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Devices Orthopaedic Neurosurgery FDA

 News Release - November 30, 2010

X-spine Announces New FDA Product Clearance

The AXLE™ Interspinous Fusion System Offers New Less-Invasive Option for Spine Surgeons

MIAMISBURG, Ohio--(Healthcare Sales & Marketing Network)-- X-spine, a global manufacturer of implants and instruments for spinal surgery, announced FDA clearance of its new AXLE™ Interspinous Fusion System. The system is designed to provide spinal stability for lumbar fusion procedures, including the treatment of degenerative disk disease, spinal tumors and trauma.

The AXLE™ system incorporates a novel modular design to allow for implant customization to conform to individual patient anatomy. The implant can be placed through a one inch incision in the back with minimal disruption of tissue. The device works by rigidly attaching to the rearmost portion of adjacent vertebrae, termed the spinous process, of the lower or middle spine.

“The AXLE™ Interspinous Fusion System can be used to treat a number of prevalent spinal conditions with far less tissue disruption than traditional spinal fixation systems,” states X-spine founder and chief medical officer Dr. David Kirschman. “Today, patients and surgeons are demanding procedures that bridge the gap between non-invasive spine treatment and major procedures such as multiple level spinal fusion. The AXLE™ device addresses that demand in a manner that allows for the implanting surgeon to specifically tailor device components to achieve optimal function.” Dr. Kirschman further states, “An additional benefit of AXLE™ is that by being located on the spinous process, it is situated away from the spinal cord, spinal nerves and large blood vessels. This reduces the possibility of complications related to violation of these structures compared to traditional systems.”

The AXLE™ system is X-spine’s 10th FDA-cleared spinal implant product since 2004. It joins X-spine’s growing portfolio of spinal implant products, including the, Spider Cervical™ Plating System, the X90™ Pedicle Screw System, the Fortex™ Pedicle Screw System, the Calix™ Interbody Fixation System, the Calix ATP™ Vertebral Body Replacement System, the Fixcet™ Spinal Facet Screw System, the Butrex™ Buttress Plating System and the X-PORT™ Minimally Invasive Access System.

About X-spine:

X-spine Systems, Inc. ( is an Ohio, USA-based global developer and manufacturer of novel technologies for the surgical treatment of spinal disease. With distribution on five continents, privately-held X-spine brings advanced spinal implants and surgical instruments to surgeons and patients worldwide.

Source: X-spine Systems

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