CAVUX FFS-LX Achieved 96% Fusion Rate Verified by Independent Core Imaging Lab in Recent Clinical StudyPLEASANTON, Calif., Jan. 10, 2024 /PRNewswire/ -- Providence Medical Technology, Inc. (PMT), a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S.

CAVUX FFS-LX在最近的临床研究中取得了96%的融合率，该研究由独立核心成像实验室验证。加利福尼亚州普莱桑顿，2024年1月10日/PRNewswire/--Providence Medical Technology，Inc.（PMT），一家专注于改善高危脊柱手术患者手术结果的医疗设备创新者，宣布美国。

Food and Drug Administration (FDA) has cleared its CAVUX® FFS-LX: Lumbar Facet Fixation System for use in lumbar spinal fusion surgery. .

美国食品和药物管理局（FDA）已批准其用于腰椎融合手术的CAVUX®FFS-LX：腰椎小关节固定系统。。

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CAVUX® FFS-LX (Facet Fixation System, Lumbar) is a novel integrated cage and screw system to treat lumbar degenerative disc disease that is now FDA-cleared for use in lumbar spinal fusion surgery.

CAVUX®FFS-LX（腰椎小关节固定系统）是一种新型的集成笼和螺钉系统，用于治疗腰椎退行性椎间盘疾病，现已获得FDA批准用于腰椎融合手术。

CAVUX® FFS-LX is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to treat lumbar degenerative disc disease (DDD). The implant spans the facet interspace with points of fixation at each end of the construct to offer additional stabilization for 1- or 2-level lumbar interbody fusion.

CAVUX®FFS-LX是一种新型的集成笼和螺钉系统，可双侧植入小关节以治疗腰椎退行性椎间盘疾病（DDD）。植入物跨越小关节间隙，在结构的每一端都有固定点，为1级或2级腰椎椎体间融合提供额外的稳定性。

CAVUX® FFS-LX may be used with or without pedicle screws and rods and is implanted using the company's CORUS™ Spinal System-LX tissue-sparing access and spinal fusion system..

CAVUX®FFS-LX可使用或不使用椎弓根螺钉和棒，并使用公司的康力斯植入™ 脊柱系统LX组织保留通路和脊柱融合系统。。

The clearance marks the company's expansion into the $2 billion lumbar spine market characterized by a higher surgical failure rate than in the cervical spine. Patients who fail to fuse after a lumbar spine fusion surgery face a substantial risk of added complications, suffering, and costly revision procedures.

该许可标志着该公司向价值20亿美元的腰椎市场扩张，其特点是手术失败率高于颈椎。腰椎融合手术后未能融合的患者面临着增加并发症，痛苦和昂贵的翻修手术的巨大风险。

CAVUX® FFS-LX was designed to offer increased stabilization following lumbar fusion procedures in order to increase fusion rates and reduce future complications and reoperations. .

CAVUX®FFS-LX旨在提高腰椎融合手术后的稳定性，以提高融合率，减少未来的并发症和再次手术。。

The clearance was supported by clinical study data demonstrating a strong safety and efficacy profile. Summary clinical study data reviewed by the FDA in considering the clearance included:

临床研究数据证明了这种清除率具有很强的安全性和有效性。总结FDA在考虑清除率时审查的临床研究数据包括：

57 patients were evaluated with a median follow-up of 30 months. The median age was 45, the median body mass index was 30, and 68% of subjects reported nicotine use as a risk factor.

57名患者接受了中位随访30个月的评估。中位年龄为45岁，中位体重指数为30，68%的受试者报告尼古丁使用是危险因素。

96% of levels were determined to be fused as defined by a range of motion less than 5° on flexion/extension x-rays assessed by an independent core imaging lab.

根据独立核心成像实验室评估的屈曲/伸展x射线运动范围小于5°的定义，确定96%的水平融合。

Clinically meaningful improvement in pain was achieved in 79% of subjects.

79%的受试者取得了临床上有意义的疼痛改善。

'At Providence, we are driven to improve clinical outcomes and prevent surgical failures for high-risk patients,' commented Jeff Smith, Co-founder and CEO of Providence Medical Technology. 'CAVUX® FFS-LX builds off our successful cervical platform and applies the same principles to the lumbar spine where the challenge of treating high-risk patients is even more pronounced.

普罗维登斯医疗技术公司联合创始人兼首席执行官杰夫·史密斯（Jeff Smith）评论道：“在普罗维登斯，我们致力于改善临床结果，防止高危患者的手术失败。”CAVUX®FFS-LX建立了我们成功的颈椎平台，并将相同的原理应用于腰椎，在腰椎治疗高危患者的挑战更为明显。

We are excited to be launching into the lumbar market and provide high-risk patients a new option for a fusion success.'Joseph O'Brien, MD, a leading orthopedic spine surgeon specializing in minimally invasive spine surgery, and founder of the Washington Spine and Scoliosis Institute commented, 'I am excited about the FDA clearance of CAVUX FFS-LX as a treatment option for patients treated with lumbar fusion for degenerative disc disease.

我们很高兴能够进入腰椎市场，为高危患者提供融合成功的新选择。”约瑟夫·奥布莱恩（JosephO'Brien）医学博士是一位专门从事微创脊柱手术的领先骨科脊柱外科医生，也是华盛顿脊柱和脊柱侧弯研究所（Washington spine and Scoliosis Institute）的创始人，他评论道：“我对FDA批准CAVUX FFS-LX作为腰椎间盘退行性疾病融合患者的治疗选择感到兴奋。

The implant provides increased stabilization at the lumbar facet level for minimally invasive fusion procedures. This new option will expand the spine specialist's treatment arsenal and likely lead to increased fusion rates for patients. I have seen excellent results from this technology in challenging fusion patients.'For more information and full product indications visit providencemt.com/products-cavux-ffs-lx/About Providence Medical Technology, Inc.Providence Medical Technology, Inc.

该植入物在腰椎小关节水平为微创融合手术提供了更高的稳定性。这一新选择将扩大脊柱专家的治疗范围，并可能提高患者的融合率。我已经看到这项技术在挑战融合患者方面取得了出色的效果。”有关更多信息和完整的产品适应症，请访问providencemt.com/products-cavux-ffs-lx/About Providence Medical Technology，Inc.Providence Medical Technology，Inc。

is a leading medical device company focused on advancing spine surgery technologies. Its commitment to improving clinical outcomes and reducing failures in high-risk spinal surgery has led PMT to be at the forefront of developing innovative solutions like CAVUX® FFS-LX. The company's comprehensive range of products, including CORUS™ Spinal Systems, CAVUX® Facet Fixation Systems, and ALLY® Bone Screws and Facet Screws underscores its dedication to excellence in spinal care.SOURCE Prov.

是一家领先的医疗器械公司，专注于推进脊柱手术技术。它致力于改善临床结果和减少高风险脊柱手术失败，这使PMT在开发CAVUX®FFS-LX等创新解决方案方面处于领先地位。该公司的产品范围广泛，包括康力斯™ 脊柱系统，CAVUX®小关节固定系统，以及ALLY®骨螺钉和小关节螺钉强调了其在脊柱护理方面的卓越贡献。来源证明。