/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system..

/-- 全球医疗技术领导者美敦力（纽约证券交易所代码：MDT）今天宣布，Expand URO研究设备豁免（IDE）临床研究已达成主要安全性和有效性终点。这是迄今为止规模最大的机器人辅助泌尿外科手术研究。这项前瞻性、多中心、单臂IDE研究包括137名使用Hugo™机器人辅助手术（RAS）系统进行泌尿外科手术的患者。

The data, described by the American Urologic Association (AUA) as a 'practice-changing, paradigm-shifting (P2) clinical trial in urology', was presented today at the AUA annual meeting in

美国泌尿协会 (AUA) 称其为“改变实践、转变范式的 (P2) 泌尿科临床试验”的数据，于今日在 AUA 年会上发布。

Las Vegas

拉斯维加斯

by

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Michael R. Abern

迈克尔·R·阿伯恩

, M.D., the study's national principal investigator and a urologic surgeon at Duke University Hospital in Durham, N.C.

医学博士，该研究的全国主要研究者，北卡罗来纳州达勒姆杜克大学医院的泌尿外科医生。

'The study demonstrated that the Hugo RAS system met the safety and effectiveness endpoints, and the outcomes are consistent with published literature for robotic-assisted urologic surgery,' said Dr. Abern. 'Having performed the first case in the Expand URO clinical study, it's incredibly rewarding to see the results of this rigorous and important study in the field of robotic surgery.'.

“该研究表明，Hugo RAS 系统达到了安全性和有效性终点，且结果与已发表的机器人辅助泌尿外科手术文献一致，”阿伯恩博士说道。“作为 Expand URO 临床研究中的首例手术执行者，看到这项在机器人手术领域严谨而重要的研究成果，感到非常欣慰。”

About the Expand URO clinical study:

关于Expand URO临床研究：

On average, patients were approximately 63 years old and classified as American Society of Anesthesiologists (ASA) category ≥3, indicating they had severe systematic disease or condition impacting their overall health.

患者的平均年龄约为63岁，被归类为美国麻醉医师协会（ASA）分级≥3级，表明他们患有严重的系统性疾病或影响其整体健康的状况。

11 surgeons across 6 hospitals in the U.S. performed 3 types of urologic procedures — prostatectomies (prostate removal; n=55), nephrectomies (kidney removal; n=53), and cystectomies (bladder removal; n=29).

美国6家医院的11名外科医生进行了3种泌尿外科手术——前列腺切除术（前列腺移除；n=55）、肾切除术（肾脏移除；n=53）和膀胱切除术（膀胱移除；n=29）。

The common patient cohorts were prostate cancer in prostatectomy, renal tumors in nephrectomy, and bladder tumors in cystectomy.

常见的患者队列包括前列腺切除术中的前列腺癌、肾切除术中的肾肿瘤以及膀胱切除术中的膀胱肿瘤。

The study was conducted with a high degree of rigor consistent with the FDA premarket requirements and included prospective enrollment and data collection, independent event adjudication by a Clinical Events Committee (surgeon advisory group), data monitoring and excellent follow-up compliance with approximately 98% of patients completing the 30-day follow-up..

该研究以与FDA上市前要求一致的高度严谨性进行，包括前瞻性注册和数据收集、由临床事件委员会（外科医生顾问组）独立进行事件裁定、数据监控以及出色的随访依从性，约98%的患者完成了30天的随访。

All cancer patients in the study will be followed for five years.

研究中的所有癌症患者都将接受五年的随访。

Expand URO study primary endpoint data:

扩展URO研究主要终点数据：

Safety: The rates of grade 3 or higher complications (3.7% prostatectomy, 1.9% nephrectomy, and 17.9% cystectomy) were favorably below the performance goals (20% prostatectomy, 20% nephrectomy, and 45% cystectomy; p=0.0006, p=0.0001, p=0.0025, respectively), which were established based on systematic review of published literature across all three cohorts..

安全性：3级或更高级别并发症的发生率（前列腺切除术3.7%，肾切除术1.9%，膀胱切除术17.9%）均低于预期目标（前列腺切除术20%，肾切除术20%，膀胱切除术45%；p=0.0006，p=0.0001，p=0.0025），这些目标是基于对所有三个队列已发表文献的系统性回顾确定的。

Effectiveness: The study's 98.5% surgical success rate was well above the performance goal of 85% (p<0.0001), which was established based on a systematic review of published literature. There were two conversions: one was related to the device and one was related to patient anatomy.

有效性：该研究98.5%的手术成功率远高于基于已发表文献系统综述所设定的85%的表现目标（p<0.0001）。共有两例转换：一例与设备相关，另一例与患者解剖结构相关。

'The Expand URO clinical study provides important clinical evidence about the Hugo RAS system and is an exciting milestone that brings us closer to our goal of offering surgeons in the U.S. long-awaited choice in robotic technology,' said

“Expand URO 临床研究为 Hugo RAS 系统提供了重要的临床证据，这是一个令人兴奋的里程碑，使我们更接近为美国外科医生提供期待已久的机器人技术选择的目标，”

James Porter

詹姆斯·波特

, M.D., chief medical officer, Robotic Surgical Technologies and Digital Technologies within the Surgical business, part of the Medical Surgical portfolio at Medtronic, and a urologic surgeon at Swedish Medical Center in

，医学博士，美敦力医疗外科产品组合中手术业务部门机器人手术技术与数字技术的首席医疗官，同时也是瑞典医学中心的泌尿外科医生，在

Seattle, WA.

华盛顿州西雅图市。

'Surgeons want to deliver the best care to our patients and robotic technology is key to making that possible today by enabling minimally invasive surgery and leveraging technology that is shaping the future of surgery.'

“外科医生希望为患者提供最好的治疗，而机器人技术是实现这一目标的关键，它通过启用微创手术和利用正在塑造外科手术未来的技术使之成为可能。”

U.S. FDA submission for the Hugo RAS system

美国FDA提交的Hugo RAS系统

Medtronic also announced today that it submitted the Hugo RAS system to the U.S. Food and Drug Administration (FDA) for a urologic indication in the first quarter of calendar 2025.

美敦力公司今天还宣布，它在2025年日历年第一季度向美国食品药品监督管理局（FDA）提交了Hugo RAS系统用于泌尿科适应症的申请。

The FDA submission is the company's latest milestone toward a planned entrance into the U.S., the world's largest robotic surgery market. In February, the company shared that it completed enrollment in both its hernia and benign gynecology (GYN) studies and received approval to start a new clinical study including oncologic GYN procedures — all in support of planned submissions to the FDA for additional indications beyond urology for the Hugo RAS system in the U.S..

向FDA提交申请是该公司计划进入全球最大的机器人手术市场——美国——的最新里程碑。今年2月，该公司表示已完成其疝气和良性妇科（GYN）研究的入组，并获得批准开始一项新的临床研究，其中包括妇科肿瘤手术——所有这些都旨在支持向FDA提交申请，以在美国为Hugo RAS系统申请泌尿科以外的更多适应症。

Outside the U.S., the Hugo RAS system is in clinical use in more than 25 countries across 5 continents, with a growing body of evidence including more than 200 independent papers published to date.

在美国以外，Hugo RAS 系统已在五大洲的 25 个国家投入临床使用，目前已有 200 多篇独立发表的论文，证据基础不断扩充。

Medtronic thoughtfully designed the Hugo RAS system — through collaboration with hundreds of surgeons and hospital leaders globally — with the goal of expanding access to minimally invasive care to more patients around the world. The Hugo RAS system delivers the benefits of RAS in a flexible, modular form factor and open surgeon console that supports communication among the surgical team.

美敦力通过与全球数百名外科医生和医院领导者合作，精心设计了Hugo RAS系统，旨在让世界各地更多患者能够获得微创护理。Hugo RAS系统以灵活、模块化的形式和开放的外科医生操作台提供机器人辅助手术的优势，支持手术团队之间的沟通。

Paired with the Touch Surgery™ ecosystem, the Hugo RAS system offers a smart, connected surgical experience that is shaping the future of surgery..

与Touch Surgery™生态系统相结合，Hugo RAS系统提供了一种智能、互联的手术体验，正在塑造手术的未来。

The Hugo RAS system is not cleared or approved in all markets. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the U.S., the Hugo RAS system is an investigational device not for sale.

Hugo RAS 系统并未在所有市场获得批准或 clearance。各个国家和地区的监管要求将决定其批准、clearance 或市场可用性。在美国，Hugo RAS 系统属于研究用设备，尚未上市销售。

†The evaluation did not include assessment of outcomes related to the treatment of cancer or any specific treatment of any underlying disease or condition.

†评估未包括与癌症治疗或任何基础疾病或状况的特定治疗相关的结果评估。

‡Touch Surgery ecosystem is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition; Live Stream and performance insights are only intended for education and training purposes.

‡Touch Surgery生态系统并非用于指导手术，或辅助疾病的诊断或治疗；直播和性能洞察仅用于教育和培训目的。

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。更果断的行动。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，勇敢地应对人类面临的最严峻的健康问题，积极寻找并发现解决方案。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，我们提供了创新技术，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 (NYSE: MDT), visit .

对我们有更多期待，因为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。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。