FDA clears X-spine's Axle fusion system
This article was originally published in Clinica
Executive Summary
The Axle interspinous fusion system developed by X-spine has received 510(k) clearance from the US FDA. The system is designed to provide spinal stability, aiding lumbar fusion, and may be used in the treatment of degenerative disc disease, spinal tumours and trauma. The device causes "far less tissue disruption than traditional spinal fixation systems" according to the Miamisburg, Ohio firm, as it can be implanted through a one-inch incision in the patient's back. The Axle system attaches to the spinous process – the rearmost portion of adjacent vertebrae – of the lower or middle spine. This means that it is away from the spinal cord, spinal nerves and large blood vessels, reducing the possibility of complications.
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