Symplicity blood pressure procedure is now covered for qualifying Medicare patients

Symplicity 血压手术现在已对符合条件的 Medicare 患者提供保障。

GALWAY,

戈尔韦，

Ireland

爱尔兰

,

，

Oct. 28, 2025

2025年10月28日

/

/

PRNewswire

美通社

/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the Centers for Medicare & Medicaid Services (CMS) has released the final National Coverage Determination (NCD) on renal denervation, applicable to the Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity blood pressure procedure.

/ -- 全球医疗技术领导者美敦力公司（纽约证券交易所代码：MDT）今天宣布，美国医疗保险和医疗补助服务中心（CMS）已发布关于肾去神经术的最终全国覆盖决定（NCD），适用于Symplicity Spyral™肾去神经术（RDN）系统，也称为Symplicity血压手术。

This final determination will now provide Medicare patients with access to the Symplicity blood pressure procedure for the treatment of uncontrolled hypertension, or high blood pressure. .

这一最终决定将使医疗保险患者能够接受Symplicity血压手术以治疗失控的高血压或血压升高。

'We are very pleased with the final national coverage determination, which opens up patient access to renal denervation with the Symplicity Spyral RDN system, a safe and durable blood pressure-lowering procedure for patients who have not succeeded with medication or lifestyle changes alone,' said

“我们对最终的全国覆盖决定感到非常满意，这为肾去神经术使用Symplicity Spyral RDN系统开放了患者获取通道，这是一种对于仅靠药物或生活方式改变未能成功的患者而言安全且持久的降血压手术，”

Jason Weidman

杰森·魏德曼

, senior vice president and president of the Coronary & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. 'This milestone enables physicians to offer patients more choices when managing hypertension, potentially leading to better outcomes for a population in urgent need of new options.

，冠状动脉及肾去神经业务的高级副总裁兼总裁，该业务隶属于美敦力的心血管产品组合。 “这一里程碑使医生在管理高血压时能够为患者提供更多的选择，有望为迫切需要新方案的人群带来更好的治疗结果。

We congratulate CMS and recognize all the work it took to get to this point.'.

我们祝贺CMS，并认可它为达到这一目标所付出的所有努力。

The Symplicity Spyral RDN system, approved by the U.S. Food and Drug Administration (FDA) in November 2023, is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney.

2023年11月，美敦力的Symplicity Spyral RDN系统获得美国食品和药物管理局（FDA）批准，这是一种创新的微创手术，通过向肾附近可能变得过度活跃并导致高血压的神经传递射频能量。在镇静后，医生会将一根细管（称为导管）插入通往肾脏的动脉。

Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.  .

一旦导管就位，医生就会向系统施加能量，以抑制与肾脏相连的神经的过度活动。之后导管会被移除，体内不会留下任何植入物。

'We're proud to be at the forefront of expanding access to minimally invasive therapies and advancing hypertension treatment,' said

“我们很自豪能够站在扩大微创治疗的可及性和推进高血压治疗的前沿，”

Skip Kiil

跳过 Kiil

, executive vice president and president of the Medtronic Cardiovascular portfolio. 'This determination represents a significant opportunity to improve care for patients and opens a novel and meaningful market for Medtronic, positioning our renal denervation technology as one of the most exciting growth drivers for the company.

执行副总裁兼美敦力心血管产品组合总裁。“这一决定代表着改善患者护理的重大机会，为美敦力开辟了一个新颖且有意义的市场，使我们的肾去神经技术成为公司最令人兴奋的增长动力之一。

Our commercial teams will be actively leveraging this milestone, collaborating closely with healthcare providers and hypertension centers as we accelerate the adoption of this transformative growth opportunity for Medtronic.'.

我们的商业团队将积极利用这一里程碑，与医疗保健提供者和高血压中心密切合作，加速推动这一对美敦力而言具有变革性意义的增长机会的采用。

Symplicity Spyral is available in major centers across the U.S., including large integrated delivery networks as part of their hypertension care offerings.

Symplicity Spyral已在美国各大中心提供，包括作为其高血压护理服务的一部分的大型综合交付网络。

Medtronic will continue working with physician partners and healthcare providers as they adopt the technology to support patient access.

美敦力将继续与医生伙伴和医疗保健提供者合作，因为他们采用该技术来支持患者获取。

The Symplicity Spyral RDN system is approved for commercial use in nearly 80 countries around the world.

Symplicity Spyral RDN系统已在近80个国家获准商业使用。

About Hypertension

关于高血压

Hypertension, or high blood pressure, is a global health crisis, and is the leading modifiable cause of heart attack, stroke, and death.

高血压，即血压升高，是全球健康危机，也是心脏病发作、中风和死亡的首要可改变原因。

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Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly 80% of adults with hypertension do not have it under control

尽管有药物和生活方式改变的治疗，许多患者的血压仍然无法控制。近80%的高血压成年人没有将其控制住。

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and 50% of hypertension patients become non-adherent to medication within one year.

50%的高血压患者在一年内停止服药。

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About the SPYRAL HTN Global Clinical Program

关于SPYRAL HTN全球临床项目

The Medtronic SPYRAL HTN global clinical program is the most comprehensive clinical program studying RDN in more than 5,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk, and is backed by experience in over 30,000 patients globally.

美敦力SPYRAL HTN全球临床项目是研究RDN最全面的临床项目，在超过5000名患者中进行研究，无论是否用药，且这些患者具有较高的基线心血管风险，并拥有全球超过30000例患者的经验支持。

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The Symplicity Spyral RDN system has demonstrated sustained and durable drops in blood pressure out to three years in randomized control and real-world registry trials.

Symplicity Spyral RDN系统在随机对照试验和真实世界注册试验中，已证明在三年内持续且显著地降低了血压。

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Symplicity Spyral is the only commercially available RDN device with the breadth of durable, consistent, long-term data and single catheter design.

Symplicity Spyral 是唯一一款具有广泛、持久、一致的长期数据和单导管设计的商用 RDN 设备。

4, 5, 8, 10, 14

4、5、8、10、14

About Medtronic

美敦力公司简介

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,

大胆思考。更大胆的行动。我们是美敦力。美敦力公司，总部位于戈尔韦，

Ireland

爱尔兰

, 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.

是全球领先的医疗技术公司，大胆攻克人类面临的最棘手的健康问题，通过不断寻找并发现解决方案。我们的使命——减轻痛苦、恢复健康、延长生命——团结了遍布150多个国家的95,000多名充满热情的员工。

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 (NYSE: MDT), visit .

随着我们推动以洞察力为导向的护理、以人为本的体验以及为我们的世界带来更好的结果，期待我们做得更多。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（纽约证券交易所代码：MDT）的更多信息，请访问。

www.Medtronic.com

www.美敦力.com

and follow Medtronic on

并关注美敦力

LinkedIn

领英

.

。

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，例如美敦力公司向证券交易委员会提交的定期报告中描述的那些。实际结果可能与预期结果有重大差异。

Contacts:

联系人：

Krystin Hayward Leong

克莉丝汀·海沃德·梁

Public Relations

公共关系

+1-508 -298-8246

+1-508-298-8246

Ryan Weispfenning

瑞安·魏斯芬宁

Investor Relations

投资者关系

+1-763-505-4626

+1-763-505-4626

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WHO. Hypertension fact sheet. September 25, 2025. Available at:

世界卫生组织。高血压事实表。2025年9月25日。可于以下网址获取：

https://www.who.int/news-room/fact-sheets/detail/hypertension

https://www.who.int/zh/news-room/fact-sheets/detail/hypertension

.

。

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Berra E, Azizi M, Capron A, et al. A. Evaluation of Adherence Should Become an Integral Part of Assessment of Patients With Apparently Treatment-Resistant Hypertension. Hypertension. 2016 Aug;68(2):297-306.

贝拉·E、阿齐兹·M、卡普龙·A 等。评估依从性应成为表观治疗耐药性高血压患者评估的组成部分。《高血压》。2016年8月；68(2):297-306。

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Medtronic data on file, RDN Catheter Historical Data,

美敦力公司存档数据，RDN 导管历史数据，

Feb 2025

2025年2月

. Data includes both Symplicity Flex and Symplicity Spyral.

数据包括Symplicity Flex和Symplicity Spyral。

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Kandzari DE, Townsend RR, Kario K, et al. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. 2023

Kandzari DE, Townsend RR, Kario K, 等。肾去神经术在服用抗高血压药物患者中的安全性和有效性。《美国心脏病学会杂志》。2023年。

Nov 7

11月7日

;82(19):1809-1823.

；82（19）：1809-1823。

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Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020

Böhm M, Kario K, Kandzari DE, 等。在无抗高血压药物的情况下导管肾去神经术的疗效（SPYRAL HTN-OFF MED 关键试验）：一项多中心、随机、假手术对照试验。《柳叶刀》。2020年。

May 2

5月2日

;395(10234):1444-1451.

;395(10234):1444-1451.

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Kario K, Ogawa H, Okumura K, et al. SYMPLICITY HTN-Japan - first randomized controlled trial of catheter-based renal denervation in asian patients -. Circ J. 2015;79(6):1222–1229.

Kario K, Ogawa H, Okumura K, 等。SYMPLICITY HTN-Japan - 亚洲患者中首个基于导管的肾去神经术随机对照试验。《循环杂志》。2015;79(6):1222–1229。

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Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial renal denervation for resistant hypertension. N Engl J Med.

Bhatt DL, Kandzari DE, O'Neill WW, 等。肾去神经术治疗顽固性高血压的对照试验。新英格兰医学杂志。

April 10, 2014

2014年4月10日

;370(15):1393–1401.

；370（15）：1393–1401。

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Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFFMED): a randomised, sham-controlled, proof-of-concept trial. Lancet.

Townsend RR, Mahfoud F, Kandzari DE, 等。在未使用抗高血压药物的情况下，对未控制高血压患者进行基于导管的肾去神经术（SPYRAL HTN-OFFMED）：一项随机、假手术对照、概念验证试验。《柳叶刀》。

November 11, 2017

2017年11月11日

;390(10108):2160–2170.

;390(10108):2160–2170.

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Krum H, Schlaich MP, Sobotka PA, et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014;383(9917):622–629.

Krum H, Schlaich MP, Sobotka PA, 等。经皮肾去神经术治疗顽固性高血压患者：Symplicity HTN-1研究最终3年报告。《柳叶刀》。2014;383(9917):622–629。

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Mahfoud F, Schlaich M, Schmieder RE, et al. Long-term outcomes in ESC guideline-recommended patients for RDN from Global SYMPLICITY Registry DEFINE. EuroPCR 2025.

马胡福 M，施莱希 M，施米德尔 RE，等。《全球SYMPLICITY注册研究DEFINE》中ESC指南推荐的RDN患者的长期结果。EuroPCR 2025。

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Kandzari DE et al. Long-term Safety and Efficacy of Radiofrequency Renal Denervation in the Presence of Antihypertensive Drugs: 24-Month Results from the SPYRAL HTN–ON MED Randomized Trial. TCT 2024

Kandzari DE 等。在抗高血压药物存在的情况下，射频肾去神经术的长期安全性和有效性：SPYRAL HTN–ON MED 随机试验的24个月结果。TCT 2024

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Bhatt, D. et al, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. The Lancet. September 18, 2022. DOI: DOI:

Bhatt, D. 等，导管为基础的肾动脉去神经术治疗顽固性高血压的长期结果：SYMPLICITY HTN-3 随机试验的最终随访。《柳叶刀》，2022年9月18日。DOI: DOI:

10.1016/S0140-6736(22)01787-1

10.1016/S0140-6736(22)01787-1

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Mahfoud, F. et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. August 2023;  DOI: 10.1161/HYPERTENSIONAHA.123.21283.

马胡福，F. 等。根据抗高血压药物对肾去神经术后的结果：全球SIMPLICITY注册DEFINE的亚组分析。《高血压》。2023年8月；DOI: 10.1161/HYPERTENSIONAHA.123.21283。

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Mahfoud F, et al. Long-term outcomes in ESC guideline-recommended patients for RDN from Global SYMPLICITY registry DEFINE. EuroPCR 2025

马胡福德·F等人。《全球SIMPLICITY注册研究DEFINE》中ESC指南推荐的RDN患者的长期结果。EuroPCR 2025

SOURCE Medtronic plc

来源：美敦力公司