X-spine Announces CE Mark For AXLE™ Interspinous Fusion System
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."
X-spine Systems, Inc.
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