Medtronic, a global leader in healthcare technology, today announced that Aarhus University Hospital has completed its first cardiac ablation procedure using the Affera™ Mapping and Ablation System, including the Sphere-9™ Catheter and the Affera™ Prism-1 Mapping Software. This marks the first commercial usage of the system in Denmark.

美敦力（Medtronic），全球医疗技术的领导者，今天宣布奥胡斯大学医院使用Affera™标测与消融系统（包括Sphere-9™导管和Affera™ Prism-1标测软件）完成了其首例心脏消融手术。这标志着该系统在丹麦的首次商业应用。

The Affera system is designed to map, ablate and validate atrial arrhythmias (fast, abnormal heart rhythms) and provides real-time feedback through intuitive mapping and navigation software. This introduction at Aarhus University Hospital represents an important advancement for cardiac ablation in Denmark..

Affera系统旨在绘制、消融和验证心房心律失常（快速、异常的心律），并通过直观的映射和导航软件提供实时反馈。该系统在奥胡斯大学医院的引入代表了丹麦心脏消融技术的重要进步。

Supported by results from clinical studies assessing the safety and performance of the Sphere-9™ Catheter, the Affera™ Mapping and Ablation System received CE Mark in March 2023. In April 2023, 12-month findings from the EU clinical study supporting the CE Mark were published in

基于评估Sphere-9™导管安全性和性能的临床研究结果，Affera™标测与消融系统于2023年3月获得CE认证。2023年4月，支持CE认证的欧盟临床研究的12个月研究结果发布在

JACC: Clinical Electrophysiology

JACC：临床电生理学

, demonstrating that the Sphere-9™ Catheter can successfully treat patients with either paroxysmal or persistent atrial fibrillation (AF) in an efficient, safe, and clinically effective manner.

，证明了Sphere-9™导管可以成功治疗阵发性或持续性心房颤动（AF）患者，且具有高效、安全和临床有效的特点。

The first patient treated with the Affera™ system in Denmark was cared for by the electrophysiology team at Aarhus University Hospital, led by

丹麦首位接受Affera™系统治疗的患者由奥胡斯大学医院的心脏电生理团队照料，该团队由

Steen Buus Kristiansen, Head of Arrhythmia, Department of Cardiology

斯蒂恩·布斯·克里斯蒂安森，心律失常科负责人，心脏病学科

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“For patients, this means we can offer a more individualized and tailored catheter-based treatment for atrial fibrillation, with an expected good and lasting outcome. In addition, we expect to optimize workflows during procedures with this new technology, allowing us to offer even more patients an effective catheter treatment for their atrial fibrillation..

“对于患者而言，这意味着我们可以提供更具个性化和针对性的基于导管的心房颤动治疗，并预期获得良好且持久的效果。此外，我们预计这项新技术将优化手术过程中的工作流程，使我们能够为更多患者提供有效的导管治疗来应对他们的心房颤动。”

We are constantly working to maintain and strengthen our national and international position within treatment, clinical development, and research in cardiac arrhythmias. That is why we are pleased that we are the first in Denmark to offer our patients treatment with this new technology” - Steen Buus Kristiansen, Chief Physician at Heart Diseases, Aarhus University Hospital..

我们正在不懈努力，保持并加强我们在心脏心律失常治疗、临床开发和研究方面的国内和国际地位。因此，我们很高兴成为丹麦首家为患者提供这项新技术治疗的医院。”——奥胡斯大学医院心脏病科首席医师斯特恩·布斯·克里斯蒂安森。

Atrial fibrillation affects more than 60 million people worldwide.

房颤影响着全世界超过6000万人。

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Persistent AF occurs when symptoms last for more than seven days and do not resolve without intervention, while paroxysmal AF episodes last from seconds to days but stop spontaneously. Without early or timely intervention, AF can progress

持续性房颤是指症状持续超过七天且不经干预不会缓解，而阵发性房颤发作可持续数秒至数天，但会自行停止。如果不进行早期或及时干预，房颤可能会进展。

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and is associated with higher rates of cardiovascular admissions

并且与较高的心血管疾病入院率相关

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3

, heart failure hospitalization

，心力衰竭住院治疗

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4

, mortality

，死亡率

5

5

, and reduced quality of life

，并降低生活质量

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. Treatment options include medication, cardioversion, or catheter ablation.

治疗选项包括药物、心脏复律或导管消融。

In clinical studies, treatment with the Sphere-9™ Catheter using the optimized PULSE³ waveform (the commercial Affera System pulsed field waveform) achieved

在临床研究中，使用优化的PULSE³波形（商业Affera系统脉冲场波形）进行Sphere-9™导管治疗实现了

85% one-year freedom from recurrence of atrial arrhythmias in persistent AF patients

持续性房颤患者一年内无心律失常复发率为85%

. Across all paroxysmal and persistent AF patients who underwent an ablation and all PFA waveforms tested,

在所有接受消融治疗的阵发性和持续性房颤患者以及所有测试的PFA波形中，

78% remained free from all atrial arrhythmias

78%的患者未出现任何心房心律失常。

at the conclusion of the study. The system achieved a

在研究结束时，系统达到了一个

primary safety endpoint of 0.6%

主要安全终点为0.6%

, with zero cases of atrio-esophageal fistula, coronary spasm, pulmonary vein stenosis, or phrenic nerve injury.

，心房食管瘘、冠状动脉痉挛、肺静脉狭窄或膈神经损伤的病例为零。

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For more information about the Medtronic Affera Mapping and Ablation System and available treatment options, visit

有关美敦力Affera标测与消融系统及可用治疗选项的更多信息，请访问

Medtronic.eu

美敦力.eu

.

。

References:

参考文献：

Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.

Roth GA, Mensah GA, Johnson CO 等。1990-2019年全球心血管疾病和风险因素负担：GBD 2019研究更新。《美国心脏病学会杂志》2020;76:2982-3021。

Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.

宫坂义明，巴恩斯ME，贝利KR，等。首次诊断为心房颤动患者的死亡率趋势：一项为期21年的社区研究。《美国心脏病学会杂志》2007；49：986-92。

Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.

Hindricks G, Potpara T, Dagres N, 等。2020年欧洲心脏病学会（ESC）与欧洲心胸外科协会（EACTS）合作制定的房颤诊断和管理指南。《欧洲心脏杂志》，2020年。

Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.

Wolf PA，Abbott RD，Kannel WB。心房颤动作为卒中的独立风险因素：弗雷明翰研究。《卒中》1991；22：983-8。

Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126.

Lubitz SA、Moser C、Sullivan L 等。社区中房颤模式与随后中风、心力衰竭或死亡的风险。《美国心脏协会杂志》2013；2：e000126。

Anter E, Mansour M, Nair DG, et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nature Medicine. 2024; 30: 2303–2310.

Anter E, Mansour M, Nair DG, 等。双能量晶格尖端消融系统治疗持续性心房颤动：一项随机试验。《自然医学》。2024年；30卷：2303-2310页。

Affera EU Clinical Study. Twelve-month results supporting CE Mark approval for the Affera™ Mapping and Ablation System [TT1]. JACC: Electrophysiology. April 2023.

Affera 欧盟临床研究。支持 Affera™ 标测与消融系统获得 CE 标志批准的十二个月结果 [TT1]。《JACC：电生理学》。2023年4月。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

大胆思考。更大胆的行动。我们是美敦力。美敦力公司总部位于爱尔兰戈尔韦，是全球领先的医疗技术公司，通过寻找并发现解决方案，勇敢地应对人类面临的最严峻的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们多样化的知识、永无止境的好奇心和帮助所有需要帮助的人的愿望，我们提供了创新的技术，每秒、每小时、每一天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit .

期待我们做得更多，因为我们致力于推动以洞察力为基础的护理、以人为本的体验，以及为我们的世界带来更好的结果。在我们所做的每一件事中，我们都在创造非凡。欲了解有关美敦力的更多信息，请访问。

Medtronic.eu

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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

任何前瞻性陈述均受风险和不确定性的影响，例如美敦力向证券交易委员会提交的定期报告中所述的风险和不确定性。实际结果可能与预期结果有重大差异。

Contacts:

联系人：

Sofia Bjärno

索菲亚·比约恩

Public Relations

公共关系

Sofia.bjarno@medtronic.com

索菲亚·比约诺@美敦力.com

Ryan Weispfenning

瑞安·魏斯芬宁

Investor Relations

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