GENEVA, March 8, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, today announced it has completed enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with cervical disc disease at two contiguous levels between C3 to C7 compared to a commercially marketed cervical disc implant..

日内瓦，2024年3月8日/PRNewswire/--BAGUERA®C颈椎间盘假体制造商Spineart SA今天宣布，它已经完成了其美国IDE试验的注册，该试验研究了颈椎间盘疾病患者的BAGUERA®C颈椎间盘假体在C3至C7之间的两个连续水平，与市售颈椎间盘植入物相比。。

The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint of the study is the clinical success rate of BAGUERA®C in two contiguous levels from C3 to C7 compared with two-level cervical disc replacement with a commercially available disc replacement implant.

这项多中心前瞻性随机对照试验在美国25个地点招募了300多名患者。该研究的主要终点是BAGUERA®C在C3至C7的两个连续水平上的临床成功率，与使用市售椎间盘置换植入物的两级颈椎间盘置换相比。

The Company announced the completion of enrollment for its one-level IDE trial at the end of February 2024..

该公司宣布于2024年2月底完成其一级IDE试用的注册。。

Jerome Trividic, CEO of Spineart, said, 'The enrollment completion of our two-level BAGUERA®C IDE study marks a significant milestone in Spineart's ambition to emerge as a global leader in spine arthroplasty. Coupled with the ongoing one-level BAGUERA®C IDE study, Spineart is spearheading the gathering of crucial long-term clinical evidence from nearly 600 artificial disc recipients across the United States.

Spineart首席执行官杰罗姆·特里维迪奇（JeromeTrividic）表示，“我们两级BAGUERA®C IDE研究的注册完成标志着Spineart成为脊柱关节成形术全球领导者的雄心壮志的一个重要里程碑。结合正在进行的一级BAGUERA®C IDE研究，Spineart正在带头收集来自美国近600名人工椎间盘接受者的关键长期临床证据。

This unprecedented achievement underscores our commitment to advancing the adoption of cutting-edge technologies in spinal surgery. We extend our sincere gratitude to our esteemed investigators and their teams whose dedicated participation has been instrumental in this endeavor. We eagerly anticipate bringing these two studies to fruition.'.

这一前所未有的成就突显了我们致力于推动脊柱外科采用尖端技术。我们衷心感谢我们尊敬的调查人员及其团队，他们的敬业参与有助于这项工作。我们热切期待这两项研究取得成果。”。

Domagoj Coric, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, NC, and co-lead investigator of the IDE trials, stated, 'The outcomes from this study will further build the level I evidence supporting the safety and effectiveness of cervical disc arthroplasty with its head-to-head comparison against another cervical implant with similar design features.'.

北卡罗来纳州夏洛特市Carolina Neurosurgery＆Spine Associates的神经外科医生Domagoj Coric和IDE试验的联合首席研究员表示，“这项研究的结果将进一步建立I级证据，支持颈椎间盘置换术的安全性和有效性，并与另一种具有类似设计特征的颈椎植入物进行头对头比较。”。

The BAGUERA®C Cervical Disc prosthesis is evaluated in two separate IDE trials in the U.S. for one- and two-level cervical disc disease. The BAGUERA®C implant has been commercially available in selected European and worldwide markets since 2008. Internationally, early long-term feedback has shown substantial improvement in patient pain scores and functional improvement after treatment..

BAGUERA®C颈椎间盘假体在美国的两项单独的IDE试验中针对一级和二级颈椎间盘疾病进行了评估。自2008年以来，BAGUERA®C植入物已在选定的欧洲和全球市场上上市。在国际上，早期的长期反馈显示患者疼痛评分和治疗后功能改善显着改善。。

BAGUERA®C CERVICAL DISC PROSTHESIS

BAGUERA®C颈椎间盘假体

The BAGUERA®C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA®C is designed to maintain the natural behavior of a functional spinal unit.

由Spineart SA（瑞士日内瓦）开发的BAGUERA®C颈椎间盘假体是一种研究装置，旨在维持或恢复症状性颈椎间盘疾病单节段或两节段椎间盘切除术后脊柱颈椎区域的节段运动和椎间盘高度。BAGUERA®C旨在维持功能性脊柱单元的自然行为。

This design enables the BAGUERA®C nucleus to move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) along with independent translational motions (anterior-posterior and lateral translations)..

这种设计使BAGUERA®C核能够在所有六个自由度中移动，具有独立的角度旋转（屈伸，侧向弯曲和轴向旋转）以及独立的平移运动（前后和侧向平移）。。

SPINEART

SPINEART

Spineart's mission is to transform spine surgery for patients, surgeons, and hospitals by developing procedures and medical devices that are safe and efficient, used by surgeons to enhance their patient's life. True to its values: Quality, Innovation, Simplicity, Spineart is renowned as a pioneer in the fields of disc prosthesis, simplification of surgical acts, 3D printed porous titanium and traceability of surgical implants.

Spineart的使命是通过开发安全高效的程序和医疗设备，为患者、外科医生和医院改造脊柱手术，外科医生使用这些程序和设备来改善患者的生活。凭借其价值观：质量、创新、简单，Spineart在椎间盘假体、简化手术行为、3D打印多孔钛和外科植入物可追溯性领域享有盛誉。

Today, Spineart remains at the forefront of its sector with the development of a complete portfolio of procedural solutions and digital technologies for surgical assistance. Spineart was awarded the 'Prix de l'Economie Genevoise 2022' for its contribution to technological and scientific innovations, commercial activities, job creations and ESG principles.

今天，Spineart仍然处于其行业的前沿，开发了完整的手术解决方案和数字技术组合，用于手术辅助。Spineart因其在技术和科学创新、商业活动、创造就业机会和ESG原则方面的贡献而被授予“2022年经济学奖”。

Please visit www.spineart.com and follow us on Linkedin (Spineart).

请访问www.spineart.com并在Linkedin（spineart）上关注我们。

SOURCE Spineart

源Spineart