Medtronic today announced the first U.S. patient treated in the Global SYMPLICITY Registry (GSR) DEFINE clinical trial, documenting the safety and effectiveness of the Symplicity™ Spyral renal denervation (RDN) system in a real-world setting. The first procedure was performed by Dr. Stan Thornton of Thomas Hospital, an affiliate of Infirmary Health in Fairhope, Alabama..

美敦力公司今天宣布了全球SYMPLICITY注册研究（GSR）DEFINE临床试验中首例美国患者接受治疗，该试验记录了Symplicity™ Spyral肾去神经（RDN）系统在真实世界环境中的安全性和有效性。首次手术由阿拉巴马州费尔霍普Infirmary Health旗下托马斯医院的斯坦·索顿医生完成。

“The first patient enrolled in the U.S. expansion of the GSR-DEFINE registry marks a major milestone for the commercial rollout of the Symplicity Spyral RDN system,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic.

“GSR-DEFINE注册研究在美国扩展中的首位患者入组标志着Symplicity Spyral RDN系统商业推广的一个重要里程碑，”美敦力心血管业务组合中冠状动脉与肾去神经业务的高级副总裁兼总裁Jason Weidman表示。

“We are committed to generating valuable real-world evidence and supporting our mission to make this breakthrough procedure available to the people who need it most.”.

“我们致力于生成有价值的现实世界证据，并支持我们的使命，将这一突破性手术提供给最需要它的患者。”

The GSR-DEFINE trial is an extension of the Global SYMPLICITY Registry, the largest study documenting the long-term safety and effectiveness of the Symplicity Spyral RDN system in a real-world setting in patients with uncontrolled hypertension. At the recent EuroPCR conference in Paris, Medtronic reported that GSR showed three-year declines in office systolic blood pressure of 16.3 mm Hg in 1,450 patients evaluated from outside the U.S.

GSR-DEFINE 试验是全球 SYMPLICITY 注册研究的延伸，该注册研究是规模最大的研究，记录了 Symplicity Spyral RDN 系统在真实世界中对未受控制的高血压患者长期安全性和有效性的数据。在最近于巴黎举行的欧洲经皮心血管介入大会（EuroPCR）上，美敦力公司报告称，GSR 显示，在来自美国以外的 1450 名患者中，诊室收缩压在三年内下降了 16.3 毫米汞柱。

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With over 4,000 patients already enrolled outside of the U.S., GSR-DEFINE is a prospective, all-comer observational study in 251 sites across 55 countries including 5,000 patients globally.

GSR-DEFINE是一项前瞻性、全人群观察性研究，覆盖55个国家的251个站点，全球范围内包括5000名患者，其中已有4000多名患者在美国以外地区注册。

“The U.S. GSR-DEFINE study builds on the Global SYMPLICITY Registry with the goal of enhancing our understanding of how renal denervation can improve outcomes for U.S. patients with uncontrolled hypertension in everyday clinical practice,” said Stan Thornton, MD, Cardiologist at Cardiology Associates at Thomas Hospital and Principal Investigator for the U.S.

“美国的GSR-DEFINE研究基于全球SYMPLICITY注册研究，目标是加强对肾去神经术如何在日常临床实践中改善美国未控制高血压患者的预后的理解，”托马斯医院心脏病学协会的心脏病学家、美国首席研究员斯坦·桑顿医学博士说道。

GSR DEFINE registry study. “We are proud to begin enrolling patients in the trial and treating patients with the Symplicity blood pressure procedure – a promising solution for millions worldwide in need of alternative solutions.”.

GSR定义注册研究。“我们很自豪能够开始招募试验患者，并使用Symplicity血压手术治疗患者——这是一种为全球数百万需要替代治疗方案的患者带来的有前景的解决方案。”

Hypertension, or high blood pressure, impacts more than 1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death.

高血压，或称血压升高，影响着全球超过10亿成年人，是心脏病发作、中风和死亡的主要可改变原因。

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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得不到控制。近80%的高血压成年人没有将其控制住。

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

而一半的高血压患者在一年内变得不依从药物治疗。

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The Symplicity RDN system is approved for commercial use in over 75 countries around the world.

Symplicity RDN系统已在世界范围内超过75个国家获得商业使用批准。

About Medtronic

美敦力公司简介

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，通过寻找和发现解决方案，大胆攻克人类面临的最严峻健康问题。我们的使命——减轻病痛、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、无尽的好奇心和帮助所有需要帮助的人的愿望，我们提供创新技术，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 .

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，期待我们做出更多贡献。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。

www.Medtronic.com

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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.

任何前瞻性陈述都受到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描述的那些。实际结果可能与预期结果有重大差异。

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Mahfoud F, et al. EuroPCR 2025. Results include Symplicity Spyral and Flex catheters

马胡福德·F等人。2025年欧洲经皮心血管介入会议。结果包括Symplicity Spyral和Flex导管。

2 WHO. Hypertension fact sheet. September 13, 2019.

2 世界卫生组织。高血压事实清单。2019年9月13日。

Available at:

可从以下地址获取：

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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Accessed February 15, 2022.

访问日期：2022年2月15日。

3 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomized, sham-controlled trial. The Lancet. 2022; 399:1401-1410.

3 Mahfoud F、Kandzari DE、Kario K等。在抗高血压药物存在的情况下肾去神经术的长期有效性和安全性（SPYRAL HTN-ON MED）：一项随机、假手术对照试验。《柳叶刀》。2022年；399:1401-1410。

4 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:

4 Bhatt, D. 等，导管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:

https://doi.org/10.1016/S0140-6736(opens new window)

https://doi.org/10.1016/S0140-6736(打开新窗口)

(22)01787-1.

(22)01787-1。