LDR Announces FDA Clearance Of Its ROI-A™ ALIF Device

Main Category: Neurology / Neuroscience
Also Included In: Medical Devices / Diagnostics
Article Date: 06 Apr 2009 - 2:00 PDT

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LDR, a total spine solution company, announced that it received FDA clearance on Feb. 2 to market its ROI-A™ implant as an anterior lumbar interbody fusion (ALIF) device. Previously cleared in April 2008 as a partial vertebral body replacement, the ROI-A™ system incorporates the innovative VerteBRIDGE™ screwless plating technology.

The ROI-A™ ALIF is a stand-alone implant system with zero profile, self-locking plates designed for initial and long-term stability. The surgical technique is a direct anterior approach, with the curved plates inserted along the sagittal plane thus requiring no additional exposure to the vertebral bodies.

The ROI-A™ ALIF device is made of PEEK-Optima® for biocompatibility and radiolucency along with Tantalum markers for verification of implant positioning. The system is comprised of multiple footprint sizes, lordotic angles and heights for optimized fit per anatomical requirements. An innovative inserter holds the implant, protecting vascular structures and guiding the plates during insertion.

Christophe Lavigne, CEO of LDR, comments, "Since launching the system in the United States in 2008, close to 500 of the ROI-A devices have been implanted with extremely positive feedback from the surgeons. We are very optimistic about the future of this device for ALIF procedures."

LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at http://www.ldrholding.com.

Source
LDR

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