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X-spine Announces FDA Clearance of Novel Calix-PC Spinal Implant System

Wed, 11/16/2011 - 5:08am
MIAMISBURG, Ohio--(BUSINESS WIRE)--X-spine, a global manufacturer of devices for the treatment of spinal disease, today announced FDA clearance of the Calix PC™ Spinal Implant System to join its growing portfolio of innovative spinal devices. The Calix PC is an intervertebral body fusion system consisting of titanium coated PEEK (Polyetheretherketone) spinal implants. X-spine utilizes a unique plasma coating process to selectively adhere a frictional commercially-pure titanium coating to the bone-apposing surfaces of the device. As a result, the Calix PC demonstrates improved resistance to device expulsion versus a non-coated device in laboratory testing.

"The selective coating of plasma-sprayed titanium to a polymer substrate in an intervertebral implant is potentially the most important development in intervertebral fusion technology since the introduction of PEEK implants a decade ago," states Dr. David Kirschman, President and CEO of X-spine. "The Calix PC provides the benefit of a metallic surface while preserving the desirable qualities of PEEK, namely bone-equivalent modulus and radiolucency."

The Calix PC demonstrated 79% greater resistance to expulsion forces than the equivalent non-coated device in laboratory testing. "Optimal expulsion performance adds an additional safety factor in the critical early postoperative period," continues Dr. Kirschman. "This type of device exemplifies X-spines commitment to develop devices which add real value to the patient and surgeon. The clearance of the Calix PC represents the culmination of several years of technical hurdles to develop a safe, durable and reproducible process to integrate metallic and non-metallic biomaterials in a high-performance implant system."

The Calix PC system joins X-spines continually expanding portfolio of innovative spinal devices, including the AXLE™ Interspinous Fusion System, the FIXCET™ Facet Fixation 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.

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

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