May 10, 2024 – Medtronic today announced regulatory approval of its PulseSelect™ pulsed field ablation (PFA) system in Japan, broadening the global reach of the proven safe and effective technology for treatment of paroxysmal and persistent atrial fibrillation (AFib) patients. The approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on results from the pivotal PULSED AF trial, a global, multi-center IDE study, with centers in Japan, which evaluated the safety and effectiveness of PFA technology for AF ablation..

2024年5月10日–美敦力今天宣布其PulseSelect™脉冲场消融（PFA）系统在日本获得监管部门的批准，扩大了经证明安全有效的阵发性和持续性心房颤动（AFib）患者治疗技术的全球范围。日本厚生劳动省（MHLW）的批准是基于关键脉冲AF试验的结果，该试验是一项全球多中心IDE研究，与日本中心合作，评估了PFA技术用于AF消融的安全性和有效性。。

Since receiving CE Mark in Europe and the first-ever PFA approval by the U.S. Food and Drug Administration (FDA), cases have increased rapidly with more than 250 physicians globally successfully treating more than 3,000 patients with PulseSelect together with the company’s bi-directional 10F FlexCath Contour™ sheath..

自从在欧洲获得CE标志以及美国食品和药物管理局（FDA）首次批准PFA以来，病例迅速增加，全球250多名医生成功治疗了3000多名PulseSelect患者，并使用该公司的双向10F FlexCath Contour™护套。。

“We are seeing tremendous excitement and adoption of PulseSelect in every market we have launched, including the U.S., Europe and Canada. The positive feedback on safety profile, ease of handling, and its flexibility to be used with any mapping system has been consistent across many focal RF and single-shot shot users who have adopted it,” said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic.

美敦力心脏消融解决方案业务总裁丽贝卡·赛德尔（RebeccaSeidel）表示：“在我们推出的每个市场，包括美国、欧洲和加拿大，我们都看到了对PulseSelect的巨大兴奋和采用。在安全性、易操作性以及与任何映射系统一起使用的灵活性方面，积极的反馈在许多采用了它的聚焦射频和单次发射用户中都是一致的。”心脏消融解决方案业务是美敦力心血管产品组合的一部分。

“And now the expansion of PulseSelect into the important Japanese market is exciting for both physicians and for the patients they serve, who deserve the most advanced, safe, effective, and efficient care for AFib.”.

“现在，PulseSelect在日本重要市场的扩张对于医生和他们服务的患者来说都是令人兴奋的，他们应该为AFib提供最先进，安全，有效和高效的护理。”。

The PulseSelect PFA system was engineered with differentiated safety features and provides rapid, effective pulmonary vein isolation (PVI) through consistent and predictable energy delivery and catheter maneuverability. The system is designed to enable a seamless transition to PFA in a clinician's preferred workflow1. .

PulseSelect PFA系统具有不同的安全功能，并通过一致且可预测的能量输送和导管可操作性提供快速有效的肺静脉隔离（PVI）。该系统旨在实现临床医生首选工作流程中向PFA的无缝过渡1。

'The launch of the PulseSelect PFA catheter marks a new era in safety and an exciting shift in precision and efficiency in AFib treatment for my patients and those around the world,' said Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernard's Medical Center & Arrhythmia Research Group, Jonesboro, Arkansas.

阿肯色州琼斯伯勒圣伯纳德医学中心和心律失常研究小组心脏电生理学与研究主任Devi Nair医学博士说：“PulseSelect PFA导管的推出标志着一个安全的新时代，标志着AFib治疗对我的患者和全世界患者的精确度和效率的令人兴奋的转变。”。

'Designed for optimal safety and versatility, this catheter streamlines procedures with its intuitive workflow, empowering clinicians like me to deliver exceptional care efficiently.'.

“设计用于最佳安全性和多功能性，该导管通过其直观的工作流程简化了程序，使像我这样的临床医生能够有效地提供特殊护理。”。

Additionally, a new software upgrade is now available for PulseSelect, including an automated delivery mode which further simplifies the workflow and provides additional options for physicians to control pulsed field applications during the procedure. Upgrades have been completed across existing and new systems in Europe and Canada, are initiating in the U.S.

此外，PulseSelect现在可以进行新的软件升级，包括自动交付模式，该模式进一步简化了工作流程，并为医生在手术过程中控制脉冲场应用提供了额外的选项。欧洲和加拿大现有和新系统的升级已经完成，美国正在启动。

and will expand to countries including Japan upon approval..

并将在批准后扩展到包括日本在内的国家。。

“During development, our team designed the system to enable future software enhancements in the field. We are happy to report the first software update that automates the delivery of pulsed field energy and enhances the efficiency of the procedure. This update has been successfully installed in Western Europe and Canada and we have received FDA approval in the U.S.,” said Khaldoun Tarakji, M.D., MPH, vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “We will always be committed to innovation that meets physicians’ needs in order to provide the best care for patients globally.”.

“在开发过程中，我们的团队设计了该系统，以便在该领域实现未来的软件增强。我们很高兴报告第一次软件更新，该更新自动化了脉冲场能量的输送并提高了程序的效率。该更新已在西欧和加拿大成功安装，我们已在美国获得FDA批准，”美敦力心血管产品组合的心脏消融解决方案业务副总裁兼首席医疗官Khaldoun Tarakji医学博士说道。“我们将始终致力于创新，以满足医生的需求，为全球患者提供最佳护理。”。

PulseSelect received CE Mark in November 2023 and was approved in the United States in December 2023.

PulseSelect于2023年11月获得CE标志，并于2023年12月在美国获得批准。

About Atrial Fibrillation and Pulsed Field Ablation

关于心房颤动和脉冲场消融

AF is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide2. AF is a progressive disease, meaning it can become worse over time and can increase the risk of serious complications including heart failure, stroke and increased risk of death.3-6 Prior to PFA, ablation technologies relied on thermal effects to target cardiac tissue and risk damage to additional collateral structures in the heart.

房颤是最常见且治疗不足的心律失常之一，影响全球6000多万人2。房颤是一种进行性疾病，意味着它可能会随着时间的推移而恶化，并可能增加严重并发症的风险，包括心力衰竭，中风和死亡风险增加。3-6在PFA之前，消融技术依靠热效应靶向心脏组织，并有可能损害心脏其他侧支结构。

PFA uses pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of AF. Because the mechanism of cell death is non-thermal, the risk of collateral structure damage is potentially lower.  .

PFA使用脉冲电场有效隔离肺静脉以治疗房颤。由于细胞死亡的机制是非热的，因此侧支结构损伤的风险可能较低。。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 150 countries.

大胆思考。更大胆的行动。我们是美敦力。总部位于爱尔兰都柏林的美敦力公司是全球领先的医疗保健技术公司，通过寻找和寻找解决方案，大胆应对人类面临的最具挑战性的健康问题。我们的使命是减轻痛苦，恢复健康，延长寿命，我们团结了150个国家的95000多名充满激情的全球团队。

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。凭借我们丰富的知识、永不满足的好奇心以及帮助所有需要帮助的人的愿望，我们提供了创新技术，每秒钟、每小时、每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 (NYSE:MDT), visit www.Medtronic.com, and follow @Medtronic on LinkedIn..

随着我们增强洞察力驱动的护理、以人为本的体验以及为我们的世界带来更好的结果，对我们的期望会更高。在我们所做的每件事中，我们都在创造非凡。有关美敦力（纽约证券交易所：MDT）的更多信息，请访问www。Medtronic.com，并在LinkedIn上关注@Medtronic。。