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Life Spine宣布ProLift®枢轴可扩展间隔系统获得FDA 510(k)批准

Life Spine Announces FDA 510(k) Clearance for the ProLift ® Pivot Expandable Spacer System

businesswire 等信源发布 2025-01-29 23:31

可切换为仅中文


HUNTLEY, Ill.--(

伊利诺伊州亨特利--(

BUSINESS WIRE

商业热线

)--Life Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the ProLift Pivot Expandable Spacer System.

)--。

The ProLift Pivot System represents the latest innovation in Life Spine’s Micro Invasive™ technology portfolio, combining full articulation capability with a patient-centered approach to spinal fusion procedures. Designed to provide superior control while minimizing tissue disruption and nerve retraction, the system supports surgeons in restoring patient alignment with great precision and efficiency..

ProLift Pivot系统代表了Life Spine微创™技术组合的最新创新,将全关节功能与以患者为中心的脊柱融合手术方法相结合。该系统旨在提供卓越的控制,同时最大程度地减少组织破坏和神经回缩,支持外科医生以极高的精度和效率恢复患者对齐。。

Features and Benefits of the ProLift Pivot System:

ProLift Pivot系统的功能和优点:

Advanced Technology:

先进技术:

In-situ expansion up to 5mm to optimize alignment

原位扩展至5mm以优化对齐

• Ability to collapse and expand for precise repositioning

•能够折叠和扩展以精确重新定位

• Full articulation capability for optimal anterior placement

•完整的关节功能,实现最佳的前部位置

Streamlined Design:

流线型设计:

Bulleted tip for simplified insertion

项目符号尖端简化插入

• Reduced instrument passes for increased surgical efficiency

•减少器械通过次数,提高手术效率

• In-situ graft delivery for seamless procedural integration

•原位移植物输送,实现无缝程序整合

Patient-Focused Outcomes:

以患者为中心的结果:

Designed to restore normal physiologic alignment

旨在恢复正常的生理对齐

• Visual and tactile confirmation mechanisms to prevent over-distraction

•视觉和触觉确认机制,以防止过度分心

• Streamlined instrumentation for reliable and straightforward procedures

•简化仪器,实现可靠而直接的程序

“Receiving FDA clearance for the ProLift Pivot Expandable Spacer System is a significant milestone for Life Spine and underscores our commitment to advancing Micro Invasive™ technology,” said Rich Mueller, Chief Operating Officer. “This innovative system empowers surgeons with enhanced control, full articulation capabilities, while also prioritizing patient outcomes and recovery times.”.

首席运营官Rich Mueller表示:“ProLift Pivot可扩展垫片系统获得FDA批准,这是Life Spine的一个重要里程碑,突显了我们致力于推进微创™技术。”。“这一创新系统使外科医生能够增强控制能力,全面的发音能力,同时优先考虑患者的预后和恢复时间。”。

The ProLift Pivot System also features OSSEO-LOC

ProLift Pivot系统还具有OSSEO-LOC功能

®

®

Surface Technology, designed to promote osseointegration and long-term implant stability. By combining advanced engineering and streamlined instrumentation, Life Spine continues to set new standards in minimally invasive spinal fusion procedures.

表面技术,旨在促进骨整合和长期种植体稳定性。通过结合先进的工程和简化的仪器,Life Spine继续在微创脊柱融合手术中设定新标准。

About Life Spine, Inc.

关于Life Spine,Inc。

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois.

Life Spine致力于通过创新设计、不妥协的质量标准和最先进的技术制造平台,提高手术效率和疗效,从而提高脊柱患者的生活质量。Life Spine是一家私营公司,总部位于伊利诺伊州亨特利。

For more information, please visit: .

有关更多信息,请访问:。

http://www.lifespine.com

http://www.lifespine.com

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