October 29, 2012
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FDA approves expanded indications for anterior lumbar interbody fusion device

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Integra LifeSciences Holdings Corporation has announced FDA approval of an expanded indication for use of the Integra Vu aPOD Prime Intervertebral Body Fusion Device in anterior lumbar interbody fusion procedures.

According to a company press release, the new stand-alone indication includes four points of fixation, which is composed of two screws and a SpinPlate. Featuring two zero-profile options utilizing two screws or two screws and a SpinPlate to help secure the intervertebral body fusion device in its functional position, the device eliminates the need for supplemental fixation implants and reduces the number of steps and implants required to perform an anterior lumbar interbody fusion procedure.

Earlier this year the Vu aPOD Prime IBD entered its full market release with stand-alone indications,” Kirt Stephenson, president of US Spine, stated in the release. “We’re pleased that with this additional indication, we can now provide surgeons with multiple fixation options to best meet their patients' needs.