Final results from inspIRE study demonstrate 80% freedom from atrial arrhythmia recurrence at 12 months in patients with optimal Pulsed Field Ablation applications

inspIRE研究的最终结果表明，在最佳脉冲场消融应用的患者中，12个月时房性心律失常复发率为80%

First look results from admIRE study suggests similar outcomes

admIRE研究的第一眼结果表明类似的结果

IRVINE, Calif., Feb. 2, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced 12-month results from the company-sponsored inspIRE study, 'Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation (PFA) Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE,' presented as a late-breaking presentation at the 29th Annual International AF Symposium.1 Interim results from the company-sponsored admIRE study, titled 'PFA Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study,' were also shared in a late-breaking presentation.2.

加利福尼亚州欧文，2024年2月2日/PRNewswire/--全球心律失常治疗领导者、强生医疗技术公司（Johnson＆Johnson MedTechi）旗下的Biosense Webster，Inc.宣布了该公司赞助的inspIRE研究的12个月结果，“使用具有3D映射集成的可变环导管进行脉冲场消融（PFA）肺静脉隔离成功的预测因素：inspIRE的完整12个月结果”，在第29届年度国际房颤研讨会上作为最新的演示文稿发表。1公司赞助的admIRE研究的中期结果，标题为“使用具有3D映射集成的可变环圆形导管的PFA：admIRE研究的早期结果”也在一篇最新的演讲中分享。

Both the inspIRE and admIRE studies were conducted using the Biosense Webster VARIPULSE™ Platform, consisting of the VARIPULSE™ Catheter – a fully integrated variable-loop multielectrode catheter; the TRUPULSE™ Generator – a multichannel PFA generator; and the CARTO™ 3 System VARIPULSE™ Service Pack Software, which provides full integration with the world's leading 3D cardiac mapping system.

inspIRE和admIRE研究均使用Biosense Webster VARIPULSE进行™ 平台，由VARIPULSE组成™ 导管-完全集成的可变环多电极导管；TRUPULSE™ 发电机–多通道PFA发电机；还有纸箱™ 3系统变量脉冲™ Service Pack软件，可与世界领先的3D心脏绘图系统完全集成。

The CARTO™ System enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms..

卡通™ 该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。。

'Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures,' said Jasmina Brooks, President, Biosense Webster, Inc. 'The encouraging outcomes from clinical trials with VARIPULSE™ fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation.'.

Biosense Webster，Inc.总裁贾斯米娜·布鲁克斯（JasminaBrooks）说：“Biosense Webster致力于提出一套多功能、差异化的PFA解决方案组合，旨在帮助电生理学家提供安全、有效和高效的心脏消融程序。VARIPULSE临床试验取得了令人鼓舞的结果™ 随着我们继续提供创新，以满足成功治疗心房颤动所需的各种需求和消融策略，激发我们的兴奋。”。

Data from inspIRE Demonstrate 80% of Patients Achieved Freedom from Recurrence with Zero Primary Adverse Events

inspIRE的数据表明，80%的患者无复发，无原发性不良事件

The inspIRE study evaluated the safety and effectiveness of the VARIPULSE™ Platform for the treatment of drug-refractory paroxysmal AFib in Europe and Canada.1 In the study, the primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AFib, Atrial Tachycardia, or Atrial Flutter) was 75.6%.

inspIRE研究评估了VARIPULSE的安全性和有效性™ 欧洲和加拿大难治性阵发性AFib治疗平台。在该研究中，急性肺静脉隔离和12个月无房性心律失常复发（AFib，房性心动过速或心房扑动）的主要有效终点为75.6%。

Among participants receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint.1 The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the VARIPULSE™ Platform to the CARTO™ 3 System. The safety results demonstrated a primary adverse event rate of 0.0%ii.1  .

在接受最佳PFA应用的参与者中，80%达到了主要有效性终点。1该研究报告的透视时间较低，为7.8分钟，部分原因是VARIPULSE的整合™ 通往CARTO的平台™ 3系统。安全性结果显示主要不良事件发生率为0.0%ii.1。

'High efficacy of 80% freedom from atrial recurrence at 12 months and a strong safety profile are promising evidence of the capabilities of the VARIPULSE™ Platform,' said Vivek Y. Reddy, M.D., Director of Electrophysiology at the Mount Sinai Fuster Heart Hospital and The Helmsley Trust Professor of Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, corresponding author for the inspIRE study publication.iii 'As the VARIPULSE™ Platform was designed to integrate seamlessly with the CARTO™ 3 Mapping System, this technology should be able to effectively treat patients with atrial fibrillation with low radiation exposure to patients and lab staff alike.'.

“12个月时80%无心房复发的高效性和强大的安全性是VARIPULSE功能的有希望的证据™ 西奈山福斯特心脏医院电生理学主任、西奈山伊坎医学院赫尔姆斯利信托基金（Helmsley Trust）心脏电生理学教授、inspIRE研究出版物的通讯作者维韦克·雷迪（VivekY.Reddy）医学博士说™ 该平台旨在与CARTO无缝集成™ 3映射系统，这项技术应该能够有效地治疗房颤患者，低辐射暴露于患者和实验室工作人员。”。

admIRE Pilot Results Show All Pilot Phase Patients Achieved Acute Success and 80% Remained Free from Atrial Arrhythmia Recurrence After One Year

admIRE试点结果显示，所有试点阶段患者均取得了急性成功，80%的患者在一年后仍无房性心律失常复发

Twelve-month outcomes data from the pilot phase of the admIRE study, which assessed the safety and efficacy of the VARIPULSE™ Platform among U.S. patients, were presented as a late-breaker at the AF Symposium.2 Among 20 patients who completed the 12-month follow-up visit, 100% achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.2 No procedure or device-related primary adverse events were reported in the pilot phase of the study.2 For patients who had received ablation, median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively, as a result of the CARTO™ integration.2 .

admIRE研究试点阶段的12个月结果数据，该研究评估了VARIPULSE的安全性和有效性™ 在AF研讨会上，美国患者中的平台被认为是晚期破坏者。2在完成12个月随访的20名患者中，100%的消融手术取得了急性成功，80%的患者在一年内没有房性心律失常复发。2在研究的试验阶段没有报告与手术或设备相关的主要不良事件。2对于接受消融的患者，CARTO的中位手术和透视时间分别为90.0分钟和3.5分钟™ 整合。

'The results observed in the pilot phase of the admIRE study point to the promise of the VARIPULSE™ Platform in treating patients with paroxysmal AFib,' said David Newton, M.D., Clinical Cardiac Electrophysiologist, Memorial Health University Medical Center, Savannah, Georgia.iv 'These initial results are encouraging and demonstrate the potential for the VARIPULSE™ Platform to become a key component of the suite of tools electrophysiologists have at their disposal to perform catheter ablations.'.

“在admIRE研究的试点阶段观察到的结果表明了VARIPULSE的前景™ 佐治亚州萨凡纳纪念健康大学医学中心临床心脏电生理学家David Newton医学博士说，这些初步结果令人鼓舞，并证明了VARIPULSE的潜力™ 该平台将成为电生理学家可用于进行导管消融的一套工具的关键组成部分。”。

AFib is the most common type of cardiac arrhythmia and affects more than 6 million people in the United States and nearly 38 million people worldwide.3,4 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.5 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression.6 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.7.

AFib是最常见的心律失常类型，影响美国600多万人和全世界近3800万人。3,4 40岁以上的成年人中约有四分之一有患AFib的风险。5尽管有这些预测，许多人不熟悉AFib的症状，可用的治疗选择，以及早期治疗对避免疾病进展的重要性。6当药物无法帮助恢复导致心律异常的心脏不正确电信号时，导管消融是一种安全有效的方法。

About inspIREThe inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by PFA System With Irreversible Electroporation [IRE]) (NCT04524364) was a prospective, multi-center, single-arm study of drug-refractory PAF, conducted at 13 institutions in Canada and Europe, from March 2021 to May 2022.

关于inspIRE inspIRE研究（不可逆电穿孔PFA系统治疗阵发性心房颤动的研究）（NCT04524364）是一项前瞻性，多中心，单臂的药物难治性PAF研究，于2021年3月至2022年5月在加拿大和欧洲的13家机构进行。

In the study, PVI was performed with the VARIPULSE™ Platform. Follow up with 24-hour Holter monitoring was performed at three, six, and 12 months. Remote rhythm monitoring was performed weekly from three to five months; monthly, from six to 12 months; and for symptoms. The primary effectiveness endpoint (PEE) was acute PVI plus freedom from all atrial arrhythmia (AFib, Atrial Tachycardia, or Atrial Flutter), at 12 months.

在这项研究中，PVI是用VARIPULSE进行的™ 平台。在三个月，六个月和十二个月时进行了24小时动态心电图监测的随访。远程节律监测每周进行三到五个月；每月，从六个月到十二个月；以及症状。主要有效性终点（PEE）是12个月时急性PVI加上所有房性心律失常（AFib，房性心动过速或心房扑动）的自由。

This final analysis of the study focused on the pivotal phase (Wave II) per-protocol population of 186 patients with 12 months of follow up..

该研究的最终分析集中在186名患者的关键阶段（第二波），随访12个月。。

About admIREThe admIRE study (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Biosense Webster IRE Ablation System) (NCT05293639) is a prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the VARIPULSE™ Platform when used for isolation of pulmonary veins in treatment of patients in the United States with symptomatic drug refractory paroxysmal AFib.

关于ADMIRET admIRE研究（使用Biosense Webster IRE消融系统评估房颤治疗管理的安全性和有效性）（NCT05293639）是一项前瞻性，多中心，单臂研究，旨在证明VARIPULSE的安全性和长期有效性™ 该平台用于分离美国症状性药物难治性阵发性AFib患者的肺静脉。

Pulmonary vein isolation (PVI) was achieved using the VARIPULSE™ Platform. The study consisted of a pilot phase, which assessed initial device safety and effectiveness, and a pivotal phase, which assessed these against pre-specified performance goals. The primary safety endpoint was incidence of early onset (within seven days) primary adverse events; atrio-esophageal fistula (within 90 days); cardiac tamponade or perforation (within 30 days); and PV stenosis (within 12 months).

使用VARIPULSE实现肺静脉隔离（PVI）™ 平台。该研究包括一个试点阶段，评估初始设备的安全性和有效性，以及一个关键阶段，根据预先指定的性能目标评估这些。主要安全性终点是早期发作（7天内）主要不良事件的发生率；心房食管瘘（90天内）；心脏压塞或穿孔（30天内）；和PV狭窄（12个月内）。

Acute procedure success (defined as confirmed entrance block at the end of procedure) and freedom from documented atrial arrhythmia recurrence at 12 months were also assessed. .

还评估了急性手术成功率（定义为手术结束时确诊的入口阻滞）和12个月时记录的房性心律失常复发情况。。

About the VARIPULSE™ PlatformThe VARIPULSE™ Platform is Biosense Webster's Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE™ Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA.

关于VARIPULSE™ 平台VARIPULSE™ 该平台是Biosense Webster的不可逆电穿孔消融系统。完全集成的平台包括VARIPULSE™ 导管，TRUPULSE™ 发电机和CARTO™ 3映射系统VARIPULSE™ Service Pack软件。2024年1月，Biosense Webster宣布VARIPULSE™ 该平台首次获得日本厚生劳动省的监管批准，用于使用PFA治疗症状性药物难治性复发性阵发性AFib。

In the U.S., the VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory authorities. In Europe, the TRUPULSE™ generator received CE mark in late 2023 and VARIPULSE™ Catheter is pending CE mark..

在美国，VARIPULSE™ 导管和TRUPULSE™ 发电机目前正在研究中，未经监管机构批准。在欧洲，TRUPULSE™ 发电机在2023年末获得CE标志，VARIPULSE™ 导管正在等待CE标记。。

About Biosense WebsterBiosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical-technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care.

关于Biosense Webster Biosense Webster，Inc.是心律失常诊断和治疗背后科学技术的全球市场领导者。作为强生医疗技术公司的一部分，这家专业医疗技术公司的总部位于加利福尼亚州欧文市，在全球范围内致力于改进帮助电生理学家识别、治疗和提供护理的工具和解决方案。

Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter..

在biosensewebster.com上了解更多信息，并在LinkedIn和X（前身为Twitter）上进行连接。。

About Johnson & Johnson MedTechiiAt Johnson & Johnson MedTech,i we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health.

关于Johnson＆Johnson MedTechiiAt Johnson＆Johnson MedTech，我们释放出多样化的医疗保健专业知识，有目的的技术，以及对人们的热情，以改变医疗干预的未来，并赋予每个人尽可能过上最好的生活。一个多世纪以来，我们推动了突破性的科学创新，以解决未满足的需求并重新想象健康。

In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized..

在外科、骨科、视觉和介入解决方案领域，我们将继续帮助挽救生命，创造一个医疗保健解决方案更加智能、微创和个性化的未来。。

Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE™ Platform clinical trials. 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 Biosense Webster, Inc., and/or Johnson & Johnson.

关于前瞻性声明的注意事项本新闻稿包含1995年《私人证券诉讼改革法案》中关于VARIPULSE的“前瞻性声明”™ 平台临床试验。这些声明基于当前对未来事件的预期。如果基本假设证明不准确或出现已知或未知的风险或不确定性，实际结果可能与Biosense Webster，Inc.和/或Johnson＆Johnson的预期和预测有很大差异。

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：监管批准的不确定性；商业成功的不确定性；专利面临的挑战；竞争，包括竞争对手取得的技术进步、新产品和专利；导致产品召回或监管行动的产品功效或安全问题；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行为和消费模式的变化；以及医疗保健成本控制的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, 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.

有关这些风险、不确定性和其他因素的更多列表和描述，请参见强生公司截至2023年1月1日的10-K表年度报告，包括标题为“关于前瞻性声明的警示说明”和“项目1A”的章节。“风险因素”，以及强生公司随后在10-Q表上的季度报告以及向美国证券交易委员会提交的其他文件中。

Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. None of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments..

这些文件的副本可在sec.gov、jnj.com或强生公司的要求下在线获得。Biosense Webster，Inc.和强生公司均不承诺因新信息或未来事件或发展而更新任何前瞻性声明。。

© Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. US_BWI_THER_303927.1

©强生生物传感器韦伯斯特公司，2024年。保留所有权利。US\U BWI\U THER\U 303927.1

i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's MedTech segment.ii Primary adverse events were defined as myocardial infarction, thromboembolism, transient ischemic attack, diaphragmatic paralysis, pneumothorax, heart block, pulmonary edema, vagal nerve injury, pericarditis, major vascular access complication or bleeding, death, stroke, or any other cerebrovascular accident.

i强生医疗科技（Johnson＆Johnson MedTech）包括强生医疗科技（Johnson＆Johnson MedTech）部门内的外科、骨科、视力和介入解决方案业务。ii主要不良事件定义为心肌梗塞、血栓栓塞、短暂性脑缺血发作、膈肌麻痹、气胸、心脏传导阻滞、肺水肿、迷走神经损伤、心包炎，主要血管通路并发症或出血，死亡，中风或任何其他脑血管意外。

Atrioesophageal fistula and PV stenosis occurring >7 days post ablation along with cardiac tamponade or perforations occurring within 30 days of the ablation procedure were also considered primary adverse events.iii Nemocnice na Homolce entered into a clinical trial agreement with Johnson & Johnson Medical NV/SA for their participation in the inspIRE Study.

消融后>7天发生的食道瘘和PV狭窄以及消融后30天内发生的心脏压塞或穿孔也被认为是主要不良事件。iii Nemocnice na Homolce与Johnson＆Johnson Medical NV/SA签订了临床试验协议，以参与inspIRE研究。

Dr. Reddy served as a study coinvestigator. Dr. Reddy was compensated for consultancy purposes for his Multielectrode IRE Catheter Program Study Advisory Committee membership. Dr. Reddy was not compensated for this authorship contributions. iv Memorial HCA Savannah entered into a clinical trial agreement with Biosense Webster, Inc.

Reddy博士担任研究共同研究者。Reddy博士因其多电极IRE导管计划研究咨询委员会成员资格而获得咨询报酬。Reddy博士没有得到作者贡献的补偿。iv Memorial HCA Savannah与Biosense Webster，Inc.签订了临床试验协议。

for their participation in the admIRE Study. Dr. Newton served as a study coinvestigator. Dr. Newton serves as a consultant for BWI. Dr. Newton was not compensated for this authorship contributions..

感谢他们参与admIRE研究。牛顿博士是一位共同研究者。牛顿博士是BWI的顾问。牛顿博士的这一作者贡献没有得到补偿。。

1 Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston.2 Newton D, Natale A, Mansour M, Nair D, Senn T.  Pulsed Field Ablation Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study [abstract].

1 Reddy V，Grimaldi M，Duytschaever M，Anic A.使用具有3D映射集成的可变环导管进行脉冲场消融肺静脉隔离成功的预测因素：inspIRE的完整12个月结果[摘要]。在：AF研讨会上。；2月2-4日；波士顿。2 Newton D，Natale A，Mansour M，Nair D，Senn T。使用具有3D映射集成的可变环圆形导管进行脉冲场消融：admIRE研究的早期结果[摘要]。

In: AF Symposium.; February 2-4; Boston.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. Epub 2020 Jan 19. Erratum in: Int J Stroke. 2020 Jan 28;1747493020905964.

在：AF研讨会上。；2月2-4日；波士顿。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。Epub 2020年1月19日。勘误：Int J笔划。2020年1月28日；1747493020905964

PMID: 31955707.4 Kornej J, Börschel CS, Emelia J. Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. Circulation Research. 2020 June;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.3163405 Staerk, et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study.

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