FDA批准了Dymicron公司关于颈椎人工椎间盘的研究-动脉网

FDA approves Dymicron’s study of cervical artificial disc

Medical Device Network 等信源发布 2025-07-11 10:03

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The Triadyme-C disc is engineered to replicate the natural kinematics and motion of a healthy disc. Credit: Dymicron / PRNewswire.

Triadyme-C 椎间盘被设计为复制健康椎间盘的自然运动学和运动。来源：Dymicron / PRNewswire。

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for Dymicron to initiate a pivotal trial of its Triadyme-C cervical artificial disc, a significant step towards offering a solution for individuals with degenerative disc disease.

美国食品药品监督管理局 (FDA) 已授予 Dymicron 公司研究性器械豁免 (IDE) 批准，以启动其 Triadyme-C 颈椎人工椎间盘的关键试验，这是为退行性椎间盘疾病患者提供解决方案的重要一步。

The prospective, multi-centre, historically controlled trial is set to compare the safety and effectiveness of the Triadyme-C disc against anterior cervical discectomy and fusion (ACDF) surgery in treating symptomatic cervical disc disease (SCDD).

这项前瞻性、多中心、历史对照试验将比较Triadyme-C椎间盘与前路颈椎间盘切除融合术（ACDF）在治疗症状性颈椎间盘疾病（SCDD）时的安全性和有效性。

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It will take place across various spine centres in the US, with the first implantations anticipated in the fourth quarter of this year.

它将在美国各地的多个脊柱中心进行，预计在今年第四季度进行首次植入。

The trial’s primary endpoint is composite clinical success, which is defined by improvement in the Neck Disability Index (NDI) Score and neurological status, and the absence of secondary surgical interventions.

该试验的主要终点是复合临床成功率，其定义为颈部功能障碍指数 (NDI) 评分和神经状态的改善以及没有二次手术干预。

The data collected from this trial will be instrumental in supporting a future premarket approval (PMA) submission to the agency.

从本次试验中收集的数据将对支持未来向该机构提交的上市前批准（PMA）申请起到重要作用。

Triadyme-C comprises bearing surfaces that are made from the company’s medical-grade polycrystalline diamond material called Adymite.

Triadyme-C 包含由公司生产的医疗级多晶金刚石材料 Adymite 制成的承载表面。

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This material is designed for high-stress load-bearing environments and aims to significantly decrease wear debris generation, a common issue with traditional implant materials that is associated with prolonged complications and revision surgeries.

该材料专为高应力承载环境设计，旨在显著减少传统植入材料常见的磨损颗粒产生，这些颗粒与长期并发症和翻修手术相关。

It provides Triadyme-C with hardness and low friction, tailored for the demands of spinal motion preservation.

它为Triadyme-C提供了硬度和低摩擦力，专为满足脊柱运动保留的需求而设计。

With its patented Tri-Lobe design, the system is engineered to replicate the natural kinematics and a healthy disc motion.

凭借其获得专利的三叶设计，该系统旨在复制自然运动学和健康椎间盘的运动。

Dymicron CEO and board chairman Alan Layton said: “This FDA approval is a value-defining achievement for Dymicron.

Dymicron首席执行官兼董事会主席Alan Layton表示：“此次FDA的批准对Dymicron来说是一项具有价值定义意义的成就。

“It reflects both the strength of our technology and the disciplined execution of our regulatory roadmap. We are now poised to generate high-quality clinical data that will support a future PMA [premarket approval] submission and lay the groundwork for commercialisation in the US market.”

“这既反映了我们技术的强大，也反映了我们对监管路线图的严格执行。我们现在准备生成高质量的临床数据，这些数据将支持未来的PMA（上市前批准）提交，并为在美国市场的商业化奠定基础。”

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