X-spine gets FDA clearance for Axle Interspinous Fusion System


X-spine 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 disc disease, spinal tumours and trauma.

The Axle system incorporates a novel modular design to allow for implant customisation 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 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.” 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.