SpineNet is Granted FDA Clearance of New Cervical Cage implants made of Solvay’s Zeniva PEEK
ALPHARETTA, Ga.- SpineNet LLC, a Winter Park, Fla.-based manufacturer of spinal fusion implants, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new SpineNet ACC(TM) anterior cervical cage made of Zeniva® polyetheretherketone (PEEK) rods from Solvay Specialty Polymers USA, LLC.
Zeniva® PEEK, which is part of Solvay's line of Solviva® Biomaterials, has a modulus very close to that of bone plus excellent toughness and fatigue resistance. The FDA clearance was based in part on Solvay's well-developed master access file for Zeniva® PEEK.
SpineNet's new SpineNet ACC(TM) cervical cage is designed to reproduce a tri-cortical iliac crest bone, providing structural support as an interbody spacer for anterior cervical fusions. The superior and inferior surfaces allow for intimate contact with the endplate surfaces for optimum stability and to resist subsidence. The FDA-approved ACC cervical cages are offered in 10x12 mm and 12x14 mm footprints (5-10 mm height) with multiple sizing options. The ACC implants, made from various sizes of Zeniva® PEEK rods, have windows which allow bone to grow through the device, fusing the adjacent bony surfaces of the vertebrae. Radiopaque tantalum rod markers allow for improved positioning.
"We chose Zeniva® PEEK for its similarity to the modulus of elasticity of bone, radiographic properties, and the widespread commercial and regulatory acceptance of the material," said Rick Kitain, vice president of SpineNet.
Zeniva® PEEK offers numerous advantages over metals such as titanium for these intervertebral implantable devices. The material offers many important benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone. Based on biocompatibility testing, Zeniva® PEEK demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and has radiolucent properties which permit x-ray procedures. SpineNet buys Zeniva® PEEK rod stock directly from Solvay Specialty Polymers and machines and designs a full range of cervical cage sizes and configurations.
"We're excited about the commercial success of Zeniva® PEEK in the spinal fusion market," said Shawn Shorrock, global healthcare market manager for Solvay Specialty Polymers. "The ongoing acceptance of Zeniva® PEEK has validated our approach to the spinal market and we're encouraged by the momentum we've generated."
Kitain says SpineNet plans to use Zeniva® PEEK in future designs of lumbar interbody devices.
Zeniva® PEEK and the entire line of thermoplastic Solviva® Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay's biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.
Solvay is currently in active product trials with several major medical device manufacturers using Zeniva® PEEK and other Solviva® Biomaterials.
In addition to Zeniva® PEEK, Solvay's Solviva® Biomaterials line includes Proniva® self-reinforced polyphenylene (SRP), one of the world's stiffest and strongest unreinforced thermoplastics, which offers exceptional hardness and biocompatibility; Veriva® polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva® polysulfone (PSU), which offers practical toughness in a strong, transparent polymer. These sterilizable products are available in injection molding and extrusion grades as well as rods and plates for machined components.
About SpineNet LLC
SpineNet LLC, founded in 2007, is a complete solutions provider of spinal fusion devices. The company's primary mission is to provide surgeons and their patients with the highest quality medical implants, elite service, and total peace of mind. SpineNet offers an extensive line of state-of-the-art fusion systems. The company has partnered with key surgeons, proven industry leaders, and a world-class development team to manufacture leading-edge implant products for the surgical spinal fusion market. For more information, visit www.spinenetllc.com
About Solvay Specialty Polymers
Solvay Specialty Polymers is a leading global supplier of high-performance thermoplastics for implantable and non-implantable medical devices. The company has expanded its focus on the healthcare industry to meet the growing needs of its global customers. Last year, Solvay announced a new organizational structure and a 50% increase in staffing for sales, marketing, and technology functions in the U.S. and Europe. Plans for further expansion in Asia-Pacific are also underway. Solvay is building on its 20-year history as a key material supplier in the healthcare field, devoting considerable new resources to help customers be more efficient and cut costs. Metal-to-plastic replacement remains a key focus for manufacturers, but increased cost pressures pose a new challenge as the market continues to grow at a double-digit pace. Solvay also continues to devote considerable research and development activities to polymer technology and commercialization of new and unique material options for medical OEMs and processors.
Solvay Specialty Polymers manufactures more products with more performance than any other polymer company in the world. The company supplies over 1500 products across 33 brands of high-performance polymers - fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra polymers, high-barrier polymers and cross-linked high-performance compounds - for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other markets. Learn more at www.solvayspecialtypolymers.com.
Solvay is an international chemical Group committed to sustainable development with a clear focus on innovation and operational excellence. It is realizing over 90% of its sales in markets where it is among the top 3 global leaders. Solvay offers a broad range of products that contribute to improving quality of life and the performance of its customers in markets such as consumer goods, construction, automotive, energy, water and environment, and electronics. The Group is headquartered in Brussels and its companies, which employ about 31,000 people in 55 countries, generated EUR 12.7 billion in net sales in 2011 (pro forma). Solvay SA (SOLB.BE) is listed on NYSE Euronext in Brussels and Paris (Bloomberg: SOLB.BB - Reuters: SOLBt.BR).