Medtronic plc, a global leader in healthcare technology, today announced the completion of enrollment and the first results from the High Cardiovascular Risk Patient Cohort of the SPYRAL AFFIRM study. This first report demonstrated significant, safe, and sustained blood pressure reductions with the Symplicity™ Spyral renal denervation (RDN) system, with no increase in anti-hypertensive medication use at six months.

医疗器械公司美敦力（Medtronic plc）今日宣布，SPYRAL AFFIRM 研究的高心血管风险患者队列已完成入组，并发布了初步结果。首次报告显示，使用Symplicity™ Spyral肾动脉去神经术（RDN）系统可实现显著、安全且持续的血压降低，并且在六个月时未增加抗高血压药物的使用。

The data was presented today as Featured Clinical Research during the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference..

该数据在2025年经导管心血管治疗（TCT）会议期间作为特色临床研究展示。

Data from a cohort of 210 patients from 59 sites across Europe, Australia and the United States demonstrated significant reductions in both home and office systolic blood pressure (SBP) across multiple high-risk subgroups, including those with isolated systolic hypertension (ISH), diabetes mellitus (DM), and chronic kidney disease (CKD), with no increase in anti-hypertensive medication use.

来自欧洲、澳大利亚和美国59个地点的210名患者的数据表明，在多个高风险亚组中，家庭和办公室收缩压（SBP）均显著下降，这些亚组包括单纯收缩期高血压（ISH）、糖尿病（DM）和慢性肾病（CKD）患者，且抗高血压药物的使用没有增加。

Additionally, the number of prescribed anti-hypertensive medications remained stable across all groups, and no major safety events were observed, further validating the safety of the Symplicity blood pressure procedure in high-risk patients..

此外，所有组中处方的抗高血压药物数量保持稳定，且未观察到重大安全事件，这进一步验证了Symplicity血压手术在高危患者中的安全性。

“This first results from the SPYRAL AFFIRM study demonstrates significant, safe, and sustained blood pressure reductions in a high cardiovascular risk patient population that has limited therapeutic options and yet a higher likelihood of adverse events,” said Felix Mahfoud, MD, cardiologist at Basel University Heart Center, Switzerland and presenting author of the SPYRAL AFFIRM study.

“SPYRAL AFFIRM 研究的首批结果表明，在心血管高风险患者群体中，这种治疗方法能够显著、安全且持续地降低血压。这类患者治疗选择有限，且发生不良事件的可能性更高，”瑞士巴塞尔大学心脏中心的心脏病专家、SPYRAL AFFIRM 研究报告作者 Felix Mahfoud 医学博士表示。

“Seeing positive outcomes in this population underlines why renal denervation is recommended as an adjunctive therapy in U.S. and European hypertension guidelines, helping to reduce blood pressure and improve long-term cardiovascular outcomes.”.

“在这一人群中看到积极的结果，强调了为什么肾去神经术被推荐为美国和欧洲高血压指南中的辅助疗法，有助于降低血压并改善长期心血管结局。”

At six months, high-risk cardiovascular patients treated with the Symplicity Spyral RDN system in this first report demonstrated clinically meaningful and statistically significant reductions in blood pressure, for readings both in-office and at-home at six months:

六个月时，这份首份报告中使用Symplicity Spyral RDN系统治疗的高危心血管患者显示出在血压方面的临床显著性和统计学显著性降低，无论是在办公室还是在家中的六个月读数均如此：

DM group: −13.3 mmHg (office) and −5.9 mmHg (home)

DM组：−13.3 mmHg（诊室）和−5.9 mmHg（家庭）

ISH group: −10.6 mmHg (office) and −4.6 mmHg (home)

ISH组：−10.6 mmHg（诊室）和−4.6 mmHg（家庭）

CKD group: −19.3 mmHg (office) and −5.4 mmHg (home)

CKD组：−19.3 mmHg（诊室）和−5.4 mmHg（家庭）

Additionally, Medtronic announced completion of enrollment of the full cohort of the SPYRAL AFFIRM study, adding to the body of evidence for Symplicity Spyral RDN system. The SPYRAL AFFIRM study is a prospective, international, multicenter, single-arm trial evaluating the safety and efficacy of the Symplicity Spyral RDN system in a real-world cohort of 987 patients across 100 sites, with more than 50 percent of participants enrolled in the U.S..

此外，美敦力宣布已完成SPYRAL AFFIRM研究的全队列入组，为Symplicity Spyral RDN系统增加了证据支持。SPYRAL AFFIRM研究是一项前瞻性、国际性、多中心、单臂试验，评估Symplicity Spyral RDN系统在来自100个地点的987名真实世界患者中的安全性和有效性，其中超过50%的参与者来自美国。

“Completing enrollment in the SPYRAL AFFIRM study reinforces our commitment to building the most robust body of real-world evidence in the field of renal denervation,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular portfolio at Medtronic.

“完成SPYRAL AFFIRM研究的入组工作进一步加强了我们在肾去神经领域建立最有力的真实世界证据体系的承诺，”美敦力心血管产品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。

‘Specifically, this study will allow us to evaluate the technology across clinically diverse and traditionally underserved patient populations — like high cardiovascular risk patients — whose blood pressure remains uncontrolled despite medication and lifestyle modifications.”.

“具体而言，这项研究将使我们能够评估该技术在临床多样性和传统上服务不足的患者群体中的应用情况，例如心血管病高危患者，他们的血压尽管服用了药物并进行了生活方式调整，但仍然无法控制。”

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

Symplicity RDN系统已在近80个国家获准用于商业用途。

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.

大胆的思考。更果敢的行动。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，大胆地应对人类面临的最严峻的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

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。凭借我们广泛的知识、无尽的好奇心和帮助所有有需要的人的愿望，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, visit .

我们致力于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，因此请对我们有更多期待。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。

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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所述的风险和不确定性。实际结果可能与预期结果有重大差异。

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