X-spine Gets FDA Clearance of New Spinal Fusion System

MIAMISBURG, Ohio--(BUSINESS WIRE)-- X-spine, an emerging leader in the design of devices for the treatment of spine disease, today announced FDA clearance of the AXLE™-PEEK Interspinous Fusion System. The AXLE-PEEK system consists of spinal implants FDA-cleared for the treatment of degenerative disk disease (DDD). The system expands on X-spine’s AXLE™ line of interspinous fusion devices by incorporating an insert manufactured from PEEK-OPTIMA® provided by Invibio Biomaterial Solutions. The AXLE-PEEK implants can be placed through a smaller incision and with less disruption of tissues than traditional spinal fusion devices. With this clearance, X-spine uniquely offers spine surgeons a choice of implant materials, either titanium or polymer, in a single device.

“The proprietary modular design of the AXLE system allows for different types of inserts to be placed in the interspinous space. Surgeons can now decide if polymer or titanium is the best choice for their specific needs and indications,” states Dr. David Kirschman, President and CEO of X-spine. “This type of innovation exemplifies our philosophy of putting multiple treatment options into the hands of the spine surgeon and patient.”

The AXLE™-PEEK Interspinous Fusion System joins X-spine’s expanding portfolio of innovative spinal devices, including the Calix™/Calix PC™ Intervertebral Fusion Systems, the FIXCET™ Facet Fixation System, the BUTREX™ Buttress Plating System, the FORTEX™ and X90™ Pedicle Screw Systems, the SPIDER™ Cervical Plating System, and the HGRAFT™ Spinal Allograft System. All X-spine implants are made in the USA.

About X-spine

X-spine (www.x-spine.com) is a developer and manufacturer of advanced, proprietary implants and instrumentation for surgery of the spine. Based in Ohio, the privately-held company manufactures and markets products worldwide for the surgical treatment of a broad range of spinal pathologies.

About Invibio

Invibio is a global leader providing high performance biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets. The company provides medical device manufacturers with PEEK-OPTIMA® polymer and compounds, MOTIS® polymer, ENDOLIGN® composite and PEEK-CLASSIX® polymer for the development of long- and short-term implantable medical devices.

Contact:

X-spine Systems, Inc.

Daniel Abromowitz, 937-847-8400

800-903-0640

OR

Invibio

+484 342 6004 (U.S.)

+44 (0) 1253 898000 (U.K.)

+852 2366 4448 (Asia Pacific)

or

online at www.invibio.com