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Eisertech to achieve FDA Clearance for new spinal implants made of Solvay’s Zeniva PEEK

News International-French

29 May 2012

Eisertech LLC, a San Diego, Calif.-based designer and manufacturer of cost-effective spinal implants, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new cervical cage and lumbar cage implants made of Zenivapolyetheretherketone (PEEK) rods from Solvay Specialty Polymers USA, LLC. ZenivaPEEK – part of Solvay’s line of SolvivaBiomaterials – 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.

The cage 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. “Zeniva® PEEK delivers the high-performance properties that are necessary for a high-precision implant used in cervical spine fusion surgery,” said Lukas Eisermann, president of Eisertech.

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. Eisertech buys Zeniva® PEEK rod stock directly from Solvay and machines and designs a full range of 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.”
Eisertech’s business model is focused on lowering the cost of spinal implants. Eisermann says the company’s products can be adopted by surgeons without having to attend a specialty training course, and can be serviced and re-ordered by hospital or surgery center staff via an online store without assistance from an on-site company representative. “This arrangement allows us to significantly streamline our business processes and infrastructure significantly relative to traditional full-service implant manufacturing companies,” said Eisermann. “That streamlining shows up as savings which we pass on to our customers.”

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 that 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 Eisertech

Eisertech LLC, based in San Diego, Calif., is a supplier of spinal implants made of Zeniva® polyetheretherketone (PEEK) rod stock from Solvay Specialty Polymers USA, LLC. The company was founded in 2010 by Lukas Eisermann who has a long track record of product development within the spinal surgery field. He is an active participant in the creation of intellectual property and is a named inventor on many U.S. and international patents. Eisermann has assisted in drafting ASTM standards for testing artificial disc devices, and is a co-author of several book chapters, journal articles, and conference proceedings. He has been a best paper nominee at major meetings, including the European Spine Society, IMAST, and NASS.
Eisertech products are provided for direct sale to healthcare facilities and are delivered via common commercial carriers. The company offers a high-value proposition for those customers that don’t require on-site service representation.


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.


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