ALPHARETTA, Ga., May 23, 2011 – Apollo Spine Inc., Newport Beach, Calif., a supplier of minimally invasive spinal implants, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Eclipse-L® vertebral interbody lumbar spacer and Eclipse-C® vertebral interbody cervical spacer made of Zeniva® polyetheretherketone (PEEK) resin from Solvay Advanced Polymers, LLC, a Solvay Specialty Polymers company. 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.
The spacer systems, made from 30- and 40-mm-diameter Zeniva PEEK rod stock, are implants that maintain disc space following a discectomy. These implants are hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae.
The Eclipse-C and Eclipse-L spacers feature a zero profile cage that achieves maximum fixation through an innovative design. They come in a range of sizes, variable diameters and lordotic angles to maximize a surgeon’s options to accommodate a patient’s natural anatomy. Another key feature is functional markers that offer better visualization of insertion depth without the use of external screws. Prominent serrations provide secure fixation at the end plates while a large central window optimizes loading capacity for bone graft material.
“Zeniva PEEK provides the exceptional properties that are required of a high-precision implant in this critical application,” said Dr. Kamran Aflatoon, director of design for Apollo Spine.
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. Apollo Spine uses Zeniva PEEK rod stock and contracts with fabricator STD Med Inc., Stoughton, Mass., to machine and design a full range of sizes and configurations.
“We’re excited about the commercial adoption of Zeniva PEEK for these unique spinal fusion spacers,” said Shawn Shorrock, global healthcare market manager for Solvay Advanced Polymers. “We’ve made significant investments and performed all applicable required testing to ensure that our Zeniva PEEK meets or exceeds the critical regulatory performance standards set by the FDA for this application.”
Zeniva PEEK and the entire line of 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 medical device manufacturers using Zeniva PEEK as well as other Solviva biomaterials.
In addition to Zeniva PEEK, the Solviva Biomaterials line includes Proniva® self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastic 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 stock shapes for machined components.
About Apollo Spine Inc.
Apollo Spine Inc., based in Newport Beach, Calif., is a supplier of spinal implants made using Zeniva polyetheretherketone (PEEK) resin from Solvay Advanced Polymers, LLC. The company is dedicated to being a global leader in the spine industry through the development of advanced and innovative spine technologies. Focus on optimal treatment of advanced degeneration, trauma, scoliosis, and spondylolisthesis includes motion preservation, minimal invasive techniques, and the enhancement of current market fusion treatments. Apollo Spine utilizes extensive surgeon collaboration and thorough research to assist in obtaining excellent spinal surgery outcomes, early mobilization, pain-free patients, and a fast return to a normal life. For more information, call (949) 757-0406 or visit www.apollospine.com.
