Advanced Vertebral Solutions' Spinal Implant Made of Solvay's Zeniva® PEEK Receives FDA Clearance

Advanced Vertebral Solutions (AVS), a supplier of minimally invasive spinal implants and delivery systems, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Steerable TLIF spinal fusion implant made of Zeniva® polyetheretherketone (PEEK) resin from Solvay Advanced Polymers, LLC. Zeniva® PEEK - part of Solvay's Solviva® line of biomaterials - has a modulus very close to that of bone plus excellent toughness and fatigue resistance.
The EXPRESS IBFD™ TLIF implant, made from 30- and 40-mm-diameter Zeniva® PEEK rod stock, is an implant for interbody fusion of the anterior column of the spine. These implants are hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae. AVS has developed a unique "active steering" technology that minimizes instrument exchanges and simplifies the minimally invasive surgical technique, thereby enabling its rapid adoption among spine surgeons.

"Zeniva® PEEK provides the exceptional properties that are required of a high-precision implant in this critical application." said Mike Dugery, President of Advanced Vertebral Solutions.

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 permit x-ray procedures. Advanced Vertebral Solutions uses Zeniva® PEEK rod stock and performs high-precision machining to produce a full range of sizes and configurations.

"We're excited about the commercial adoption of Zeniva® PEEK for this unique spinal fusion implant," 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, not only with Zeniva® PEEK, but using the broad range of Solviva® Biomaterials.

In addition to Zeniva® PEEK, Solvay's Solviva® Biomaterials line includes Proniva® self-reinforced polyphenylene (SRP); Veriva® polyphenylsulfone (PPSU); and Eviva® polysulfone (PSU). These sterilizable products are available in resin for injection molding or extrusion.