/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced two U.S. Food and Drug Administration (FDA) regulatory milestones that broaden the MiniMed™ 780G system portfolio: clearance of the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval of the MiniMed™ 780G system for use in adults 18+ with insulin-requiring type 2 diabetes..

/-- 医疗技术全球领导者美敦力公司（纽约证券交易所代码：MDT）今天宣布了两项美国食品药品监督管理局（FDA）的监管里程碑，进一步扩展了MiniMed™ 780G系统产品组合：SmartGuard™算法被批准为可互操作的自动血糖控制器（iAGC），能够与雅培公司生产的Instinct传感器集成，用于1型糖尿病患者；同时，MiniMed™ 780G系统也获批用于18岁及以上需要胰岛素治疗的2型糖尿病成人患者。

'These milestones mark an important next step in our work to bring the proven performance and outcomes of our MiniMed™ 780G automated insulin delivery system to more people living with diabetes. By enabling integration with the Instinct sensor and expanding the MiniMed™ 780G system to people with type 2 diabetes, we are advancing a smart dosing ecosystem designed to provide greater choice and flexibility, along with a more seamless experience,' said Que Dallara, Executive Vice President and President of Medtronic Diabetes and CEO Designate of MiniMed.

“这些里程碑标志着我们在将MiniMed™ 780G自动胰岛素输送系统的卓越性能和成果带给更多糖尿病患者的工作中迈出了重要的下一步。通过实现与Instinct传感器的集成，并将MiniMed™ 780G系统扩展至2型糖尿病患者，我们正在推动一个智能剂量生态系统的进步，旨在提供更多的选择和灵活性，以及更加无缝的体验。”美敦力糖尿病业务执行副总裁兼总裁、MiniMed首席执行官指定人Que Dallara表示。

'We're excited to expand our ecosystem of solutions under one roof with service our customers can count on around the clock.'.

“我们很高兴在一个屋檐下扩展我们的解决方案生态系统，并提供客户可以全天候信赖的服务。”

This clearance, alongside the previously cleared MiniMed™ 780G insulin pump as an alternate controller enabled (ACE) pump, completes the Medtronic FDA pre-market approval pathway for the Instinct sensor integration with our MiniMed™ 780G system for people living with type 1 diabetes. The Instinct sensor, designed exclusively by Abbott for MiniMed™ automated insulin delivery (AID) and Smart MDI systems, is the world's smallest.

这一许可连同之前获批的MiniMed™ 780G胰岛素泵（作为替代控制器启用的ACE泵），完成了美敦力针对Instinct传感器与我们的MiniMed™ 780G系统集成的FDA上市前审批路径，适用于1型糖尿病患者。Instinct传感器由雅培专为MiniMed™自动胰岛素输送（AID）和Smart MDI系统设计，是世界上最小的传感器。

integrated CGM (iCGM) and offers a wear time of up to 15 days.

集成的CGM（iCGM），最长可佩戴15天。

In the coming weeks, Medtronic and Abbott plan to complete their required compliance documentation enabling sensor integration and marketing. Completion of this step will promptly finalize the regulatory process, after which ordering for the Instinct sensor with the MiniMed™ 780G system will begin. Existing customers will have priority access through the Innovations Program.

在未来几周内，美敦力和雅培计划完成其所需的合规文件，以实现传感器集成和上市。这一步骤的完成将迅速结束监管流程，之后便可以开始订购配备MiniMed™ 780G系统的Instinct传感器。现有客户将通过创新计划获得优先访问权。

Pre-orders for Simplera Sync™ sensor will also begin later this month..

本月晚些时候，Simplera Sync™ 传感器的预购也将开始。

'We're working together to do what's best for people living with diabetes,' said

“我们正在共同努力，为糖尿病患者做最好的事情，”

Chris Scoggins

克里斯·斯科金斯

, Executive Vice President of Abbott's diabetes care business. 'Abbott's biowearable technology has long set the standard for accurate, accessible, easy-to-use continuous glucose monitoring. Connecting it with the MiniMed™ 780G system aims to reduce the mental load of daily management, making it easier for people to live with diabetes.'.

雅培糖尿病护理业务执行副总裁。“雅培的生物可穿戴技术长期以来一直是准确、易获取、易于使用的连续葡萄糖监测标准。将其与MiniMed™ 780G系统连接，旨在减轻日常管理的精神负担，使糖尿病患者的生活更加轻松。”

Expanding Indications for Type 2 Diabetes

2型糖尿病的适应症扩展

Separately, the FDA approved the MiniMed™ 780G system for people with insulin-requiring type 2 diabetes, making it the first and only automated insulin delivery (AID) system with Meal Detection™ technology* available to this population.

另外，FDA 还批准了 MiniMed™ 780G 系统用于需要胰岛素的 2 型糖尿病患者，这使得该系统成为第一个也是唯一一个可供此人群使用的具有餐食检测技术的自动胰岛素输送系统。

'This approval extends the benefits of automated insulin delivery to people with type 2 diabetes,' said

“该批准将自动胰岛素输送的好处扩展到 2 型糖尿病患者，”

Natalie Bellini

娜塔莉·贝里尼

, DNP, FNP, BC-ADM, CDCES, Endocrine Nurse Practitioner and Program Director for Diabetes Technology at University Hospitals in

，DNP，FNP，BC-ADM，CDCES，内分泌科护士执业者及大学医院糖尿病技术项目主任在

Cleveland, Ohio

克利夫兰，俄亥俄州

. 'It also aligns with the ADA Standards of Care, which now formally endorse AID systems for individuals with type 2 diabetes on intensive insulin therapy.'

这也符合ADA护理标准，该标准现在正式认可AID系统用于接受强化胰岛素治疗的2型糖尿病患者。

People living with type 2 diabetes who require insulin face daily challenges that affect both their physical health and emotional well-being, including frequent injections, meal planning, and glucose monitoring. Clinical evidence demonstrates that use of the MiniMed™ 780G system can improve glycemic outcomes and reduce treatment burden..

生活在2型糖尿病中的患者需要胰岛素，他们面临着影响身体健康和情绪健康的日常挑战，包括频繁注射、饮食规划和血糖监测。临床证据表明，使用MiniMed™ 780G系统可以改善血糖结果并减轻治疗负担。

In a recently published pivotal trial

在最近发表的一项关键试验中

(n=95) with the Guardian™ 4 sensor and Simplera Sync™ sensor, participants experienced a 0.7% reduction in HbA1c (from a baseline of 7.9%) and an increase in Time in Range to 81% (from a baseline of 72%), with minimal hypoglycemia.

(n=95) 使用 Guardian™ 4 传感器和 Simplera Sync™ 传感器的参与者，HbA1c 水平降低了 0.7%（从基线的 7.9%），并且血糖在目标范围内的时间增加到 81%（从基线的 72%），同时低血糖发生率极低。

In a separate single-arm study

在一项单独的单臂研究中

(n=236), A1C decreased from 7.7% to 6.9%, and Time in Range increased from 76.4% to 84.9% during 90 days of advanced hybrid closed-loop use with low time-below-range (70 mg/dL) of 0.3%. Participants also reported improvements in quality of life and reductions in diabetes distress.

(n=236)，在使用高级混合闭环系统90天后，A1C从7.7%下降到6.9%，血糖在目标范围内的时间从76.4%增加到84.9%，且低于范围（70 mg/dL）的时间仅为0.3%。参与者还报告了生活质量的改善和糖尿病困扰的减少。

The MiniMed™ 780G system is currently available for type 2 diabetes with the Guardian™ 4 sensor and will be available with Simplera Sync™ sensor when pre-orders begin later this month. Medtronic also plans to submit 510(k) applications seeking clearance for an interoperable pump indicated for type 2 diabetes, which would enable future integration with the Instinct sensor..

MiniMed™ 780G系统目前可与Guardian™ 4传感器配合使用于2型糖尿病，并将在本月晚些时候开始预购时提供与Simplera Sync™传感器的配合使用。美敦力还计划提交510(k)申请，寻求获批一款用于2型糖尿病的可互操作泵，以便未来能够与Instinct传感器集成。

About the Diabetes Business at Medtronic

关于美敦力的糖尿病业务

Medtronic Diabetes is on a mission to make diabetes more predictable, so everyone can embrace life to the fullest with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront..

美敦力糖尿病部门致力于让糖尿病的管理更加可预测，使每个人都能通过最先进的糖尿病技术和随时随地的支持，充分享受生活。四十多年来，我们始终致力于开创前所未有的创新技术，并通过下一代传感器（CGM）、智能给药系统以及数据科学和人工智能的力量，规划糖尿病管理的未来，同时始终将客户体验置于首位。

About Medtronic

关于美敦力

Medtronic 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.

美敦力是全球领先的医疗技术公司，大胆攻克人类面临的最棘手健康问题，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, 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，敬请期待我们的更多成果。在我们所做的一切中，我们正在创造非凡的工程。欲了解有关美敦力的更多信息，请访问。