Nexxt Spine Is Granted FDA Clearance for New Spinal Implants Made of Solvay's Zeniva® PEEK
Solvay Advanced Polymers, L.L.C.
4500 McGinnis Ferry Road
Alpharette, GA, 30005-3914
Press release date: September 18, 2012
Thermoplastic Biomaterial Brings High Performance to New Spinal Spacer System Devices
ALPHARETTA, Ga. Nexxt Spine LLC, a Fishers, Ind.-based manufacturer of spinal implants and instrumentation, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Honour(TM) cervical spacer and lumbar spacer implants made of Zeniva® polyetheretherketone (PEEK) rods from Solvay Specialty Polymers USA, LLC. Zeniva® PEEK - 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.
Nexxt Spine's new Honour(TM) Spacer System consists of three unique implants which are offered in various footprints, with indications ranging from the cervical to the lumbar spine. The system is versatile enough to accommodate unilateral (TLIF and oblique) and bilateral (PLIF) approaches in the lumbar spine with the option to insert directly or initially on its side to prevent over-distraction of the ligamentous and nerve structure, according to the company. The spacer systems, made from various sizes of Zeniva® PEEK rods, are hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae.
"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 Eric Lintula, Director of Engineering for Nexxt Spine.
Lintula added that the use of Zeniva® PEEK in the structural portion of the spacer resulted in extraordinary repeatability. "Since the core function of the spacer is to restore the original disc height and maintain this height under physiological loads until arthrodesis occurs, having repeatable compressive strength gives our surgeons confidence they will have consistent clinical results," explained Lintula.
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. Nexxt Spine buys Zeniva® PEEK rod stock directly from Solvay Specialty Polymers and machines and designs a full range of spacer 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."
Nexxt Spine plans to use Zeniva® PEEK in the expansion of its Honour(TM) Spacer System product line.
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 Nexxt Spine
Nexxt Spine LLC is a privately held manufacturer of spinal implants and instrumentation and is headquartered in Indianapolis, Ind. Nexxt Spine manufactures their own product line and thus offers exceptional quality, American-made implants, hardware, and custom instrumentation for a range of spinal implant needs. Founded in 2008, Nexxt Spine supports the value-based purchasing model by utilizing superior raw materials and local manufacturing, while offering more fiscally responsible pricing to hospitals and surgery centers. Andy Elsbury, President of Nexxt Spine, has over 15 years of experience managing design and development of spinal instrumentation and implants, both as a consultant and contractor for companies including JNJ (DePuy) and Medtronic. For more information, visit www.nexxtspine.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. Its recent acquisition of specialty chemicals company Rhodia created a much larger player which 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 its customers' performance in markets such as consumer goods, construction, automotive, energy, water and environment, and electronics. The Group is headquartered in Brussels and its companies employ about 29,000 people in 55 countries and generated EUR 12.7 billion in net sales in 2011 (pro forma). Solvay SA (Solvay SA (SOLB.BE) is listed on NYSE Euronext in Brussels and Paris (Bloomberg: SOLB.BB - Reuters: SOLBt.BR).