The Inceptiv spinal cord stimulation system. [Image courtesy of Medtronic]

接收脊髓刺激系统。[图片由美敦力提供]

Medtronic

美敦力

(NYSE: MDT)

（纽约证券交易所：MDT）

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today announced 12-month data demonstrating the benefits of its Inceptiv closed-loop spinal cord stimulator (CL-SCS).

今天公布了12个月的数据，证明了其Inceptiv闭环脊髓刺激器（CL-SCS）的益处。

The clinical trial evaluated Inceptiv in patients with chronic low-back pain (CLBP) and leg pain. Medtronic plans to present data at the North American Neuromodulation Society (NANS) 2025 meeting next week in Orlando.

。美敦力计划下周在奥兰多举行的北美神经调节学会（NANS）2025会议上提交数据。

Inceptiv treats chronic pain and represents Medtronic’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the motions of daily life.

Inceptiv治疗慢性疼痛，是美敦力第一款提供闭环功能的SCS设备。这一功能感知每个人独特的生物信号，根据需要随时调整刺激。美敦力说，这可以使治疗与日常生活的运动保持协调。

The medtech giant also labeled it the world’s smallest and thinnest fully implantable SCS device.

这家医疗科技巨头还将其列为世界上最小、最薄的完全植入式SCS设备。

Medtronic won FDA approval for Inceptiv in April 2024

美敦力于2024年4月获得美国食品和药物管理局（FDA）对Inceptiv的批准

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Medtronic said its study aims to characterize the efficacy of the Inceptiv SCS system for treating chronic neuropathic pain and improving quality of life. Investigators randomized patients with closed-loop on/off periods.

美敦力表示，其研究旨在表征Inceptiv-SCS系统治疗慢性神经性疼痛和改善生活质量的功效。研究人员将患者随机分为闭环开/关期。

“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, 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、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.”

“这些结果强调了调整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。”

A look at the data from Medtronic

美敦力的数据

Findings included 93% of patients (43 subjects) reporting a reduction in overstimulation with the CL feature during in-clinic testing. Additionally, 88% preferred having the CL feature on as opposed to off. The at-home experience fell in line with in-clinic testing results with 91% (46) reporting no uncomfortable stimulation during activities of daily living..

研究结果包括93%的患者（43名受试者）报告在临床测试期间CL特征的过度刺激减少。此外，88%的人喜欢打开CL功能而不是关闭。在家的体验与临床测试结果一致，91%（46）的人报告在日常生活活动中没有不舒服的刺激。。

Medtronic said 82% of subjects reported 50% or more reduction in low-back pain intensity. They registered a mean reduction of 67%. Half of the patients (32) reduced or stopped the use of opioid medications.

美敦力表示，82%的受试者表示腰痛强度降低了50%或更多。他们平均减少了67%。一半的患者（32）减少或停止使用阿片类药物。

With the closed-loop feature on, patients only made one median adjustment to programming every 30 days. Medtronic said a comparison with a U.S. SCS market research survey across multiple manufacturers showed that 50% of those participants made frequent adjustments, at least a few times per week.

随着闭环功能的启用，患者每30天只对编程进行一次中位数调整。美敦力表示，与多家制造商的美国SCS市场研究调查相比，这些参与者中有50%经常进行调整，每周至少进行几次。

Finally, Medtronic reported 100% satisfaction with CL-SCS therapy. The company said 98% reported that they would recommend it to friends and family.

最后，美敦力报告对CL-SCS治疗100%满意。。

The study met its primary (at least a 50% reduction in overstimulation with the CL feature on vs. off at one month) and secondary (proportion of patients with at least a 50% reduction in overall, back, leg or upper limb (UL) VAS scores at 3 months) endpoints. Investigators plan for 18- and 24-month follow-up..

该研究达到了其主要（一个月时CL功能开启与关闭时过度刺激至少减少50%）和次要（总体，背部，腿部或上肢（UL）至少减少50%的患者比例）VAS评分在3个月时）终点。调查人员计划进行18个月和24个月的随访。。

“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 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.

美敦力神经调节业务首席医疗官Ashwini Sharan博士说：“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。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可以缓解疼痛，而且还可以让闭环功能自动进行刺激调整，减轻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。”。