In April 2024, the FDA granted a breakthrough device designation for Medtronic’s INFUSE Bone Graft for TLIF. Credit: Tada Images / Shutterstock.com.

2024年4月，FDA授予了美敦力公司INFUSE骨移植材料用于TLIF的突破性器械认定。 crédito: Tada Images / Shutterstock.com。

Medtronic has announced that an independent Data Monitoring Committee (DMC) reviewed the initial interim analysis and confirmed that the randomised controlled trial of INFUSE Bone Graft in the transforaminal lumbar interbody fusion (TLIF) procedure for use in spine surgery achieved predefined early success criteria..

美敦力公司宣布，独立数据监查委员会（DMC）审查了初步中期分析，并确认了INFUSE骨移植材料在经椎间孔腰椎椎体间融合术（TLIF）中用于脊柱手术的随机对照试验达到了预设的早期成功标准。

This move prompted a recommendation to suspend further participant enrolment in the trial.

这一举措促使人们建议暂停试验中进一步的参与者招募。

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The multicentre, prospective trial assessed the effectiveness and safety of INFUSE Bone Graft in TLIF procedures for those with degenerative lumbar spine conditions.

多中心前瞻性试验评估了INFUSE骨移植在退行性腰椎疾病患者TLIF手术中的有效性和安全性。

The company is currently gearing up for a premarket approval submission to the US Food and Drug Administration (FDA).

公司目前正在准备向美国食品药品监督管理局 (FDA) 提交上市前批准申请。

In April, the US regulator approved a protocol change that decreased the overall size of the sample and adopted a Bayesian adaptive design for interim endpoint analysis.

今年4月，美国监管机构批准了一项协议变更，缩小了样本的总体规模，并采用了贝叶斯自适应设计进行中期终点分析。

The trial continued assessing two dose levels of the bone graft and included both PEEK and titanium cages to enhance wider clinical relevance.

试验继续评估了骨移植的两种剂量水平，并包括了PEEK和钛笼，以增强更广泛的临床相关性。

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美国关税正在变化——你会作出反应还是提前预料？

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不要让政策变化让你措手不及。通过实时数据和专家分析保持主动性。

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In April 2024, the FDA granted a breakthrough device designation for the INFUSE Bone Graft for TLIF. This status facilitates prioritised FDA review and increased collaboration during development.

2024年4月，FDA授予INFUSE骨移植材料用于TLIF的突破性器械认定。该认定有助于加快FDA审查进度，并在开发过程中加强协作。

According to the company, TLIF is a surgical procedure that stabilises the lower back by removing a damaged disc, inserting a cage with bone graft material, and fusing adjacent vertebrae with screws and rods to relieve pain from conditions such as degenerative disc disease or disc herniation.

根据公司介绍，TLIF是一种通过移除受损椎间盘、植入含骨移植材料的笼子，并用螺钉和杆融合相邻椎骨来稳定下背部的手术程序，可缓解退行性椎间盘疾病或椎间盘突出等问题引发的疼痛。

The company also plans to apply for a New Technology Add-on Payment from the US Centers for Medicare & Medicaid Services following the PMA submission.

该公司还计划在PMA提交后，向美国医疗保险和医疗补助服务中心申请新技术附加付款。

Medtronic’s clinical, medical, regulatory affairs and health economics vice-president Dave Breiter said: “Our teams are deeply dedicated to seeing this process through to completion.

美敦力临床、医学、法规事务及健康经济学副总裁戴夫·布雷特表示：“我们的团队全力以赴，致力于将这一过程贯彻到底。

“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.”

“我们准备与FDA合作，解决PMA提交的所有方面问题，确保我们提交一份高质量的申请，符合最高标准。”

Recently, the company’s MiniMed 780G system

最近，该公司的MiniMed 780G系统

received European CE Mark approval

获得欧洲CE标志认证

to expand the indications for use to those who are aged two years and above, during pregnancy, and for those with type 2 insulin-requiring diabetes.

将适应症扩大到两岁及以上的儿童、孕妇以及需要胰岛素治疗的2型糖尿病患者。

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庆祝创新、领导力和影响力。通过参赛，您将展示您的成就，提升行业形象，并将自己置于推动医疗器械进步的顶级领导者之列。不要错过脱颖而出的机会——立即提交您的参赛作品！

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