X-spine, a global manufacturer of implants and instruments for spinal surgery, has received US Food and Drug Administration (FDA) clearance for its new Axle Interspinous Fusion System.
The Axle 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 modular design to allow for implant customisation to conform to individual patient anatomy and the implant can be placed through a one inch incision in the back with minimal disruption of tissue.
X-spine said that the device works by rigidly attaching to the rearmost portion of adjacent vertebrae, termed the spinous process, of the lower or middle spine.
X-spine founder and chief medical officer David Kirschman said the Axle device can be used to treat a number of prevalent spinal conditions with far less tissue disruption than traditional spinal fixation systems.
"The Axle device addresses the demand in a manner that allows for the implanting surgeon to specifically tailor device components to achieve optimal function," Kirschman said.
"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."