Solvay Announces TranS1 VEO® Interbody Fusion System Uses Spinal Implants Made of Solvay's Zeniva® PEEK
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Solvay Advanced Polymers, LLC
4500 McGinnis Ferry Road
Alpharette, GA, 30005-3914
Press release date: March 14, 2013
Spinal Fusion Device Also Taps Radel® PPSU for Tubular Retractor
ALPHARETTA, Ga. – 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's Zeniva® polyetheretherketone (PEEK) resin. The VEO system also features a tubular retractor made of Solvay's Radel® polyphenylsulfone (PPSU) resin for radiolucency and the 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. 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 high-performance plastics than any other company in the world. The company supplies over 1500 products across 35 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 and Gas, Packaging, Plumbing, Semiconductors, Wire and 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).
About TranS1 Inc.
TranS1 is a medical device company focused on designing, developing, and marketing products to treat degenerative conditions of the spine affecting the lumbar region. TranS1 currently markets the AxiaLIF family of products for single and two level lumbar fusion, the VEO lateral access and interbody fusion system and the VectreTM posterior fixation system for lumbar fixation supplemental to AxiaLIF fusion. TranS1 was founded in May 2000 and is headquartered in Raleigh, North Carolina. For more information, visit www.trans1.com.