Medtronic, a global leader in healthcare technology, has announced a significant milestone in its INFUSE™ Bone Graft for TLIF Investigational Device Exemption (IDE) Study, a randomized controlled trial of INFUSE™ Bone Graft in the Transforaminal Lumbar Interbody Fusion (TLIF) procedure used in spine surgery.

全球医疗技术领导者美敦力公司宣布其在INFUSE™骨移植TLIF（经椎间孔腰椎椎间融合术）试验性器械豁免（IDE）研究中取得了重要里程碑，这是一项关于在脊柱手术中使用的经椎间孔腰椎椎间融合术（TLIF）中应用INFUSE™骨移植的随机对照试验。

Following the first interim analysis, the independent Data Monitoring Committee (DMC) determined that the study met the predefined criteria for early success. Based on this assessment, the DMC recommended stopping further enrollment. Medtronic is now in the process of preparing a Premarket Approval (PMA) submission to the U.S.

在第一次中期分析之后，独立的数据监测委员会（DMC）确定该研究达到了预先设定的早期成功标准。基于这一评估，DMC建议停止进一步招募患者。美敦力公司现在正准备向美国提交上市前批准（PMA）申请。

Food and Drug Administration (FDA)..

食品药品监督管理局 (FDA)。

Study overview and protocol amendment

研究概况与协议修正案

The INFUSE™ Bone Graft for TLIF study is a prospective, multicenter, randomized controlled trial conducted under an IDE. The study is designed to evaluate the safety and effectiveness of INFUSE™ Bone Graft in TLIF procedures for patients with degenerative lumbar spine conditions. In April 2025, FDA approved a protocol amendment which reduced the overall sample size and introduced a Bayesian adaptive design to enable interim analysis of study endpoints.

INFUSE™骨移植TLIF研究是一项在IDE（研究器械豁免）下进行的前瞻性、多中心、随机对照试验。该研究旨在评估INFUSE™骨移植在退行性腰椎疾病患者TLIF（经椎间孔腰椎间融合术）中的安全性和有效性。2025年4月，FDA批准了一项协议修正案，减少了总体样本量，并引入了贝叶斯适应性设计，以实现对研究终点的中期分析。

The study design continued the evaluation of two dose levels of INFUSE™ Bone Graft and incorporated both PEEK and titanium cages to support broader clinical applicability..

研究设计继续评估两种剂量水平的INFUSE™骨移植，并结合了PEEK和钛笼，以支持更广泛的临床适用性。

Breakthrough designation accelerates progress

突破性指定加速进展

INFUSE™ Bone Graft for the TLIF indication received Breakthrough Device Designation from the FDA in April 2024. This designation is intended for devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions and that represent breakthrough technologies or offer significant advantages over existing alternatives.

INFUSE™ 骨移植材料用于TLIF适应症在2024年4月获得了FDA的突破性设备认定。该认定适用于那些有可能为危及生命或不可逆衰弱性疾病提供更有效治疗或诊断的设备，并且代表了突破性技术或相较于现有替代方案具有显著优势。

The designation supports prioritized review and enhanced interaction with the FDA throughout the development and regulatory process..

该指定支持在开发和监管过程中优先审查并与 FDA 加强互动。

Advancing spine care

推进脊柱护理

This potential new indication for INFUSE™ Bone Graft could expand treatment options for spine surgery patients if approved. TLIF is a spinal fusion procedure used to stabilize the lower back and alleviate pain caused by degenerative disc disease or disc herniation. It involves removing a damaged disc, placing a spacer (cage) with bone graft material, and using screws and rods to fuse the adjacent vertebrae..

如果获得批准，INFUSE™骨移植的这一潜在新适应症可能会扩大脊柱手术患者的治疗选择。TLIF是一种用于稳定下背部并缓解由退行性椎间盘疾病或椎间盘突出引起的疼痛的脊柱融合术。该手术包括移除受损的椎间盘，放置带有骨移植材料的间隔物（笼子），并使用螺钉和杆将相邻的椎体融合。

What’s Next

接下来是什么

While this milestone is a significant achievement, there is still work to be done to make INFUSE™ Bone Graft for TLIF commercially available. The FDA PMA process requires rigorous evaluation to ensure the safety and effectiveness of the product. Medtronic is fully committed to navigating this process with speed, efficiency, and accuracy.

虽然这一里程碑是一项重大成就，但要使INFUSE™骨移植材料用于TLIF术式商业化可用，仍有工作要做。FDA的PMA流程要求严格的评估，以确保产品的安全性和有效性。美敦力完全致力于以快速、高效和准确的方式完成这一过程。

The study’s innovative design, which includes a diverse dataset with contributions from international patients, represents a unique opportunity to demonstrate the broad applicability of INFUSE™ Bone Graft for TLIF..

该研究的创新设计包括来自国际患者的多样化数据集，这为证明INFUSE™骨移植材料在TLIF中的广泛应用提供了一个独特的机会。

“Our teams are deeply dedicated to seeing this process through to completion,” said Dave Breiter, vice president of Clinical, Medical, Regulatory Affairs and Health Economics for the Cranial & Spinal Technologies business, which is part of the Neuroscience Portfolio at Medtronic. “We are prepared to work collaboratively with the FDA to address all aspects of the PMA submission and ensure we deliver a high-quality application that meets the highest standards.”.

“我们的团队全力以赴，致力于将这一过程贯彻到底，”美敦力神经科学产品组合中颅骨和脊柱技术业务的临床、医学、监管事务及卫生经济学副总裁戴夫·布赖特表示，“我们准备与FDA合作，解决PMA提交的所有方面问题，确保提交一份高质量的申请，达到最高标准。”

Medtronic remains steadfast in its mission to bring this transformative technology to patients as quickly and responsibly as possible. The company is also preparing to file for New Technology Add-on Payment (NTAP) with the U.S. Centers for Medicare & Medicaid Services (CMS) shortly after submitting the PMA, further enhancing the economic value of this innovation for payers and providers..

美敦力仍坚定地致力于以最快且最负责任的方式将这项变革性技术带给患者。该公司还准备在提交PMA后不久向美国医疗保险和医疗补助服务中心 (CMS) 申请新技术附加支付 (NTAP)，进一步提升这项创新对支付方和提供方的经济价值。

About the Cranial & Spinal Technologies Business at Medtronic

关于美敦力的颅脊髓技术业务

As the global market leader, Medtronic Cranial and Spinal Technologies is transforming the standard of care in spine and cranial surgery by putting patients first and addressing the complex challenges faced by spine and neurosurgeons. With a portfolio of 150 products covering more than 20 pathologies, we serve over 4 million patients annually.

作为全球市场领导者，美敦力颅脑和脊柱技术公司通过将患者放在首位并解决脊柱和神经外科医生面临的复杂挑战，正在改变脊柱和颅脑手术的护理标准。我们拥有涵盖 20 多种病理的 150 种产品组合，每年为超过 400 万名患者提供服务。

Building on a legacy of innovation, our AiBLE™ ecosystem integrates advanced technologies, data and AI with a patient-centric approach, offering customizable solutions to enhance surgical precision, improve workflow efficiency, and achieve better outcomes, before, during and beyond surgery..

基于创新的传统，我们的AiBLE™生态系统以患者为中心，整合了先进技术、数据和人工智能，提供可定制的解决方案，以提高手术精度、改善工作流程效率，并在手术前、中、后实现更好的结果。

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 95,000+ passionate people across more than 150 countries.

大胆思考。更大胆的行动。我们是美敦力。美敦力公司总部位于爱尔兰戈尔韦，是全球领先的医疗技术公司，通过寻找和发现解决方案，勇敢地应对人类面临的最具挑战性的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

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, visit .

随着我们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，请对我们有更多期待。在我们所做的每一件事中，我们都在创造非凡。欲了解有关美敦力的更多信息，请访问。