Solvay Announces TranS1 VEO® Interbody Fusion System Uses Spinal Implants Made of Solvay’s Zeniva® PEEK
ALPHARETTA, Ga., March 13, 2013– Solvay Specialty Polymers, a leading supplier of high-performance polymers, announced that TranS1 Inc., a leading supplier of minimally invasive spinal implants and medical devices, based in Raleigh, N.C, has commercialized the VEO® Direct Lateral Access and Interbody Fusion System which incorporates a lumbar fusion cage implant made of Solvay’sZeniva® polyetheretherketone (PEEK) resin. The VEO system also features a tubular retractor made of Solvay’s Radel® polyphenylsulfone (PPSU) resin for radiolucency and ability to withstand repeated steam sterilization. TranS1’s use of Zeniva® PEEK and Radel® PPSU highlights the advantages of working with a supplier like Solvay that offers a broad range of materials for the healthcare industry.
TranS1’s VEO is a direct lateral fusion system for the lumbar spine. VEO’s interbody cage is made from Zeniva® PEEK rod stock that TranS1 offers in various sizes, including widths of 17-mm and 22-mm and lengths from 40-mm to 60-mm. The implant has a large center channel to allow bone growth through the device, fusing the adjacent bony surfaces of the vertebrae. 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. It is certified to meet the full requirements of the ASTM F2026 standard for PEEK used in implantable surgical devices.
The VEO Direct Lateral System brings clear and direct visualization to lateral fusion surgery. Through a combination of direct psoas visualization and clear lateral fluoroscopic views, the VEO Direct Lateral System offers complete visualization of the operative site. This approach was designed to help minimize iatrogenic trauma to the psoas muscle and the nerve plexus to help reduce the risk of post-operative complications.
The VEO Direct Lateral System offers a comprehensive portfolio of interbody implants in both parallel and lordotic angles to match each patient’s anatomy. The interbody implants made using Zeniva® PEEK contain five tantalum markers for precise fluoroscopic visualization. The large center channel is readily visualized and can be easily evaluated for progression of fusion.
Zeniva® PEEK is a comparable or better-performing alternative to 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 enable x-ray procedures without interference.
“This is a perfect example of the value Solvay brings with its breadth of products, expanding the options for designers in terms of design flexibility and performance optimization,” said Shawn Shorrock, global healthcare market manager for Solvay Specialty Polymers. “In addition, the ongoing acceptance of Zeniva® PEEK has validated our approach to the spinal market and we’re encouraged by the momentum we’ve generated.”
Meanwhile, TranS1 was able to draw again on Solvay’s extensive product offering by using Radel® PPSU for the tubular retractor that was designed to prevent soft tissue intrusion. The high-performance material provides superior strength, high thermal performance, chemical resistance, and the ability to withstand repeated steam sterilization. The retractor is made from 50-mm diameter Radel® PPSU rod stock in lengths of 100-mm, 120-mm, and 140-mm.
The manufacturing site for Zeniva® PEEK and other Solviva® Biomaterials in Alpharetta, Ga., is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an ISO 17025 accredited lab.
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 that offers exceptional chemical resistance and hardness; Veriva® polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent chemical resistance; 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 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 ‚Äì fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra polymers, high-barrier polymers and cross-linked high-performance compounds ‚Äì for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other markets.
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).As an international chemical group, SOLVAY assists industries in finding and implementing ever more responsible and value-creating solutions. Solvay generates 90% of its net sales in activities where it is among the world's top three players. It serves many markets, varying from energy and the environment to automotive and aerospace or electricity and electronics, with one goal: to raise the performance of its clients and improve society's quality of life. The group is headquartered in Brussels, employs about 29,400 people in 56 countries and generated 9.9 billion euros in net sales in 2013. Solvay SA is listed as SOLB.BE on NYSE Euronext in Brussels and Paris (Bloomberg: SOLB:BB - Reuters: SOLB.BR).