MIAMISBURG, Ohio--(BUSINESS WIRE)--X-spine, a global manufacturer of implants and instruments for spinal surgery, announced it has received the CE Mark for its AXLE™ Interspinous Fusion System. The device, which was launched in the USA earlier this year, is designed to provide spinal stability for 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 is placed through a small incision with minimal disruption of tissue and rigidly attaches to the rearmost portion of adjacent vertebrae, termed the spinous process, of the lower or middle spine. The AXLE™ system is designed to reduce implant volume, decrease incision size and reduce operative time compared to traditional fusion systems. Furthermore, AXLE™ is placed a distance from critical nerves, blood vessels, and abdominal structures compared to other systems. The AXLE™ device is intended to bridge the gap between non-instrumented spinal procedures and larger reconstructive fusion surgeries.
The AXLE™ CE Mark expands X-spine’s global product footprint and will be distributed in Europe through its Netherlands facility. “Gaining a CE Mark for AXLE™ gives us the opportunity to put this valuable technology into the hands of surgeons in Europe and broader international markets,” states X-spine founder and CEO David Kirschman, M.D. “The AXLE™ launch has been tremendously successful in the USA and we are excited about expanding that success worldwide.”
About X-spine
X-spine Systems, Inc. is a global developer and manufacturer of spinal implant and instrumentation systems. X-spine’s product line includes core spinal products and novel technologies for the treatment of spinal disease. The company serves markets in the USA, Europe, Middle East, Africa, and Australia.
X-spine’s product portfolio includes the AXLE™ Interspinous Fusion System, 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.