First-of-its-kind Aurora EV-ICD™ system offers single device, single procedure with lead placed outside of heart and veinsDUBLIN, Oct. 23, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA).

首创的Aurora EV-ICD™ system提供单一设备，单一程序，引线置于心脏和veinsDUBLIN之外，2023年10月23日/PRNewswire/-Medtronic plc（NYSE:MDT）是医疗保健技术的全球领导者，已获得美国食品和药物管理局（FDA）对Aurora EV-ICD的批准™ MRI SureScan™ （血管外植入式心律转复除颤器）和Epsila EV™ MRI SureScan™ 除颤导致治疗危险的快速心律，可导致心脏骤停（SCA）。

The Aurora EV-ICD system is the first-of-its-kind to provide the life-saving benefits of traditional, transvenous ICDs with a lead (thin wire) placed under the breastbone, outside of the heart and veins. The Aurora EV-ICD delivers lifesaving defibrillation, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies via a device similar in size, shape, and longevity to traditional, transvenous ICDs..

Aurora EV-ICD系统是同类产品中的第一个，提供传统经静脉ICD的救生益处，其中铅（细线）放置在胸骨下，心脏和静脉外。Aurora EV-ICD通过与传统经静脉ICD尺寸，形状和寿命相似的设备，提供救生除颤，抗心动过速起搏（ATP）和备用（暂停预防）起搏治疗。。

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Medtronic Aurora EV-ICD™ system animation

美敦力极光EV-ICD™ 系统动画

Medtronic Aurora EV-ICD™ system

美敦力极光EV-ICD™ 系统

Medtronic Aurora EV-ICD™ system

美敦力极光EV-ICD™ 系统

FDA approval of the Medtronic Aurora EV-ICD system includes the system's proprietary procedure implant tools, and was supported by global pivotal trial results showing the system's safety and effectiveness, which were published in The New England Journal of Medicine. In the coming weeks, the Aurora EV-ICD system will be commercially available on a limited basis in the United States..

FDA批准Medtronic Aurora EV-ICD系统包括该系统专有的程序植入工具，并得到全球关键试验结果的支持，该结果显示该系统的安全性和有效性，该结果发表在新英格兰医学杂志上。在未来几周内，Aurora EV-ICD系统将在美国有限的基础上商业化。。

'The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology,' said Bradley P. Knight, M.D., medical director of Electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute and a co-author of the study. 'Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications, ultimately allowing us to further evolve safe and effective ICD technology.'  .

西北医学布鲁姆心血管研究所电生理医学主任兼该研究的共同作者布拉德利·P·奈特博士说：“Aurora EV-ICD系统是植入式除颤器技术向前迈出的巨大一步。”将导线置于心脏外部，而不是心脏和静脉内部，可降低长期并发症的风险，最终使我们能够进一步发展安全有效的ICD技术 .

In the pivotal study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7%, and there we no major intraprocedural complications, nor any unique complications observed related to the EV ICD procedure or system compared to transvenous and subcutaneous ICDs.[1] Additionally, 33 defibrillation shocks were avoided1 by having ATP – which paces the heart to interrupt and terminate a dangerous rhythm – programmed 'on.' And at six months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death.1ICDs are highly effective in providing life-saving therapy for patients at risk of SCA, an electrical problem with the heart due to a dangerously fast heart rate (ventricular tachycardia) or irregular rhythm (ventricular fibrillation).

在这项关键性研究中，该装置在植入物除颤治疗方面的有效性为98.7%，与经静脉和皮下ICD相比，我们没有发生重大的术中并发症，也没有观察到与EV ICD手术或系统相关的任何独特并发症。[1] 此外，通过使用ATP可以避免33次除颤电击1，ATP可以使心脏起搏以中断并终止危险的节律，并进行“开启”在六个月时，92.6%的患者（Kaplan-Meier估计）没有出现主要的系统和/或程序相关的主要并发症，如住院，系统修订或死亡.1CDS在为患者提供救生治疗方面非常有效有SCA风险，由于危险的快速心率（室性心动过速）或不规则的节律（心室颤动）引起的心脏电问题。

If not treated immediately, SCA is often fatal (termed sudden cardiac death). Traditional ICDs typically are implanted below the collarbone, with the lead(s) threaded through the veins and into the heart.'This FDA approval paves the way for patients to have a better overall experience with ICD therapy,' said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. 'ICDs remain the gold standard for prevention of sudden cardiac death, and while the subcutaneous ICD avoids certain complications associated with transvenous defibrillators, it has limitations that may affect a patient's comfort and quality-of-life.

如果不立即治疗，SCA通常是致命的（称为心源性猝死）。传统的ICD通常植入锁骨下方，导线穿过静脉并进入心脏美国食品和药物管理局的批准为患者在ICD治疗方面获得更好的整体经验铺平了道路，“心律管理业务首席医疗官Alan Cheng博士说，该业务是美敦力心血管产品组合的一部分。ICD仍然是预防心源性猝死的金标准，虽然皮下ICD避免了与经静脉除颤器相关的某些并发症，但其局限性可能会影响患者的舒适度和生活质量。

With the Aurora EV-ICD system, patients can benefit from the only ICD placed outside the vascular space that provides ATP and back-up pacing, in a device that is nearly half the size and with 60% greater projected battery longe.

使用Aurora EV-ICD系统，患者可以受益于放置在血管空间之外的唯一ICD，该ICD提供ATP和备用起搏，该设备的尺寸几乎是其一半，预计电池长度增加60%。

Anti-tachycardia Pacing (ATP), to terminate ventricular arrhythmias (rapid and/or chaotic activity of the heart that can lead to SCA) using low-energy pacing pulses, potentially avoiding a defibrillation shock.

抗心动过速起搏（ATP），使用低能量起搏脉冲终止室性心律失常（心脏的快速和/或混乱活动，可导致SCA），可能避免除颤休克。

Pause Prevention Pacing, to provide back-up pacing for brief, intermittent, heartbeat pauses.

暂停预防起搏，为短暂，间歇的心跳暂停提供备用起搏。

40 Joule Defibrillation Energy, to deliver life-saving shocks in a device the size of transvenous ICDs (33 cc)

40焦耳除颤能量，在经静脉ICD（33 cc）大小的设备中提供挽救生命的电击

Medtronic exclusive PhysioCurve™ design, to increase patient comfort and implant acceptance.

美敦力独家生理曲线™ 设计，以提高患者的舒适度和植入物的接受度。

11.7-year projected longevity, to reduce device replacement procedures during a patient's lifetime.

预计寿命为11.7年，以减少患者一生中的设备更换程序。

Patients who receive the commercially available Aurora device also will benefit from the addition of Smart Sense, a proprietary algorithm designed to reduce the potential for inappropriate shocks.Medtronic will obtain real-world performance and safety data on the Aurora system in the Enlighten global post-approval registry, a prospective, non-randomized, observational, multicenter study, expected to last five years and enroll approximately 1,000 patients.

接受商用Aurora设备的患者也将受益于Smart Sense的增加，Smart Sense是一种专有算法，旨在减少不适当电击的可能性。美敦力将通过Enlighten全球批准后登记处获得Aurora系统的实际性能和安全性数据，这是一项前瞻性，非随机，观察性，多中心研究，预计将持续五年并招募约1000名患者。

First implants in Enlighten and first commercial implants worldwide were recently conducted by Lucas V.A. Boersma, M.D., Ph.D., cardiologist at St. Antonius Hospital, Nieuwegein, The Netherlands, and a limited launch is underway in select European countries.The Aurora EV-ICD system is indicated for patients who are at risk of life-threatening arrhythmias, and who have not had a prior sternotomy and do not need chronic bradycardia (abnormally slow heartbeat) pacing.About the EV ICD Pivotal StudyThe EV ICD Pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death.

最近由荷兰Nieuwegein的St.Antonius医院的Lucas V.A.Boersma，M.D.，Ph.D.的心脏病专家Lucas V.A.Boersma进行了Eminesity和全球第一批商业植入物的首次植入，并且在一些欧洲国家正在进行有限的发射。Aurora EV-ICD系统适用于有危及生命的心律失常风险，既往没有胸骨切开术且不需要慢性心动过缓（心跳异常缓慢）起搏的患者。关于EV ICD关键研究EV ICD关键研究是一项前瞻性，多中心，单臂，非随机，上市前临床研究，评估美敦力EV ICD系统对有心脏猝死风险的患者的安全性和有效性。

It enrolled 356 patients at 46 sites in 17 countries in North America, Europe, the Middle East, Asia, Australia and New Zealand, and results were published in The New England Journal of Medicine. Safety and effectiveness results were sustained out to 18 months.2  About MedtronicBold thinking. Bolder actions.

它在北美，欧洲，中东，亚洲，澳大利亚和新西兰的17个国家的46个地点招收了356名患者，结果发表在“新英格兰医学杂志”上。安全性和有效性结果持续至18个月.2关于美敦力BOLD思维。更大胆的行动。

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 — un.

我们是美敦力公司。美敦力有限公司总部设在爱尔兰都柏林，是领先的全球医疗保健技术公司，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-减轻疼痛，恢复健康，延长生命。

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______________________________________________1Friedman P, Murgatroyd F, Boersma LVA, et al. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator. N Engl J Med 2022; 387:1292-1302.2Friedman P, Murgatroyd F, Boersma LVA, et al. Chronic Safety and Performance of the Extravascular ICD: Results from the Global EV ICD Pivotal Study.

______________________________________________1Friedman P，Murgatroyd F，Boersma LVA等人。血管外植入式心脏复律除颤器的功效和安全性。英格兰医学杂志2022；387:1292-1302.2Friedman P，Murgatroyd F，Boersma LVA等人。血管外ICD的慢性安全性和表现：全球EV ICD关键研究的结果。

Heart Rhythm Society late breaking clinical trials, May 20, 2023.SOURCE Medtronic plc.

心律协会晚破临床试验，2023年5月20日。来源美敦力公司。