Company commits to advancing clinical data for Symplicity™ with the SPYRAL Gemini clinical trial and expansion of the GSR-DEFINE clinical trial

该公司承诺通过SPYRAL Gemini临床试验和GSR-DEFINE临床试验的扩展，推进Symplicity™的临床数据

GALWAY, Ireland and WASHINGTON, Oct. 28, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced new, long-term data from its SPYRAL HTN-ON MED clinical trial that showed subjects who underwent radiofrequency renal denervation with the Symplicity™ Spyral renal denervation (RDN) system had significantly greater reductions in 24-hr ambulatory systolic blood pressure (ABPM), and office-based systolic blood pressure (OSBP) compared to sham patients at two years.

爱尔兰戈尔韦和华盛顿，2024年10月28日/PRNewswire/--医疗技术的全球领导者美敦力公司（纽约证券交易所：MDT）今天宣布了其SPYRAL HTN-ON MED临床试验的新的长期数据，该试验显示，与假手术患者相比，使用Symplicity™SPYRAL肾脏去神经支配（RDN）系统进行射频肾脏去神经支配的受试者在两年时24小时动态收缩压（ABPM）和办公室收缩压（OSBP）的降低幅度更大。

The data were presented as a part of the 2024 Transcatheter Cardiovascular Therapeutics Conference (TCT)..

这些数据是2024年经导管心血管治疗会议（TCT）的一部分。。

'These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension,' stated Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED trial.

皮埃蒙特心脏研究所和心血管服务主任兼SPYRAL HTN-ON MED试验首席首席研究员David Kandzari博士说：“这些发现是向医学界通报射频肾脏去神经支配治疗不受控制的高血压的长期有效性的关键一步。”。

'Importantly, at two years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed in across the SPYRAL and Global Symplicity clinical programs.'.

“重要的是，两年后，我们继续看到Symplicity是安全的，并且与临床上有意义且显着的血压降低相一致。这些数据进一步证实了在整个SPYRAL和全球Symplicity临床计划中始终观察到的持续血压降低。”。

The two-year data is consistent with other long-term data for Symplicity RDN, demonstrating clinically meaningful, consistent and sustained blood pressure reductions.1,2 At two years, the data showed:

两年的数据与Symplicity RDN的其他长期数据一致，表明血压降低具有临床意义，持续且持续。1,2两年的数据显示：

Significant group differences in 24-hr ABPM and OSBP in favor of RDN, despite significantly more medications detected in the sham group24 months ABPM: -12.1 mmHg in RDN group vs. -7.0 mmHg in sham group (treatment difference: -5.7 mmHg; p=0.039) OSBP: -17.4 mmHg in the RDN group vs. -9.0 mmHg in the sham group (treatment difference: -8.7 mmHg; p=0.0034)Long-term safety with no confirmed renal artery stenosis greater than 70% in the Spyral group at two yearsSPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Symplicity Spyral RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications.

24小时ABPM和OSBP的显着组间差异有利于RDN，尽管在假手术组中检测到明显更多的药物24个月ABPM:-RDN组为12.1 mmHg，假手术组为-7.0 mmHg（治疗差异：-5.7 mmHg；p=0.039）OSBP:-RDN组为17.4 mmHg，假手术组为-9.0 mmHg（治疗差异：-8.7 mmHg；p=0.0034）长期安全性，两年时Spyral组未确认肾动脉狭窄大于70%。Pyral HTN-ON MED是一项全球随机假对照试验，研究RDN与基于射频的Symplicity Spyral RDN系统在高血压患者中的降压效果和安全性，这些患者已开具多达三种抗高血压药物。

After the six-month primary endpoint assessment, the study continued to assess 24-hr ABPM and OSBP from baseline through yearly follow ups..

经过六个月的主要终点评估后，该研究继续从基线到年度随访评估24小时ABPM和OSBP。。

SPYRAL GEMINI Clinical ProgramMedtronic intends to investigate multi-organ (hepatic artery and renal artery) denervation with the Symplicity Spyral catheter. The planned Global Pilot study of rEnal and hepatic coMbINed denervatIon (SPYRAL GEMINI pilot study) will investigate the safety and efficacy of the multi-organ ablation approach in uncontrolled hypertension patients who are both on and off medications.  .

。计划中的肾脏和肝脏联合去神经支配全球试点研究（SPYRAL-GEMINI试点研究）将调查多器官消融方法在服用和停用药物的未控制高血压患者中的安全性和有效性。。

'Medtronic is uniquely positioned to explore the blood pressure lowering potential of multi-organ denervation. This is supported by both its intellectual property and the Symplicity Spyral catheter design, which enables access and treatment of the Common Hepatic Artery - a vascular target rich with sympathetic innervation - with the same single catheter,' said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic.

美敦力在探索多器官去神经支配的降血压潜力方面具有独特的地位。美敦力心血管投资组合高级副总裁兼冠状动脉和肾脏去神经支配业务总裁杰森·魏德曼（JasonWeidman）说，这得到了其知识产权和Symplicity Spyral导管设计的支持，该导管可以使用同一根导管进入和治疗肝总动脉，这是一种富含交感神经支配的血管靶点。

'The promising preclinical data highlight the potential for interventional denervation in the liver to support additional blood pressure lowering effects of the procedure.3 This approach underscores our dedication to innovation for both patients and physicians.'.

“有希望的临床前数据突出了肝脏介入性去神经支配的潜力，以支持该手术的额外降血压效果[3]。这种方法强调了我们致力于为患者和医生进行创新。”。

The utilization of Symplicity Spyral in the hepatic artery is investigational and not approved for use.

Symplicity Spyral在肝动脉中的使用是研究性的，未被批准使用。

GSR-DEFINE Expands to the United StatesMedtronic will also expand the GSR-DEFINE clinical trial to sites in the United States. The GSR-DEFINE trial is an extension of the Global SYMPLICITY Registry, and is a prospective, all-comer observational study in 251 sites across 55 countries, including 3,000 patients from the GSR study and enrolling up to an additional 2,000 patients globally..

GSR-DEFINE扩展到美国Medtronic还将GSR-DEFINE临床试验扩展到美国的网站。GSR-DEFINE试验是全球SYMPLICITY登记处的延伸，是一项前瞻性的全方位观察性研究，在55个国家的251个地点进行，其中包括3000名来自GSR研究的患者，并在全球范围内招募了多达2000名患者。。

'This year at TCT, we are not only reinforcing the consistent, long-term effects of radiofrequency denervation, but we're further demonstrating our commitment to evidence generation and innovation,' said Jason Fontana, PhD, general manager Renal Denervation, and vice president of Global Marketing for the Coronary and Renal Denervation business.

肾脏去神经支配总经理兼冠状动脉和肾脏去神经支配业务全球营销副总裁Jason Fontana博士说：“今年在TCT，我们不仅加强了射频去神经支配的持续长期效果，而且进一步证明了我们对证据生成和创新的承诺。”。

'As the leader in interventional hypertension treatments, we are excited to extend the largest evidence platform available to U.S. physicians and their patients.'.

“作为介入性高血压治疗的领导者，我们很高兴能够为美国医生及其患者提供最大的证据平台。”。

Approved for commercial use in over 75 countries around the world, the Symplicity Spyral renal denervation system is currently limited to investigational use in Japan.

Symplicity Spyral肾脏去神经支配系统已被批准在全球75多个国家商业使用，目前仅限于日本的研究用途。

About MedtronicBold 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.

关于美敦力思维。更大胆的行动。我们是美敦力。总部位于爱尔兰戈尔韦的美敦力公司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，延长生命，我们将150多个国家的95000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 follow Medtronic on 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。。。

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。

1 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 randomised, sham-controlled trial. The Lancet. 2022; 399:1401-1410.2 GSR 2024 update: Mahfoud et al.EuroPCR. 20243 Tzafriri, A.R., et al Morphometric analysis of the human common hepatic artery reveals a rich and accessible target for sympathetic liver denervation.

1 Mahfoud F，Kandzari DE，Kario K等人。抗高血压药物（SPYRAL HTN-ON MED）存在下肾脏去神经支配的长期疗效和安全性：一项随机，假对照试验。柳叶刀。2022年；399:1401-1410.2 GSR 2024更新：Mahfoud et al.EuroPCR。20243 Tzafriri，A.R。等人对人类肝总动脉的形态计量学分析揭示了交感神经肝脏去神经支配的丰富且可接近的靶标。

Sci Rep 12, 1413 (2022). https://doi.org/10.1038/s41598-022-05475-6.

Sci Rep 12, 1413 (2022). https://doi.org/10.1038/s41598-022-05475-6.

Contacts:

联系人：

Krystin Hayward Leong       Public Relations       +1-508-261-6512

Krystin Hayward Leong公共关系+1-508-261-6512

Ryan Weispfenning   Investor Relations+1-763-505-4626

Ryan Weispfenning投资者关系+1-763-505-4626

SOURCE Medtronic plc

来源美敦力plc