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X-spine Announces FDA Clearance of New Spinal Implant System



5/7/2013 7:15:14 AM

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MIAMISBURG, Ohio--(BUSINESS WIRE)-- X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces a new USFDA clearance for the Zygafix™ Facet Fusion System. The newly-cleared Zygafix™ system allows for fusion and stabilization of the facet joint (also termed the zygapophyseal joint) in eligible patients whom appropriate non-surgical treatment has failed. The device can be placed through a minimally-invasive approach, and incorporates a hollow fenestrated titanium compression screw with internal bone graft in order to achieve a solid fusion.

Unlike intra-facet systems which simply consist of a solid bone implant wedged into the facet joint which do not provide mechanical fixation, the Zygafix™ is a true fixation system incorporating a titanium compression screw. The implant is packed with bone graft and creates a fusion mass across the facet joint and imparts long-term stability. The implant and instrumentation suite allows for either open or minimally-invasive exposure. Additionally, the implant can be placed through a simple trans-facet approach in addition to typical facet approaches.

“Facet systems are continuing to gain in popularity as a less-invasive alternative to pedicle screws for posterior spinal stabilization,” states David Kirschman M.D., a former spine surgeon and President and CEO of X-spine. “The Zygafix™ system is unique in that it allows for both direct bone grafting and mechanical screw fixation of the facet joint within a single implant through a minimally invasive approach.”

The Zygafix™ joins the previously cleared X-spine Fixcet™ traditional solid facet screw system to give surgeons a choice in facet systems to appropriately address individual pathologies. The Zygafix™ system, in addition to the previously-cleared AXLE™ and SILEX™ systems, completes X-spine’s product triad of novel devices to treat the emerging spinal fusion sites available to today’s spine surgeon: interspinous, sacroiliac, and transfacet.

The Zygafix™ Facet Fusion System joins X-spine’s continually expanding portfolio of innovative spinal devices, including the SILEX™ SI Joint Fusion System , AXLE™ Interspinous Fusion System, CERTEX™ Cervico-thoracic Fixation System, the CALIX PC™ Titanium-coated Intervertebral Fusion System, the FIXCET™ Facet Fixation System, the FORTEX™ and X90™ Pedicle Screw Systems, the SPIDER™ Cervical Plating System, and the HGRAFT™ Spinal Allograft System. Privately-held X-spine Systems, Inc. (www.x-spine.com) designs and manufactures surgical implants and instrumentation for use in spinal surgery. Headquartered in Ohio , X-spine brings its philosophy of inventive products, simplicity of design, and intuitive function to spine surgeons and patients worldwide.

Contact:

X-spine Systems, Inc.

Daniel Abromowitz, Sales and Marketing Director, 1-800-903-0640



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