DUBLIN, April 26, 2024 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life..

都柏林，2024年4月26日/PRNewswire/--医疗保健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，美国食品和药物管理局（FDA）已批准Inceptiv™闭环可充电脊髓刺激器（SCS）用于治疗慢性疼痛。Inceptiv是第一款美敦力SCS设备，提供闭环功能，可感知脊髓沿线的生物信号，并实时自动调整刺激，使治疗与日常生活的运动保持一致。。

'Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment,' said Dr. Krishnan Chakravarthy, M.D., Ph.D., Director of Innovative Pain Treatment Solutions and Surgery Center, VA San Diego Healthcare, and Chairman of the Empower You Chronic Pain Foundation.

弗吉尼亚州圣地亚哥医疗保健创新疼痛治疗解决方案和手术中心主任、Empower You慢性疼痛基金会主席、医学博士Krishnan Chakravarthy博士说：“疼痛是非常个人化的，刺激疗法应该时刻满足每个患者的需求。”。

'Inceptiv listens to what the body is saying and, more quickly than you can blink, it seamlessly adjusts. This represents an important leap forward for the treatment of chronic pain.'.

“Inceptiv倾听身体的声音，比你眨眼的速度更快，它可以无缝地进行调整。这是治疗慢性疼痛的一个重要飞跃。”。

Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain. As patients go about their daily lives, certain movements such as laughing, bending, or sneezing may result in brief moments of uncomfortable overstimulation. This in turn may lead some patients to turn down their device's stimulation output, resulting in a suboptimal therapy experience..

传统的固定输出SCS设备提供恒定、温和的电脉冲，在疼痛信号到达大脑之前破坏疼痛信号。随着患者日常生活的进行，某些动作（如大笑、弯腰或打喷嚏）可能会导致短暂的不适过度刺激。这反过来可能会导致一些患者降低设备的刺激输出，从而导致不理想的治疗体验。。

By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician's prescribed stimulation that is tailored to a patient's needs. Specialized circuitry and a proprietary algorithm detect ECAPs (Evoked Compound Action Potentials), signals generated by the spinal cord in response to electrical stimuli.

相比之下，Inceptiv SCS感知生物信号，并始终保持医生根据患者需求量身定制的处方刺激。专门的电路和专有算法检测ECAP（诱发复合动作电位），即脊髓响应电刺激产生的信号。

ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body's response to stimulation† 50 times per second and instantly increases or decreases stimulation to maintain prescribed settings as determined by the physician..

ECAP是脊髓中激活多少神经组织的直接量度，可用于实时调整刺激。接收SCS每秒感知身体对刺激的反应†50次，并立即增加或减少刺激，以维持医生确定的规定设置。。

The Inceptiv system delivers additional advantages beyond its closed-loop capability. Inceptiv offers unparalleled access to diagnostic imaging, with 1.5T and 3T full-body MRI access with no power or impedance restrictions.‡ It is the only FDA-approved closed-loop spinal cord stimulator that offers full-body 3T MRI access.

Inceptiv系统提供了超出其闭环能力的其他优势。Inceptiv提供无与伦比的诊断成像，1.5T和3T全身MRI访问，无电源或阻抗限制它是FDA批准的唯一一款提供全身3T MRI通路的闭环脊髓刺激器。

Up to 84% of SCS-implanted patients are expected to need at least one MRI within five years of implant.1 It is the world's smallest and thinnest fully implantable SCS device, designed for patient comfort. In addition, Inceptiv SCS allows the option of multiple types of waveforms, including Medtronic's proprietary DTM™ SCS therapy, which demonstrated an 84% responder rate at 12 months in a large, multicenter randomized controlled trial (RCT).2,3 Patients with Inceptiv SCS can also access CareGuidePro™, a mobile application and web portal that serves as a virtual guide throughout their Medtronic spinal cord stimulation therapy journey..

预计高达84%的植入SCS的患者在植入后五年内至少需要一次MRI。1它是世界上最小和最薄的完全可植入SCS设备，专为患者舒适而设计。此外，Inceptiv-SCS允许选择多种类型的波形，包括美敦力专有的DTM™SCS治疗，在一项大型多中心随机对照试验（RCT）中，12个月时有84%的应答率。2,3 Inceptiv-SCS患者还可以访问CareGuidePro™，这是一种移动应用程序和门户网站，在美敦力脊髓刺激治疗过程中起着虚拟指南的作用。。

'A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront,' said David Carr, vice president and general manager, Pain Interventions within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. 'For patients dealing with chronic pain, every day is a struggle.

“脊髓刺激技术的新时代正在开始，凭借Inceptiv SCS，美敦力走在了最前沿，”神经调节业务疼痛干预副总裁兼总经理大卫·卡尔（DavidCarr）说，这是美敦力神经科学投资组合的一部分对于患有慢性疼痛的患者来说，每天都是一场斗争。

They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS.'.

他们应该得到个性化和有效的缓解，而不影响未来对MRI的访问。他们应该得到市场上最小和最薄的设备所能提供的舒适感。我们很自豪能通过Inceptiv SCS提供当今最前沿的解决方案。”。

Medtronic will initiate the U.S. market launch of Inceptiv in the coming weeks. The system previously earned approvals for sale in Europe and in Japan. For more information, visit Medtronic.com/Inceptiv.

美敦力将在未来几周在美国市场推出Inceptiv。该系统之前已获得欧洲和日本的销售许可。有关更多信息，请访问Medtronic.com/Inceptiv。

† Sensing signals may not be measurable in all cases

†并非在所有情况下都可以测量传感信号

‡ Under certain conditions. Refer to product labeling for full list of conditions.

‡在某些条件下。有关条件的完整列表，请参阅产品标签。

About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 150 countries.

关于美敦力思维。更大胆的行动。我们是美敦力。总部位于爱尔兰都柏林的美敦力公司（Medtronic plc）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，我们团结了150个国家的95000多名充满激情的全球团队。