New pacemakers offer 40% more battery life,1 extend Medtronic legacy of pacing leadership

新型起搏器的电池寿命延长了40%，1延续了美敦力在起搏领域的领先地位

DUBLIN, Jan. 5, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has received CE (Conformité Européenne) Mark for its Micra™ AV2 and Micra™ VR2, the next generation of its industry-leading miniature, leadless pacemakers.

都柏林，2024年1月5日/PRNewswire/--医疗保健技术的全球领导者美敦力公司（纽约证券交易所：MDT）今天宣布，其Micra已获得CE（ConformitéEuroperéenne）标志™ AV2和Micra™ VR2是业界领先的微型无铅起搏器的下一代产品。

Micra AV2 and Micra VR2, the world's smallest pacemakers, provide longer battery life and easier programming than prior Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.2

世界上最小的起搏器Micra AV2和Micra VR2比以前的Micra起搏器提供更长的电池寿命和更容易的编程，同时与传统起搏器相比，仍然具有无铅起搏的许多优点，例如减少并发症。2

With approximately 40% more battery life compared to previous generations,1 Medtronic projects the battery life of Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively.3 This means more than 80% of patients who receive a Micra may only require one device for life.3

与前几代相比，电池寿命增加了约40%，美敦力预计Micra AV2和Micra VR2的电池寿命分别接近16年和17年。3这意味着超过80%的接受Micra的患者可能一生只需要一个设备。3

This CE Mark milestone follows U.S. Food and Drug Administration approval for the Micra AV2 and VR2 devices in 2023.

这一CE标志里程碑是在美国食品和药物管理局于2023年批准Micra AV2和VR2设备之后取得的。

In addition to size and longevity benefits, Micra devices are also the only leadless pacemakers with remote monitoring capabilities, which allow a doctor or clinic to check on a patient's heart device without the need for a patient to travel to their clinic for an in-person appointment.  Other patient benefits of remote monitoring may include a reduction in hospitalizations and increase in sense of security.4,5.

除了尺寸和寿命的好处外，Micra设备也是唯一具有远程监测功能的无铅起搏器，它允许医生或诊所检查患者的心脏设备，而无需患者亲自前往诊所预约。远程监测的其他患者益处可能包括减少住院率和增加安全感。

'For more than eight years, our Micra leadless pacemakers have provided meaningful benefits to people in Europe who require a pacemaker. Now, these patients have access to the latest leadless pacing technology that, for most of them, may be the only device they will ever need,' said Robert C. Kowal, M.D., Ph.D., general manager, Cardiac Pacing Therapies within the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic..

“八年多来，我们的Micra无铅起搏器为欧洲需要起搏器的人提供了有意义的好处。“现在，这些患者可以使用最新的无铅起搏技术，对于大多数患者来说，这可能是他们唯一需要的设备，”医学博士罗伯特·科瓦尔（RobertC.Kowal）说，他是心律管理业务的心脏起搏治疗总经理，这是美敦力心血管投资组合的一部分。。

'The first generation of leadless Micra pacemakers demonstrated a significant reduction in major complications, and this next generation of Micra brings several additional benefits including greater longevity, and specifically for the Micra AV2, new algorithms to optimize AV synchrony at faster heart rates while requiring less in-office programming,' said Prof.

“第一代无铅Micra起搏器显示出主要并发症的显着减少，下一代Micra带来了一些额外的好处，包括更长的寿命，特别是对于Micra AV2，新算法可以在更快的心率下优化AV同步，同时需要更少的办公室编程，”教授说。

Dr. Christophe Garweg, Cardiologist at University Hospitals of Leuven, Belgium. 'These advantages likely will expand the use of the leadless pacemaker to more patients.'.

比利时鲁汶大学医院心脏病专家克里斯托夫·加威格博士说这些优点可能会将无铅起搏器的使用扩展到更多患者。”。

Globally, more than 200,000 patients have received Micra pacemakers.6 Comparable in size to a large vitamin, Micra pacemakers are less than one-tenth the size of traditional pacemakers. Unlike traditional pacemakers, Micra pacemakers do not require leads or a surgical 'pocket' under the skin, so potential sources of complications related to leads and pockets are eliminated, and there is no visible sign of the device..

在全球范围内，超过200000名患者接受了Micra起搏器。6与大量维生素相当，Micra起搏器的大小不到传统起搏器的十分之一。与传统起搏器不同，Micra起搏器不需要导线或皮肤下的手术“口袋”，因此消除了与导线和口袋相关的潜在并发症来源，并且没有明显的设备迹象。。

Leaders in Cardiac PacingReceiving CE Mark for Micra AV2 and VR2 builds on the Medtronic legacy in cardiac pacing, which includes:

心脏起搏领域的领导者接受Micra AV2和VR2的CE标志是基于美敦力在心脏起搏领域的传统，其中包括：

Inventing the first wearable pacemaker in 1957.

1957年发明了第一个可穿戴式起搏器。

Launching the first pacemaker for use in MRIs in 2011.

2011年推出第一个用于MRI的起搏器。

Creating and launching the first leadless pacemaker in 2015.

2015年创建并推出首款无铅起搏器。

Launching the first leadless pacemaker to coordinate the heart's electrical signals by sensing atrial activity, without a lead or device in the atria, in 2020.

2020年，在心房没有导线或装置的情况下，推出了第一个通过感知心房活动来协调心脏电信号的无铅起搏器。

Gaining regulatory approval for the first pacing system to activate the heart's natural electrical system, conduction system pacing (approval via the His-bundle in 2018 and via the left bundle branch area in 2022).

获得监管部门对第一个起搏系统的批准，以激活心脏的自然电系统，传导系统起搏（2018年通过His束批准，2022年通过左束支区域批准）。

Receiving U.S. approval for Micra AV2 and VR2 in 2023.

2023年获得美国对Micra AV2和VR2的批准。

About MedtronicBold 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 90,000+ passionate people across more than 150 countries.

关于美敦力思维。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（Medtronic plc）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，我们将150多个国家的90000多名充满激情的全球团队团结在一起。

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 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。有关美敦力的更多信息，请访问www.Medtronic.com和LinkedIn。。

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.

任何前瞻性声明都会受到风险和不确定性的影响，例如美敦力向美国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存在重大差异。

References:

参考文献：

1 Escalante K. Micra AV2 and Micra VR2 longevity comparison. 2023. Medtronic Data on File.

1 Escalante K.Micra AV2和Micra VR2寿命比较。美敦力数据存档。

2 El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. December 2018;15(12):1800-1807.

2 El Chami MF，Al Samadi F，Clementy N等人。Micra经导管起搏器在现实环境中的最新性能：与研究研究和经静脉历史对照的比较。心律。2018年12月；15（12）：1800-1807年。

3 Sheldon T, Escalante K, and Fagan D. Device Longevity and AV Synchrony Algorithm Modeling of a Leadless Pacemaker Family: A Virtual Patient Analysis. January 2023. Medtronic Data on File.

3 Sheldon T，Escalante K和Fagan D.无铅起搏器家族的设备寿命和AV同步算法建模：虚拟患者分析。2023年1月。美敦力数据存档。

4 Piccini JP, Mittal S, Snell J, Prillinger JB, Dalal N, Varma N. Impact of remote monitoring on clinical events and associated health care utilization: A nationwide assessment. Heart Rhythm. 2016 Dec;13(12):2279-2286. doi: 10.1016/j.hrthm.2016.08.024. Epub 2016 Aug 17. PMID: 27544748.

4 Piccini JP，Mittal S，Snell J，Prillinger JB，Dalal N，Varma N.远程监测对临床事件和相关医疗保健利用的影响：全国评估。心律。2016年12月；13（12）：2279-2286。doi:10.1016/j.hrthm.2016.08.024。Epub 2016年8月17日。PMID:27544748。

5 Artico J, Zecchin M, Fantasia AZ, Skerl G, Ortis B, Franco S, Albani S, Barbati G, Cristallini J, Sinagra G. Long-term patient satisfaction with implanted device remote monitoring: a comparison among different systems. Journal of Cardiovascular Medicine. 2019 Aug 1;20(8):542-50.

5 Artico J，Zecchin M，Fantasia AZ，Skerl G，Ortis B，Franco S，Albani S，Barbati G，Cristallini J，Sinagra G.植入设备远程监测的长期患者满意度：不同系统之间的比较。心血管医学杂志。2019年8月1日；20（8）：542-50。

6 Leick, A. Micra 'Largest Reach' supporting data. September 2023. Medtronic Data on file.

6 Leick，A。Micra“最大范围”支持数据。2023年9月。美敦力数据存档。

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来源美敦力plc