSON AcuNav™ 超声导管] [SOUNDSTAR™ 超声导管]相比

iii

CARTOSOUND™ FAM Module uses Deep Learning, which is a subset of AI

CARTOSOUND™ FAM 模块使用深度学习，这是人工智能的一个子集。

四

Safety profile refers to complication and primary adverse event rates

安全性概况是指并发症和主要不良事件的发生率。

†Efficacy profile refers to acute success (pulmonary vein isolation) and long-term success.

疗效概况是指急性成功（肺静脉隔离）和长期成功。

Based on a survey of 31 physicians.

基于对31名医生的调查。

Johnson & Johnson and its affiliates' portfolio of products with FDA approved/cleared instructions for use to support fluoro alternative workflows when used with the CARTO™ 3 System include the following: THERMOCOOL SMARTTOUCH™ SF Catheter, THERMOCOOL SMARTTOUCH™ Catheter, CARTO™ VIZIGO™ Bi-Directional Guiding Sheath, PENTARAY™ NAV ECO High Density Mapping Catheter, OCTARAY™ Mapping Catheter with TRUEref™ Technology, OPTRELL™ Mapping Catheter with TRUEref™ Technology, DECANAV™ Mapping Catheters, and Webster™ CS Catheter..

强生公司及其关联公司拥有FDA批准/核准的使用说明的产品组合，当与CARTO™ 3系统配合使用时，可支持荧光替代工作流程，包括以下产品：THERMOCOOL SMARTTOUCH™ SF导管、THERMOCOOL SMARTTOUCH™ 导管、CARTO™ VIZIGO™ 双向引导鞘、PENTARAY™ NAV ECO高密度标测导管、带有TRUEref™技术的OCTARAY™ 标测导管、带有TRUEref™技术的OPTRELL™ 标测导管、DECANAV™ 标测导管和Webster™ CS导管。

vii

七

Based on a meta analysis of ICE applications in EP

基于对EP中ICE应用的荟萃分析

viii

八

When compared to SOUNDSTAR™ Catheter

与SOUNDSTAR™导管相比

九

Based on 96 surveys, by 31 EPs with an average score of 5.0 or higher on 7-point Likert scale with 5=Satisfied 6/7=Completely Satisfied

基于96份调查，由31位EP完成，平均得分在7点李克特量表上达到5.0或更高，其中5=满意，6/7=完全满意。

Dr. Al-Ahmad serves as a consultant for Johnson & Johnson but was not compensated for this announcement.

阿尔·艾哈迈德博士是强生公司的顾问，但并未因这一声明获得报酬。

CARTOSOUND™ FAM Module Instructions for Use. UG_5462-018H P02.

CARTOSOUND™ FAM模块使用说明书。UG_5462-018H P02。

November 2023

2023年11月

。

Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389/fcvm.2023.1178783.

德布勒森D，亚诺希K，博茨B，等（2023）。零透视导管消融治疗心房颤动：系统评价与荟萃分析。《心血管医学前沿》；10:1178783。doi: 10.3389/fcvm.2023.1178783。

Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007/s10840-022-01332-8.

Rajendra A, Hunter TD, Morales GX 等 (2023)。在三维电解剖标测下可显影的可操控鞘管有助于以极低透视完成阵发性心房颤动消融。《介入心脏病学与电生理学杂志》；66(2):381-388。doi: 10.1007/s10840-022-01332-8。

Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186/s12872-021-02219-8.

Tahin T, Riba A, Nemeth B, 等 (2021). 使用简化的心腔内超声心动图引导方法实施零透视工作流程进行房颤导管消融，包括重复手术。《BMC心血管疾病》;21(1):407. doi: 10.1186/s12872-021-02219-8.

Tong Hu, Tongshuai Chen, Kellina Maduray,

胡彤，陈通帅，凯莉娜·马杜雷，

Wenqiang Han

韩文强

Jingquan Zhong

钟敬泉

. Intracardiac Echocardiography: An Invaluable Tool in Electrophysiological Interventions for Atrial Fibrillation and Supraventricular Tachycardia. Rev. Cardiovasc. Med. 2024, 25(6), 191.

心腔内超声心动图：心房颤动和室上性心动过速电生理干预中的宝贵工具。《心血管医学评论》，2024年，第25卷第6期，第191页。

https://doi.org/10.31083/j.rcm2506191

。

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.

门萨，G，富斯特，V，默里，C. 等。1990-2022年全球心血管疾病与风险负担。《美国心脏病学会杂志》。2023年12月，第82卷，第25期，2350-2473页。

Calkins, H., et al (2017). 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart rhythm, 14(10), e275–e444.

卡尔金斯，H. 等（2017）。2017 HRS/EHRA/ECAS/APHRS/SOLAECE 关于心房颤动导管和手术消融的专家共识声明。《心律》，14(10)，e275–e444。

Odutayo, A. et al (2016). Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ (Clinical research ed.), 354, i4482.

奥杜塔约，A. 等（2016）。心房颤动与心血管疾病、肾病和死亡风险：系统评价与荟萃分析。《英国医学杂志》（临床研究版），354，i4482。

Natale, A. et al (2014). Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 64(7), 647–656.

纳塔莱，A. 等（2014）。使用接触力感应导管进行阵发性房颤导管消融：前瞻性多中心SMART-AF试验的结果。《美国心脏病学会杂志》，64(7)，647-656。

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