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.