Medtronic, a global leader in healthcare technology, today announced 12-month data from a clinical trial (NCT05177354) demonstrating the benefits of its Inceptiv™ closed-loop spinal cord stimulator (CL-SCS) in patients with chronic Low-back pain (CLBP) and leg pain. The data will be presented at the North American Neuromodulation Society (NANS) 2025 meeting, taking place January 30 – February 1, in Orlando, Florida.

全球医疗技术领导者美敦力今天宣布了一项临床试验（NCT05177354）的12个月数据，证明了其Inceptiv™闭环脊髓刺激器（CL-SCS）对慢性腰痛（CLBP）和腿痛患者的益处。这些数据将在1月30日至2月1日于佛罗里达州奥兰多举行的北美神经调节学会（NANS）2025会议上公布。

In all, the company is highlighting 22 data presentations reflecting evidence from Medtronic-sponsored research and collaborations with external partners. .

总的来说，该公司重点介绍了22个数据演示，反映了美敦力赞助的研究以及与外部合作伙伴合作的证据。。

The Inceptiv™ spinal cord stimulator, which received FDA approval in April 2024, senses

2024年4月获得FDA批准的Inceptiv™脊髓刺激器能够感知

biological signals along the spinal cord and automatically adjusts stimulation in real time. The objective of the prospective, multi-center, single-arm “Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop SCS System” study is to characterize the efficacy of the Inceptiv SCS system for treating chronic neuropathic pain and improving quality of life.

沿着脊髓发出生物信号，并实时自动调整刺激。前瞻性，多中心，单臂“美敦力闭环SCS系统长期患者体验评估”研究的目的是表征Inceptiv SCS系统治疗慢性神经性疼痛和改善生活质量的功效。

Patients were randomized with closed-loop On/Off periods..

患者随机分为闭环开/关期。。

Key 12-month findings from the study include:

该研究为期12个月的主要发现包括：

93% of patients reported a reduction in overstimulation with the CL feature during in-clinic testing (n=43)

93%的患者报告在临床测试期间CL特征的过度刺激减少（n=43）

88% of patients preferred having the CL feature On (vs. Off; n = 43)

88%的患者倾向于开启CL功能（与关闭相比；n=43）

At-home experience was consistent with the in-clinic testing results – 91% of participants (n = 46) reported not experiencing uncomfortable stimulation during activities of daily living

家庭体验与临床测试结果一致–91%的参与者（n=46）报告在日常生活活动中没有经历不舒服的刺激

82% reported 50% or more reduction in low-back pain intensity with a mean reduction of 67% (n = 38)

82%的人报告腰痛强度降低了50%或更多，平均降低了67%（n=38）

50% were able to reduce or stop the use of opioid medications (n=32 with MME>0 at baseline)

50%的人能够减少或停止使用阿片类药物（n=32，基线时MME>0）

87% of subjects (n = 46) improved in 3 or more domains of a composite endpoint that includes pain (VAS reduction ≥30%), QoL (EQ-5D-5L increase ≥0.074), physical function (Oswestry Disability Index reduction≥10), mood (POMS reduction ≥10) and sleep quality (PSQI reduction ≥3.0)

87%的受试者（n=46）在复合终点的3个或更多领域有所改善，包括疼痛（VAS降低≥30%），生活质量（EQ-5D-5L增加≥0.074），身体功能（Oswestry残疾指数降低≥10），情绪（POMS降低≥10）和睡眠质量（PSQI降低≥3.0）

With the closed-loop feature on, patients made only 1 median adjustment to programming every 30 days. By comparison, in a U.S. SCS patient market research survey across multiple manufacturers, 50% of participants (n = 100) made frequent adjustments at least a few times per week.

启用闭环功能后，患者每30天仅对编程进行1次中位数调整。相比之下，在多家制造商的美国SCS患者市场研究调查中，50%的参与者（n=100）每周至少进行几次频繁调整。

100% of subjects (n = 46) expressed satisfaction with CL-SCS therapy and 98% would recommend to friends and family

100%的受试者（n=46）对CL-SCS治疗表示满意，98%的受试者会向朋友和家人推荐

“The 12-month data demonstrate that Inceptiv with closed-loop technology provides significant benefits in improving pain, quality of life and physical function scores while substantially reducing overstimulation,” said Dr. Vahid Mohabbati, MD, director of the Sydney Pain Research Centre in Sydney, Australia and an investigator on the trial.

澳大利亚悉尼疼痛研究中心主任兼试验研究人员Vahid Mohabbati博士说：“12个月的数据表明，采用闭环技术的Inceptiv在改善疼痛、生活质量和身体功能评分的同时，大大减少了过度刺激。”。

“The findings that 50% of patients were able to decrease or discontinue opioid pain medication and the median number of times that patients adjusted their stimulation amplitude was only once every 30 days underscore that Inceptiv with closed-loop sensing can reduce treatment burden while providing effective pain relief.

“50%的患者能够减少或停止阿片类止痛药治疗，患者调整刺激幅度的中位数仅为每30天一次，这一发现强调了闭环感应的接收可以减轻治疗负担，同时提供有效的疼痛缓解。

These results emphasize the importance of tailoring stimulation and ensuring consistency of dosing for optimal benefits from SCS therapy as patients engage in activities of daily living.”  .

这些结果强调了定制刺激和确保剂量一致性的重要性，以便在患者参与日常生活活动时从SCS治疗中获得最佳益处。”。

“These results add to the growing body of high-quality evidence demonstrating the long-term efficacy of SCS in reducing pain and improving quality of life, said Dr. Ashwini Sharan, chief medical officer of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. ”We are especially pleased that so many patients in this study not only found pain relief with Inceptiv SCS, but were also comfortable letting the closed-loop feature make stimulation adjustments automatically, lessening the burden of manual therapy changes.

“这些结果增加了越来越多的高质量证据，证明了SCS在减轻疼痛和改善生活质量方面的长期疗效，神经调节业务的首席医疗官Ashwini Sharan博士说，这是美敦力神经科学投资组合的一部分。“我们特别高兴的是，这项研究中有这么多患者不仅发现了Inceptiv SCS缓解了疼痛，而且还可以让闭环功能自动进行刺激调整，减轻了手动治疗变化的负担。

The reduced need for manual adjustments, combined with positive therapy experience and satisfaction, may lead to better therapy compliance and durability of outcomes.”.

减少对手动调整的需求，结合积极的治疗经验和满意度，可能会导致更好的治疗依从性和结果的持久性。”。

The primary and secondary study endpoints were previously met and were presented at the 2024 annual meeting of NANS. The primary endpoint was at least a 50% reduction in overstimulation with the CL feature On vs. Off at 1 month. The secondary endpoint was the proportion of patients with at least a 50% reduction in overall, back, leg or upper limb (UL) VAS scores at 3 months (88% low-back and 77% leg, 100% UL).

主要和次要研究终点先前已经达到，并在2024年NANS年会上提出。主要终点是1个月时CL功能开启与关闭时过度刺激至少减少50%。次要终点是3个月时总体，背部，腿部或上肢（UL）VAS评分至少降低50%的患者比例（88%的腰背和77%的腿部，100%的UL）。

Study subjects will have 18- and 24-month follow-up..

研究对象将进行18个月和24个月的随访。。

About Medtronic

关于美敦力

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 90,000+ passionate people across 150 countries.

大胆思考。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，延长寿命，我们将150个国家的90000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, visit .

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。有关美敦力的更多信息，请访问。